Pfizer

Cardiovascular symptom reports

Female, 40 - 59 years

Age Reported Symptoms Notes
40 2020-12-31 chest discomfort CAREGIVER RECEIVED FIRST VACCINE DOSE AND SOON AFTER BEGAN TO FEEL DIZZY AND HER EYES BEGAN TO TWITC... Read more
CAREGIVER RECEIVED FIRST VACCINE DOSE AND SOON AFTER BEGAN TO FEEL DIZZY AND HER EYES BEGAN TO TWITCH, FOLLOWED BY UNCONTROLLED SHAKING, WITH HIGH FEVER FOLLOWED BY SEVERE SHORTNESS OF BREATH AND GASPING, WITH TIGHTNESS AROUND THE CHEST. TRANSPORTED TO EMERGENCY DEPARTMENT. HAD MULTIPLE EPISODES OF ITEMS LISTED ABOVE WHILE IN ED, INCLUDING HEAVINESS IN HER LEGS AND TINGLING IN ARMS. SHE WAS DISCHARGED FROM ED AT 10:30PM BUT WAS READMITTED ON 12/24 TO ED FOLLOWING SIMILAR ISSUES. TO DATE SHE HAS HAD 5 RAPID RESPONSES IN HOSPITAL DUE TO REPEAT OF SIGNS/SYMPTOMS. CT AND PULMONOLOGY CONSULT SCHEDULED FOR 12/28/2020.
40 2021-01-01 palpitations Employee complained of palpitations and feeling warm for approximately 15 minutes, symptoms resolved... Read more
Employee complained of palpitations and feeling warm for approximately 15 minutes, symptoms resolved on their own. employee is 14 weeks pregnant.
40 2021-01-03 chest discomfort Chest started tightening then started having a hard time swallowing. Felt dizzy, faint, and as thoug... Read more
Chest started tightening then started having a hard time swallowing. Felt dizzy, faint, and as though I was going to pass out. Epi pen was administered when I wasn't able to swallow. Was taken to ER on a stretcher, however they said on the way, I wasn't responding and couldn't open my eyes. Muscles began cramping and loss sensation in limbs. Hands wouldn't open up as they cramped. Blood pressure kept going up and down.
40 2021-01-03 chest discomfort Fatigue, myalgias, arthralgias, headache, rhinorrhea, scratchy throat, chest tightness - approximate... Read more
Fatigue, myalgias, arthralgias, headache, rhinorrhea, scratchy throat, chest tightness - approximately 72 hours duration
40 2021-01-03 lightheadedness I had seizure like 3 times; Vasovagal reaction; Fever; Headache; Weakness; It's just little bit shak... Read more
I had seizure like 3 times; Vasovagal reaction; Fever; Headache; Weakness; It's just little bit shaky and breathless; It's just little bit shaky and breathless; allergic reaction; This is a spontaneous report from a contactable consumer. A 40-year-old female patient received bnt162b2 (BNT162B2, lot number: EK5730), via an unspecified route of administration on 24Dec2020 at a single dose for covid-19 vaccination. There were no relevant medical history and concomitant medications. The patient reported that on an unspecified date, she had an allergic reaction. She had vasovagal reaction and seizures. Vasovagal was an allergic reaction that happened, and added that basically it's an allergic reaction. The patient experienced fever, headache, and weakness like right now. It was just little bit shaky, ever since yesterday and she had been way off like she take it as instruction yesterday, weakness, headache and breathless did not stopped from yesterday. The patient had been taking Tylenol for fever and headache. The patient reported that the events persisted. On 24Dec2020, lab work was done at the hospital, and she was told that the lab work was okay and they did CT scan of head because she developed seizure. She had seizure like 3 times so they scanned her brain. The outcome of the events was not recovered.
40 2021-01-04 heart rate increased 12/19 - Elevated heart rate, trouble breathing. No med attn needed. 12/23 - 7pm Chills (2hrs), 9pm... Read more
12/19 - Elevated heart rate, trouble breathing. No med attn needed. 12/23 - 7pm Chills (2hrs), 9pm low grade fever, 11pm 101.2 fever, body aches, fatigue (2 days). Took Ibuprofen. Fever did not go over 99 after Ibuprofen. 2-3 episodes of diarrhea. Seen by PCP on 12/24 via after hours clinic. Recovered in 4 days.
40 2021-01-04 blood pressure increased Intially started as lip numbness, then tongue, lasting for about 10-15 minutes. It went away, then ... Read more
Intially started as lip numbness, then tongue, lasting for about 10-15 minutes. It went away, then about 10 minutes later her Right arm became numb, then it returned to her lips on the Right side of her mouth, and then feeling wobbly, weakness on the Right leg. Elevated blood pressure, 182/112. Got medication prescribed and is lowerin blood pressure now, within an hour of taking medication, but numbness remains.
40 2021-01-05 fast heart rate Approximately 5 minutes after vaccine administration, patient began to feel flushed and she was tach... Read more
Approximately 5 minutes after vaccine administration, patient began to feel flushed and she was tachycardia. Brought patient away from public area, gave cool pack, oxygen and called EMS. EMS monitored patient and issue resolved within 20 minutes.
40 2021-01-05 chest discomfort Chest heaviness and pressure about 10 minutes afterwards, got better then came back multiple times t... Read more
Chest heaviness and pressure about 10 minutes afterwards, got better then came back multiple times that same day. I also had sore throat and funny taste in my mouth. That night is when I mainly definite effects, chills, fatigue, body aches, low grade fever and head ache. Wednesday and Thursday I was in bed with fever, nasal congestion, body aches. Friday I started to feel better and function. By Saturday I was fine. Was in communication with my PCP. My daughter, 3 years old tested positive for Covid on 1/4/2021 and now I'm starting to feel bad.
40 2021-01-05 chest discomfort, heart rate increased Patient became anxious, felt her throat closing and pressure in her chest. Pulse rate increased. R... Read more
Patient became anxious, felt her throat closing and pressure in her chest. Pulse rate increased. Rash noted initially on arms, chest, and back. Palms of hand became very red. Shortly after, she became hoarse, and hives were noted on chest and neck.
40 2021-01-05 loss of consciousness, fainting Pfizer-BioNTech COVID-19 Vaccine. Patient received COVID vaccination on 1/5/2021 and began feeling d... Read more
Pfizer-BioNTech COVID-19 Vaccine. Patient received COVID vaccination on 1/5/2021 and began feeling dizzy, light-headed and then had a witnessed syncopal episode with seizure-like activity, vomiting and loss of consciousness. Onset of symptoms were almost immediately following receipt of the vaccine. Patient demonstrated seizure-like activity again while in the ED. Patient received lorazepam 1 mg IV, diphenhydramine 50 mg IV, Lactated Ringers 500 ml IV bolus, NS 1000 ml bolus, potassium bicarbonate 25 mEq. Patient ED visit 0852 until 1404. Patient responded well to treatment and was discharged in stable condition.
40 2021-01-05 palpitations, pallor Started with tingling in arms and hands within 5 minutes, then tingling in tongue, and heart racing,... Read more
Started with tingling in arms and hands within 5 minutes, then tingling in tongue, and heart racing, lead to difficulty breathing and turning pale. Staff stuck me with an EpiPen in my right thigh and EMT was called and Benadryl was administered.
40 2021-01-06 heart rate irregular I woke the next morning with flu like symptoms my arm was hurting, I was feelin tired and really cou... Read more
I woke the next morning with flu like symptoms my arm was hurting, I was feelin tired and really couldn't get out of bed. As the day progressed I got chills, started running a fever, It went up to 104 and my heart rate went up and down from 120-165 so I went to the ER. They gave me fluids and ran a whole bunch of test, tested me for Covid and Sepsis and everything came back normal and negative for Covid. They monitored my heart rate and once it started getting back to normal, they ended up letting me go home, I was there from 8pm to about 3am. After that I felt tired and felt like when I had Covid back in November. I started feeling better about Sunday, still a little tired but felt more back to normal. My heart rate is still getting back to normal so my Dr is following me on that.
40 2021-01-06 palpitations, hypertension Palpitations & HYPERtension Narrative: 143/94 98, 100% on RA, 98.2 degrees, rr 14 at 1457. 158/96, 9... Read more
Palpitations & HYPERtension Narrative: 143/94 98, 100% on RA, 98.2 degrees, rr 14 at 1457. 158/96, 97, 100% on RA, rr 16 at 1501. Denied headache, rash, SOB, uticaria. 138/87, 85, 100% on RA at 1530. Denied dizziness and palpitations. History of palpitations. History of anaphylaxis allergy to IV iodine.
40 2021-01-07 loss of consciousness Acute allergic reaction Tongue swelling Facial swelling Throat swelling Rash on throat and chest Re... Read more
Acute allergic reaction Tongue swelling Facial swelling Throat swelling Rash on throat and chest Redness in throat Diaphoresis Momentary loss of consciousness
40 2021-01-07 chest discomfort After receiving injection, patient reported SOB, chest tightness, hand tremor, and seeing stars. Ra... Read more
After receiving injection, patient reported SOB, chest tightness, hand tremor, and seeing stars. Rapid response called , patient observed for 30 minutes and walked to car. Patient then presented to emergency department at 12:06pm with concern for reaction and h/o heart mumur as a child. Patient referred to Urgent Care Clinic and presented at 12:30, endorsed headache and anxiety. Patient received acetaminophen 1,000mg PO x 1 dose, diphenhydramine 25mg PO x 1 dose, and ibuprofen 600mg PO x 1 dose in Urgent Care. Crackers and water given. Patient provided education on managing anxiety and discharged.
40 2021-01-07 loss of consciousness Around at 7AM when I arrived at work I started feeling chills, took temperature 99.5F that is alread... Read more
Around at 7AM when I arrived at work I started feeling chills, took temperature 99.5F that is already elevated for me. About 9:30 my temp was 101.8F and they sent me home. I just had the chills and fever. I got home and developed a headache and around 1PM I started feeling really dizzy. The temperature did not subside and the next day I woke up and I couldn't function, I felt really dizzy I kept laying down and drinking water, I could not keep anything down my stomach did not feel well. I felt like I had to vomit. When I sat down in the toilet then my ears started ringing pretty bad all of a sudden I could not hear anything and I passed out in the toilet. My husband found me and tried to wake me up. After that I still feel dizzy. I did not have any appetite either. I could barely hold water. The next day I was not as dizzy but my stomach was still upset but I could hold some soup down but then started with diarrhea. Employee health kept calling me everyday and I did the the telehealth appt and I also had a little bit of a rash in my chest that appeared all of a sudden red like a streak. The dizziness I had for the first 4 days, diarrhea did not come until the 3rd day and I had it for 2 days and my temperature was back to normal on the 4th day. Everything started to get better (my stomach stopped feeling queezy) around the 4th day but still felt fatigued until about 12/29/2020.
40 2021-01-07 fast heart rate, hypotension Initial itching at injection site, observed and returned to work. Came back ~30-40 minutes later wit... Read more
Initial itching at injection site, observed and returned to work. Came back ~30-40 minutes later with itchiness in throat and hives to arm. Given Benadryl PO and observed for extended period of time. Symptoms not resolving. Patient transferred to Emergency Department for further care. At that point observed to have full body rash, SOB. Given Epi while in ED. Developed tachycardia, hypotension. Treatment continued.
40 2021-01-07 heart rate increased, heart rate increased Patient was given Covid Vaccine. She went to the waiting area to sit for the 15 min wait. She then c... Read more
Patient was given Covid Vaccine. She went to the waiting area to sit for the 15 min wait. She then came to the front desk to inform us that her heart rate was elevated and wanted to speak to a nurse. We then notified the nursing staff and took her to a room to be evaluated. After about 15-20 min nursing staff asked front desk to call 911.
40 2021-01-07 chest discomfort Pfizer-BioNTech COVID-19 Vaccine Approximately 24 hours after injection I felt dyspnea with minimal... Read more
Pfizer-BioNTech COVID-19 Vaccine Approximately 24 hours after injection I felt dyspnea with minimal exertion and at rest while wearing my hospital mask, which I attributed to the cheap quality of the mask. Breathlessness was relieved after I took it off. I shoveled snow with no problem over the weekend, and was off work. Three days later, on 1/3 around 7 pm, I experience the same feeling while wearing the same type of mask, and it was relieve when I took it off. The following day, 1/4 around 2pm, while wearing a different disposable mask in the grocery store, felt extremely overheated and realized I was having difficulty breathing with minimal exertion. This time the feeling did not pass when I left the store/removed my mask, and residual effects of not being able to easily take a deep breath stayed with me the entire day. The feeling was gone in the morning, but did eventually re-occur the next day (tightness in my lungs not allowing for easy deep breaths) on 1/5 near the end of a shift where I had been wearing yet a different type of disposable mask. The symptoms starting around 4:30 pm and lasted throughout the rest of the evening. At this point I notified employee heath and scheduled a covid test. The next two days, on 1/6 and 1/7, the same type of dyspnea persisted throughout the day; while at rest, not relieved, and with no other symptoms (no cough, fever, etc.) Ibuprofen appears to relieve the discomfort, and I have returned to work, however the symptoms are still present if I am not taking Ibuprofen. Possibly some kind of pleurisy. My lung sounds are clear.
40 2021-01-07 chest discomfort, palpitations Received vaccine at 1730, then just before midnight my heart began to pound hard and very fast, and ... Read more
Received vaccine at 1730, then just before midnight my heart began to pound hard and very fast, and it made me feel short of breath or as though I had to cough. After about a minute I thought it might be SVT so I did a valsalva maneuver and it stopped. I was resting in bed, no alcohol or caffeine, and this has never happened to me before. Since then, I have felt at least one heart palpitation per day, sometimes many more. The last few days I have felt extremely fatigued and have had an odd sensation in my chest. On 1/7 I developed a dry cough, and was swabbed for Covid because I felt so bad. It was negative. This made me wonder if the odd sensation in my chest was related to my heart and not my lungs. I am due for my second vaccine today, and am unsure if I should get it.
40 2021-01-07 chest pain Severe Headaches Body aches Fatigue Chest pain allergies worsened
40 2021-01-08 chest discomfort 1/6/21: left arm soreness and decreased range of motion around 5pm. lower extremity weakness and pa... Read more
1/6/21: left arm soreness and decreased range of motion around 5pm. lower extremity weakness and pain, skin sensitivity (feeling like a sunburn when touched) chills and fever (100.4) around 8pm. 1/7/21: fever (101.1), headache, dental/jaw pain around 2am. Nausea started around 6am. Fever lasted all night till around 10am. Blood pressure 138/85 and resting HR 125 and fever started again around 12pm. Chest tightness during exhalation around 2pm. Went to the Emergency Room around 2:30pm. Fever and headache returned around 8pm and gone by 10pm.
40 2021-01-08 chest discomfort, heart rate increased 11:30 SHOT GIVEN, BY 11:40 FELT TINGLING IN LIPS AND THROAT AND HEART RATE 125 (MY RESTING HEARTRATE... Read more
11:30 SHOT GIVEN, BY 11:40 FELT TINGLING IN LIPS AND THROAT AND HEART RATE 125 (MY RESTING HEARTRATE IS 68), BY 11:45 TIGHTNESS IN CHEST AND NECK, HEARTRATE STILL 125 RANGE, NOON: BP 154/75 (MY NORMAL IS 96/58) AND HIVES 12:10 BENADRYL (25MG) GIVEN 12:25: BP 163/78 AND ALL OTHER SYMPTOMS STILL PRESENT 1:00 SECOND BENADRYL (25MG) GIVEN 1:11: BP 158/78 1:45 HEARING TURNED MUFFLED MOVED DOWNSTAIRS TO ER SECTION AT HOSPITAL GIVEN STEROIDS, PEPCID AND WATCHED FOR ADDITIONAL TIME ON 1/9/21: STILL ON BENADRYL AND STEROIDS: WOKE UP AT 8:00 AM SORE ARM AND SLIGHT HEADACHE, 9:00 RED SPLOTCHES ON FACE, NECK AND CHEST, 11:30AM ON 1/9/21: TIGHTNESS IN CHEST AND NECK CONTINUING STEROIDS AND BENADRYL
40 2021-01-08 palpitations Shaking chills, nausea/vomiting, headache, palpitations. No symptoms with initial vaccine.
40 2021-01-08 fast heart rate dizziness, fever, chills, tachycardia > 90 bpm
40 2021-01-09 pallor, palpitations After sitting down in the observation area and I was just starting to register for vsafe my heart st... Read more
After sitting down in the observation area and I was just starting to register for vsafe my heart started to pound then I experienced a hot flushed feeling that went through my entire body and my heart started racing and felt not well. I told the nurses what happened and they said I looked pale. I laid down and started to feel better after a few minutes.
40 2021-01-09 chest pain Immediate redness/burning of the injection site. Progressed to itchy throat/tongue and hoarse voice ... Read more
Immediate redness/burning of the injection site. Progressed to itchy throat/tongue and hoarse voice with persistent wheezy cough after 5 min Progressed to itchy/burning/red face/chest/ears after 10 min. Wheeled to the emergency department 20-25 minutes after injection. Had to have benadryl, solumedrol, pepcid, zofran, and an epinephrine injection to stop the anaphylaxic reaction.
40 2021-01-10 chest discomfort 0808- shot 0812- face got extremely red and hot- burning from inside out 0816- nausea 0829- started ... Read more
0808- shot 0812- face got extremely red and hot- burning from inside out 0816- nausea 0829- started to feel chest get tight and began wheezing 0850- went home - itchy on chest stomach, back, and chin/throat. Still very red. 0915- took Benadryl did breathing treatment- cold pack to face 1015- itchy- less- headache, no wheezing no nausea- fell asleep 1215- woke up- chest tight- did breathing treatment- headache 1515- took another 25mg Benadryl Slept most of day til next morning. Went to work 12/29/21 at 6am by 12 feeling really under the weather and tired. Went home took Motrin600mg and went to bed . 12/30 went to work back to normal
40 2021-01-10 fast heart rate Auditory & visual hallucinations; Auditory & visual hallucinations; tachycardia; extreme panic; conf... Read more
Auditory & visual hallucinations; Auditory & visual hallucinations; tachycardia; extreme panic; confusion; felt like skin was on fire/pulsating; felt like skin was on fire/pulsating; severe pain especially at knees/hips/base of head and neck; severe pain especially at knees/hips/base of head and neck; severe pain especially at knees/hips/base of head and neck; uncontrollable vomiting; bad chills and fever; bad chills and fever; insomnia; felt as if she had been given drugs; This is Spontaneous report from a contactable Other Healthcare Professional reported for herself. This 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EK9231), via an unspecified route of administration on 04Jan2021 14:30 at single dose on right arm for COVID-19 immunization. Medical history included COVID prior vaccination and latex allergy. There were no concomitant medications. No other vaccine in four weeks. The patient previously had allergic to diazepam (VALIUM), clonazepam (KLONOPIN), ondansetron (ZOFRAN) and lorazepam (ATIVAN). The patient experienced auditory & visual hallucinations, tachycardia, extreme panic, confusion, felt like skin was on fire/pulsating, severe pain especially at knees/hips/base of head and neck, uncontrollable vomiting, bad chills and fever, insomnia. She felt as if she had been given drugs. All of the events happened on 05Jan2021 01:30 and resulted in Doctor or other healthcare Recovering professional office/clinic visit. No treatment received for the events. No COVID tested post vaccination. The outcome of the events was recovering.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Auditory hallucinations and Visual hallucinations cannot be totally excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
40 2021-01-10 palpitations Palpitations, anxious, no temperature but my body feels really hot in the inside, very bad pain unde... Read more
Palpitations, anxious, no temperature but my body feels really hot in the inside, very bad pain under the arm pit close to my breast on the arm of vaccine, weak ,lightheaded, sweating, headache,
40 2021-01-10 heart rate increased Roughly 3.5 hours after injection heart rate jumped to 161 out of the blue all of a sudden; I was ab... Read more
Roughly 3.5 hours after injection heart rate jumped to 161 out of the blue all of a sudden; I was able to lay down in the vehicle as we were traveling from home to location and after about 5-10 minutes of laying back my HR lowered to between 100-120; arrived at ED around 6:45 and while waiting 4 hours in waiting rom area to be seen HR remained around 110-115 for the 4 hours straight and finally after about 5-6 hours it retuned to normal rate.
40 2021-01-10 fast heart rate, blood pressure increased Tongue swelling, headache, tachycardia, elevated BP
40 2021-01-10 fainting Vaccine recipient received vaccine on 1/8/2021. At the end of her 15 minute observation had a vasova... Read more
Vaccine recipient received vaccine on 1/8/2021. At the end of her 15 minute observation had a vasovagal episode with diaphoresis, lightheadedness and dizziness. She was sent to the ED for further observation and had experienced nausea and vomiting. She was given Zofran. She was stable and discharged from the ED.
40 2021-01-10 heart rate increased c/o rapid pulse, anxiousness
40 2021-01-10 hypertension, fainting, chest discomfort lightheaded ness and near syncope bradycardia as hypotension started about 10 minutes after vaccine ... Read more
lightheaded ness and near syncope bradycardia as hypotension started about 10 minutes after vaccine administered. about 1 hour later had wheezing and chest tightness lasting about 4 hours
40 2021-01-10 chest pain pinching type of chest pain
40 2021-01-11 chest pain lymphedema in armpit, pain in armpit, lymphedema in left chest, pain in left chest; started 1/9/2021... Read more
lymphedema in armpit, pain in armpit, lymphedema in left chest, pain in left chest; started 1/9/2021 in the morning, worsened over the next 48 hours; swelling progressed to level that made resting arm against body too painful, lifting arm above level of shoulder too painful, lifting objects in left hand too painful, deep breathe caused pain in left chest and rib/flank area, swelling in chest area progressed across chest toward neck and covering clavicle. swelling continued to increase until 1/12/2021, the first day which swelling and pain has decreased.
40 2021-01-11 chest discomfort shortness of breath; tightness in her chest; This is a spontaneous report from a contactable nurse (... Read more
shortness of breath; tightness in her chest; This is a spontaneous report from a contactable nurse (patient). A 40-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Lot Number: EL0140, expiry date: 19 Vaccine: Mar2021, via an unspecified route of administration in the left arm from 29Dec2020 16:00 to 29Dec2020 16:00 as SINGLE DOSE for COVID-19 immunisation. Medical history included blood pressure abnormal (She has been on blood pressure med for 3 years). Concomitant medication included labetalol oral 200 mg, 2x/day for Blood pressure. The patient reports since Sunday night, 03Jan2021, she noticed feeling a little tightness in her chest and shortness of breath but her O2 saturation is fine. Reports she tested it at 98% to 97%. Asking is this a side effect of the vaccine, has it been reported? Does it have anything to do with the expected effectiveness after a week of getting the first dose? She is scheduled for the second dose 18Jan2021. The outcome of the events was not recovered.
40 2021-01-12 fast heart rate, lightheadedness Patient experiencing moderate-severe body aches, chills, feeling of burning all over skin, skin flus... Read more
Patient experiencing moderate-severe body aches, chills, feeling of burning all over skin, skin flushing, nausea, headache, dizziness, near syncope, and bouts of being tachycardia. acetaminophen 1gm q6 hours x 4 doses for 2 days ondansetron 4mg x 1 dose
40 2021-01-12 heart rate increased Systemic: increased heart rate-Mild; symptoms lasted 0 days
40 2021-01-12 chest discomfort, chest pain This is a 40 y/o woman with a past history of re-entry supraventricular tachycardia who is s/p ablat... Read more
This is a 40 y/o woman with a past history of re-entry supraventricular tachycardia who is s/p ablation in October, 2020 who presented to our Emergency Room on 1/12/21 due to the abrupt onset of left sided chest discomfort and diaphoresis. The patient awoke from sleep with this sensation. Chest pain was sharp, unchanged since onset, without ameliorating/exacerbating factor or activity. Participated in physical fitness training on day prior to presentation without unusual exertion or activity. Mild nausea on day of presentation. Obtained COVID-19 vaccine the day prior. No history of adverse reaction to vaccines in past. Normal labs/troponin and patient was sent home. Normal ECG. Following ablation in October, Following ablation in Oct, 2020, the patient reports no return of symptoms.
40 2021-01-13 heart rate increased EKG which showed some abnormal activity; resting heart rate rose to 113, and remained between 110-11... Read more
EKG which showed some abnormal activity; resting heart rate rose to 113, and remained between 110-113 for 48 hours/her resting heart rate was elevated around 110-115; she felt slightly short of breath; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0140 and expiration date Mar2021), intramuscular (top of her right arm) first dose on 29Dec2020 11:00 at single dose for Covid-19 immunization. The patient's medical history included ongoing allergic to contrast dye, allergic to dust, and covid from Apr2020. There were no concomitant medications. The patient had the first dose of the Pfizer covid vaccine and she had an uncommon reaction. She received the first dose of the covid vaccine on 29Dec2020 around 11am. 24 hours after receiving the vaccine on 30Dec2020 around 11am she felt slightly short of breath and her resting heart rate was rose to 113, and remained between 110-113, elevated around 110-115. Her heart rate stayed elevated for about 2 hours. She called her doctor and she was instructed to go to urgent care where they did an EKG which showed some abnormal activity. Reports she has no history of cardiac issues in the past. The doctor at urgent care recommended for her to be transported by ambulance to emergency room to rule out a pulmonary embolism. Her heart rate remained elevated and while she was in the ER she had an EKG, lab test, chest x-ray, and nuclear cat scan since she is allergic to iv contrast dye. Her cardiac enzymes were negative. She did not have a pulmonary embolism. Her d-dimer was 1,131. She confirms she was not admitted. She has an apple watch and was told to monitor her heart rate. She was instructed to call # if she experienced shortness of breath. The patient heart rate remained elevated for the next 48 hours and she did not start to feel normal and recovered completely around noon on 01Jan2021. She just had a follow up with her primary doctor. She asked if she should get the second dose of the vaccine. Her doctor consulted with the allergist and stated she should call Pfizer to ask if she should receive the second dose. Vaccination Facility Type was Nursing home where she works. No additional vaccines administered. No prior vaccinations within 4 weeks. The outcome of the events heart rate increased and dyspnoea was recovered on 01Jan2021 and unknown for the remaining event.
40 2021-01-13 palpitations, fast heart rate Patient present with anxiety, palpitations, tachycardia, dizziness and fatigue during the observatio... Read more
Patient present with anxiety, palpitations, tachycardia, dizziness and fatigue during the observation period after vaccine administration. A Rapid Response (RR) code for an anaphylactic reaction was activated. Vital signs were SPO2 100%, HR106 BPM and BP 150/100 mmHg. Patient received Epinephrine 0.3mg IM, Benadryl 50mg IV and Solucortef 200mg IV by RR code protocol. She was transfer to the ER. After transfer vital sings were 146/106 mmHg, HR 145 BPM and 120 BPM, RR 22, O2 sat 100% and 99%.
40 2021-01-13 palpitations Systemic: Chills, Systemic: Headache, Systemic: dizziness, bitterness in taste in mouth, shaky, hand... Read more
Systemic: Chills, Systemic: Headache, Systemic: dizziness, bitterness in taste in mouth, shaky, hands cold to touch, high heart rate - 120, BP 154/89
40 2021-01-13 fast heart rate Systemic: Headache-Medium, Systemic: Nausea-Medium, Systemic: Vomiting-Mild, Systemic: blurred/visio... Read more
Systemic: Headache-Medium, Systemic: Nausea-Medium, Systemic: Vomiting-Mild, Systemic: blurred/vision changes, tachycardia-Medium
40 2021-01-13 chest discomfort onset 01/12/21 at approximately 1:00pm began with report of aching, muscle aches, feverish feeling w... Read more
onset 01/12/21 at approximately 1:00pm began with report of aching, muscle aches, feverish feeling with chills. Went home at that time. Later that day around 4:00pm developed worsening fever/chills, body aches, nausea. Temp reported 101.8 oral. 01/12/21 around 6:00pm developed vomiting, muscle weakness, fatigue, joint aches, knee pain. During the night reported night sweats. AM 01/13/21 reported temp of 102.5 and new onset of skin sensitivity with touch to include clothing, water with bathing and continued symptoms of all symtpoms reported above. 01/14/21 continues with muscle weakness, body aches, fatigue, chills without temp, new onset of axillary pain right arm and reported chest tightness that began on 01/13/21. Denies difficultly with breathing, just chest tightness. Symptoms are improving each day, just reports lingering today, 01/14/21.
40 2021-01-14 lightheadedness 1330-Patient relates her mouth went dry and she became dizzy. Also c/o nausea and HA .HR 72 BP 151/... Read more
1330-Patient relates her mouth went dry and she became dizzy. Also c/o nausea and HA .HR 72 BP 151/104 O2-84-94%RA. Patient c/o tingling in fingers and toes 1340-Patient to ED room 18. 1545-Patient discharged from ED with dx of Vasovagal response
40 2021-01-14 chest discomfort Anxiety; Headache; Seeing stars; Chest tightness; Hand tremor; SOB; This is a spontaneous report fro... Read more
Anxiety; Headache; Seeing stars; Chest tightness; Hand tremor; SOB; This is a spontaneous report from a contactable pharmacist. A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1284; Expiration date was not reported), intramuscularly on the left arm on 06Jan2021 (10:15) at a single dose for COVID-19 immunization at the hospital. Medical history included migraines; heart murmur with surgery; grand mal seizure that has resolved; and contrast dye allergy. Concomitant medications included sumatriptan and norethindrone [norethisterone]. The patient previously took phenytoin, iodine, terconazole, tramadol and cetirizine; and had allergies with these medications. On 06Jan2021 (10:15), the patient was seeing stars; had chest tightness; hand tremor; and shortness of breath (SOB). The patient was referred to the Urgent Care Clinic due to these events. On 06Jan2021 (12:30), at the Urgent Clare Clinic, the patient had anxiety and headache. The patient had received acetaminophen, diphenhydramine, ibuprofen and water as treatment for the events, 'seeing stars', 'chest tightness', 'hand tremor' and 'shortness of breath'; and was provided with education on managing anxiety. The outcome of the events was recovered in Jan2021 for 'seeing stars', 'chest tightness', 'hand tremor' and 'shortness of breath'; and was unknown for 'headache' and 'anxiety'. The patient did not have COVID-19 prior to vaccination, and was not tested post-vaccination.
40 2021-01-14 chest discomfort, fast heart rate Chest tightness, Difficulty in breathing, Tachycardia, Throat tingling and burning.
40 2021-01-14 palpitations, heart rate increased Heart palp. started about hour after inj. BP was up and down. Pulse was very high. Tired, stomach c... Read more
Heart palp. started about hour after inj. BP was up and down. Pulse was very high. Tired, stomach cramps.
40 2021-01-14 fainting Patient had regular soreness, redness of injection site. Fever, chills, fatigue hours after vaccine.... Read more
Patient had regular soreness, redness of injection site. Fever, chills, fatigue hours after vaccine. Patient experienced syncope the morning after vaccination for about 15 minutes. Having bruised head and left eye.
40 2021-01-14 heart rate increased Rash on left forearm/itching/throat itching/ heart rate fast/left hand itching
40 2021-01-14 fainting partial complex seizure; I lost muscle tone and collapsed; severe LUE weakness; severe pain; aura; I... Read more
partial complex seizure; I lost muscle tone and collapsed; severe LUE weakness; severe pain; aura; I lost muscle tone and collapsed; This is a spontaneous report from a contactable other health care professional (HCP) reporting for herself. A 40-year-old female not pregnant patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the Left arm on 30Dec2020 h 05:00 PM at single dose for COVID-19 immunisation, lot number: EH9899. Patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Medical history included epilepsy (well controlled with medications) and she was allergic to phenytoin (DILANTIN). Concomitant medications in two weeks prior to the vaccination included carbamazepine, lamotrigine (LAMICTAL) and fluoxetine. It was reported that on 31Dec2020 h 14:00 (also reported as approximately 22 hours after vaccine) patient experienced severe left upper extremity (LUE) weakness and severe pain. She then experienced an aura and had a partial complex seizure. Patient lost muscle tone and collapsed. The episode lasted approximately 1.5 minutes, no treatment was given. Patient was tested for Covid post vaccination, she underwent Covid-19 PCR Test (Nasal Swab) on 04Jan2021 and on 07Jan2021, both with negative results. She also underwent a Covid-19 PCR Test on unknown unknown date in Jan2021 with unknown results. Patient recovered on 31Dec2020 from the events.; Sender's Comments: There is not a reasonable possibility that the reported events were related to the suspect product event most likely due to patient underlying contributory factors. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators as appropriate.
40 2021-01-17 chest discomfort 1/7/2021 - NAUSEA, LEG PAIN, CHILLS, FEVER (100); 1/8/2021 - CHEST TIGHTNESS; VA HOSPITAL ED @3PM. G... Read more
1/7/2021 - NAUSEA, LEG PAIN, CHILLS, FEVER (100); 1/8/2021 - CHEST TIGHTNESS; VA HOSPITAL ED @3PM. GOT AN EKG, XRAY, BLOOD TEST. FEVER UNTIL 8PM (101 F); BODY ACHES.
40 2021-01-17 hypotension, fast heart rate Hypotension, tachycardia, dizziness, nausea, vomiting (intermittent x 4 days), left arm pain, joint ... Read more
Hypotension, tachycardia, dizziness, nausea, vomiting (intermittent x 4 days), left arm pain, joint pain, chills, low grade temperature, diaphoresis, lethargy confusion (day 1 only) headache- symptoms last 4 days with height at 24-48 hours
40 2021-01-17 chest discomfort Patient stated she had chest heaviness and SOB the evening after receiving the vaccine. She saw her... Read more
Patient stated she had chest heaviness and SOB the evening after receiving the vaccine. She saw her PCP and got a steroid shot and took Benadryl on 1/15. On 1/17 she came to the ER with complaints of cough and chest heaviness thought to be caused by the vaccine. She was treated for underlying pneumonia with azithromycin 500mg PO, cefdinir 300mg PO, and a one time dose of methylprednisolone 125mg IM.
40 2021-01-17 loss of consciousness employee reports LOC for approx. 10-15seconds witnessed by family member who states her eyes rolled ... Read more
employee reports LOC for approx. 10-15seconds witnessed by family member who states her eyes rolled back and she began to drool. she has a history of passing out when not feeling well or vaccine. Eval in ED, treated with benadryl IV and fluids. D/c home.
40 2021-01-18 heart rate increased 3.5 hours after injection all of a sudden HR was at 161; Muscle pain around injection site and some ... Read more
3.5 hours after injection all of a sudden HR was at 161; Muscle pain around injection site and some fatigue, but not bad.; Muscle pain around injection site; Muscle pain around injection site and some fatigue, but not bad.; I was warmflush feeling; When HR jumped to 161 she had a weird sensation run down both of arms; This is a spontaneous report from a contactable consumer. This 40-year-old female (no pregnant) patient received first dose of BNT162B2 (lot# EL3249) on 08Jan2021 02:30 PM on arm Left for COVID-19 immunization. Medical history was Type 1 IDDM (Diabetes), Anxiety/Panic Disorder. Concomitant drug included desvenlafaxine succinate (PRISTIQ), Clonazepam, insulin lispro (HUMALOG), cetirizine hydrochloride (ZYRTEC), all received within 2 weeks of vaccination. Past drug was Allergies to levofloxacin (LEVAQUIN). It was reported that 3.5 hours after injection (08Jan2021 06:00 PM) all of a sudden HR was at 161, patient layed down and it came down a little to 115-125, for 4-5 thereafter it stayed around 110-115, and after about 6 hours it returned to normal. She was warm flush feeling but without a fever. When HR jumped to 161 she had a weird sensation run down both of arms but is subsided with kaying down and HR coming down a bit. No toher bad issues since. Muscle pain around injection site and some fatigue, but not bad. Emergency room/department or urgent care visit. Treatment: EKG, CXR, Labwork, very brief monitoring of HR/BP. Outcome of the event was recovered. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No follow-up attempts are needed. No further information is expected.
40 2021-01-18 chest pain Back pain, headache, joint pain, weakness, fever, chest pain.
40 2021-01-18 pallor During the Covid vaccine observation period the patient complained of hoarseness, itching and throat... Read more
During the Covid vaccine observation period the patient complained of hoarseness, itching and throat swelling. The patient had history of chronic urticaria and prior to receiving her vaccine had taken benadryl, ranitidine as well as an OTC antihistamine at home. She was escorted via wheelchair to the ED, BP 151/102 and pulse 101 in ED, pt noted to have blanching hive-like rash on her chest as well. Received Epinephrine 0.3mg, prednisone 60mg PO x 1. Pt was monitored for 3 hours and discharged to home.
40 2021-01-18 palpitations Lightheaded, felt like passing out, intermittent palpitations
40 2021-01-18 chest discomfort Reported chest tightness.
40 2021-01-18 blood pressure increased Within 6 minutes I had a metalic taste in my mouth, the roof of my mouth went numb, my tongue starte... Read more
Within 6 minutes I had a metalic taste in my mouth, the roof of my mouth went numb, my tongue started to swell up, the inside of my mouth started to swell up. I lost sense of taste to even water. I was allowed to take my 50 mg of benedryl. My BP was 171/100. I was taken to the ED and that is where I received the vaccine as well.
40 2021-01-18 chest pain patient began to experience chest pain (6 on 10 scale) 10 minutes after administration. no other as... Read more
patient began to experience chest pain (6 on 10 scale) 10 minutes after administration. no other associated symptoms. Vital signs normal. Evaluated in Emergency Dept. Discharged. Note that patient was very anxious prior to and after vaccination.
40 2021-01-19 chest pain Hypertensive Emergency (BP 219/114) with no previous blood pressure issues; Radiating chest pain, le... Read more
Hypertensive Emergency (BP 219/114) with no previous blood pressure issues; Radiating chest pain, left arm pain; jaw pain; This is a spontaneous report from a contactable other Health Professional (patient). A 40-year-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EX5170), via an unspecified route of administration on 16Dec2020 15:00 at single dose in left arm for covid-19 immunization. Medical history included symptomatic PVC's (Premature ventricular contractions), tachycardia, bradycardia, CVA (cerebrovascular accident) from 2018 to an unknown date, asthma and rhythm. Concomitant medication included flecainide, spironolactone, metoprolol for rhythm. The patient had known allergies included hydrocodone bitartrate, paracetamol (VICODIN), eletriptan and adhesive. Prior vaccination, the patient had no covid. On 22Dec2020 18:00, the patient experienced hypertensive Emergency (BP 219/114) with no previous blood pressure issues. Radiating chest pain, left arm pain, and jaw pain. Admitted to the hospital where an echocardiogram and angiogram was performed showing clear coronary arteries and no hypertensive remodeling of the heart. Issue has been ongoing since, despite interventions. The events result in emergency room/department or urgent care and hospitalization from an unspecified date for 1 day. The patient received the treatment for the events included frequent nitroglycerin, hydralazine and metoprolol. The patient underwent curative-SARS-Cov-2 Assay RT-PCR on 01Jan2021 with negative result. The outcome of the events was not recovered.; Sender's Comments: Based on the information available, contributory role of BNT162B2 ((PFIZER-BIONTECH COVID-19 VACCINE,) to event "hypertensive emergency (BP 219/114) with no previous blood pressure issues" cannot be excluded. The events chest pain and pain in jaw are attributed to underlying medical conditions and assessed unrelated. BNT162B2 ((PFIZER-BIONTECH COVID-19 VACCINE,). The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
40 2021-01-19 chest discomfort, palpitations Patient presented for evaluation of an episode of chest tightness and possible allergic reaction aft... Read more
Patient presented for evaluation of an episode of chest tightness and possible allergic reaction after receiving the Pfizer vaccination for COVID-19. Patient reports that she initially did well but while she was waiting the 15 minutes of observation after the vaccine she began to note intermittent chest tightness as well as feeling like her heart was racing. This may have represented an allergic reaction although she did not require any medication to treat it.
40 2021-01-19 chest discomfort, chest pain Severe pain in left arm (still in pain 1/20), unable to move arms above head (lasted 5 days for both... Read more
Severe pain in left arm (still in pain 1/20), unable to move arms above head (lasted 5 days for both arms), Chest pain and squeezing sensation in chest and both arms (lasted 6 days), altered heart rate (lasted 2 days), internal swelling (was told this is what was causing the "squeezing" sensation)
40 2021-01-20 blood pressure increased 2nd vaccine dose administered on 08Jan, with a new increase of blood pressure; 2nd vaccine dose admi... Read more
2nd vaccine dose administered on 08Jan, with a new increase of blood pressure; 2nd vaccine dose administered on 08Jan, with a new increase of blood pressure; This is spontaneous report from a contactable Other Healthcare Professional (patient). A 40-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot number: unknown, via an unspecified route of administration on 08Jan2021 at single dose for COVID-19 immunisation. Medical history included Symptomatic PVC's, Tachycardia, Bradycardia, CVA (Cerebrovascular accident) in 2018, Asthma, adhesive allergy, rhythm. Concomitant medication included flecainide, metoprolol for rhythm, spironolactone. The patient previously took hydrocodone bitartrate, paracetamol (VICODIN), eletriptan and experienced drug allergy; received the first dose of BNT162B2 on 16Dec2020 03:00 PM in Left arm for COVID-19 immunisation, and experienced Hypertensive Emergency (BP 219/114) with no previous blood pressure issues, radiating chest pain, left arm pain, and jaw pain on 22Dec2020, admitted to the hospital. The patient received the 2nd vaccine dose administered on 08Jan2021, with a new increase of blood pressure. The patient underwent lab tests and procedures which included blood pressure measurement: new increase of blood pressure on an unspecified date; blood pressure 219/114 on 22Dec2020; Curative-SARS-Cov-2 Assay RT-PCR: negative on 01Jan2021. The outcome of the event was not recovered. Information on the Lot/Batch number has been requested.
40 2021-01-20 chest pain Employee reported flushing, itching and burning sensation noted to her cheeks, nose, chin, and chest... Read more
Employee reported flushing, itching and burning sensation noted to her cheeks, nose, chin, and chest within hours of receiving 2nd dose of vaccine. She stated that she has continued experiencing it intermittently, has taken Benadryl at night time, and is planning on trying Zyrtec.
40 2021-01-20 fast heart rate, fast heart rate, fast heart rate My left arm was sore with any movement for almost 48 hours. The afternoon after my vaccine I didn't... Read more
My left arm was sore with any movement for almost 48 hours. The afternoon after my vaccine I didn't feel great then I developed tachycardia, dry heaves and broke into a cold sweat. The event lasted between 1.5-2 hours.
40 2021-01-21 heart rate irregular, heart rate decreased, heart rate increased After her 15 minute post-vaccination waiting period, noticed her smart watch indicated a high heart ... Read more
After her 15 minute post-vaccination waiting period, noticed her smart watch indicated a high heart rate (approximately 180). She sat back down for a few minutes and her heart rate slowly decreased. However, when she collected her belongings and began to walk , she noticed that her heart rate increased again and she felt dizzy. She stopped by a clinic within the hospital to have her heart rate checked on a pulse oximeter. It was reading about 130, but varied from 109 up to 140's/150's. She then called her doctor who encouraged her to contact the clinic. She does not feel unwell while at rest but did have dizziness when walking. After visiting with Dr she was escorted to the Emergency Department for evaluation.
40 2021-01-22 chest discomfort 1/19 arm sore 1/20 achy 1/22 tightness in chest
40 2021-01-22 palpitations Heart palpitations Chills Freezing hands Chills Stomach pain Body aches Headaches Loss of focus Weak... Read more
Heart palpitations Chills Freezing hands Chills Stomach pain Body aches Headaches Loss of focus Weak Lightheadedness Dizzy Loss of balance Tingling in lips Swollen throat
40 2021-01-23 oxygen saturation decreased Fever, headache, chills, cough, congestion, lower oxygen levels, fatigue
40 2021-01-23 palpitations Pfizer vaccine given @ 0956. After vaccine administration, client drove her car to the recovery area... Read more
Pfizer vaccine given @ 0956. After vaccine administration, client drove her car to the recovery area and met with the nurse, to show her direction of where to wait for recovery. client informed her, "I think I'm having an allergic reaction." Nurse asked her to describe what symptoms she is having. Client stated that she had an itchy throat, she felt that she couldn't breathe, and her heart was racing. Nurse activated RRT. At 10:00, Nurse responded to scene with the Kit containing the AED, oxygen, and emergency medication. Vitals taken: P: 102, RR: 18, Manual BP: 120/80, Oxygen: 100% RA, no pain. Upon assessment, stethoscope used, clear lungs sounds, normal heart sounds. Client AAO x4, speaking in full sentences, no SOB noted. Skin color normal, capillary refill <3 seconds. Lip color normal. Nurse noted that client's lymph nodes were swollen. Throughout event, client spoke with no SOB and in clear sentences. EMS arrived to scene at 10:09 am. Vitals: HR: 99, 100% RA, 146/98. At this point, client is reporting feeling much better, head-to-toe assessment appears normal. She refused transport via ambulance to the hospital. EMS left scene at 10:20 am. Client was instructed to wait for 30 more minutes for monitoring. Client left scene at 10:30 am with client feeling better. Lymph nodes are no longer swollen, client continues to speak in full sentences with no SOB noted. Skin and lip color normal. Client AA0x4. Client instructed that if she is needing medical attention, feeling SOB, etc., to call 911 or go to the nearest hospital.
40 2021-01-24 chest discomfort, blood pressure increased, loss of consciousness, heart rate increased Itching; headache and body aches; headache and body aches; chest tightness; had hives; Vertigo; Nyst... Read more
Itching; headache and body aches; headache and body aches; chest tightness; had hives; Vertigo; Nystagmus in her eyes; passing out; vomiting/puke when vertical; Dizziness; tingling and numbness in throat and lips; tingling and numbness in throat and lips; tingling and numbness in throat and lips; tingling and numbness in throat and lips; heart rate 125; BP of 170/100; throat tightness; This is a spontaneous report from a contactable consumer (patient). A 40-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=El1283) via an unspecified route of administration at left arm on 08Jan2021 11:30 at single dose for covid-19 immunization. Vaccine was administered at hospital. Medical history included ongoing autoimmune disorder. The patient had known allergies to Amoxicillin and wasps. No family medical history relevant to events. Ongoing concomitant medication included hydroxychloroquine sulfate (HYDROXYCHLOROQUINE) for autoimmune disorder, celecoxib (CELEBREX) for autoimmune disorder, oral dimenhydrinate (DRAMAMINE), oral fexofenadine hydrochloride (ALLEGRA) and oral famotidine (PEPCID). No other vaccine in four weeks. The patient previously took flu vaccine (Expiry Date: Nov2020), tetanus vaccines for immunization. At 11:40 on 08Jan2021, the patient had tingling and numbness in throat and lips, heart rate was 125. By noon had hives and blood pressure (BP) of 170/100 (normal BP was 96/58 and heart rate was 65), chest tightness and throat tightness, the patient was given Benadryl (50mg) and monitored. No change so walked to emergency room. Given intravenous Benadryl and steroids then released the same day on 08Jan2021. The patient woke up on Saturday and shortly after hives came back, itching, chest tightness, headache and body aches. Saturday night on 09Jan2021 she went back to hospital due to continued reaction from 09Jan2021 06:00 pm until 10Jan2021 04:30 PM. The patient was admitted for heart testing then released on Sunday afternoon simply due because each doctor said they didn't know what to do. The patient slept from late Saturday night to Monday (except testing and eating at hospital), on 11Jan2021 around noon the patient took a shower and hives, itching and tingling all came back. Completely started over with reaction and started dizziness. On Tuesday 12Jan2021, primary care physician (PCP) for tests. Chest tightness started subsiding but very dizzy, puke when vertical. Wednesday: rheumatoid doctor. The patient had extreme vertigo. Other reported events: passing out, vomiting. Nystagmus in her eyes was very strong so that she got very dizzy. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care or Hospitalization. Adverse event start time also reported as 11:45 am. The patient underwent lab tests and procedures which included blood pressure 170/100 on 08Jan2021, blood test and electrocardiogram (EKG) with unknown results, heart rate: 125 on 08Jan2021. Normal BP was 96/58 and heart rate was 65. Heart and lungs examination with clear result. The patient had no Covid prior vaccination. Nasal Swab of Covid tested post vaccination on 05Jan2021 with a result of negative. Heart rate 125 recovered on 12Jan2021. BP of 170/100 recovered on 12Jan2021. Chest tightness sometimes she has episodes. She cannot walk without assistance. She stated she currently was 100% dependent on someone else. Throat tightness recovered on 11Jan2021. Outcome of other events was not recovered. She was treated at hospital with Oral and IV Benadryl and IV Steroids on 08Jan2021. On 09Jan2021 she was administered Oral Prednisone, Oral Diphenhydramine HCl (BENADRYL) and Oral Acetaminophen(Tylenol). Steroids switched from prednisone Oral to dexamethasone Oral twice daily. On 13Jan2021 she started on ondansetron (ZOFRAN) 4mg 3xday Promethazine (Fenagrin) 25 mg once at night. Information on Lot/Batch has been requested.
40 2021-01-24 lightheadedness Pfizer-BioNTech COVID-19 Vaccine EUA: Two days after receiving vaccination patient presents to the e... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA: Two days after receiving vaccination patient presents to the emegency department for a near syncopal episode. Since vaccination patient reports fever (up to 101 degrees Fahrenheit), chills, light headedness, headache, and myalgias. In the emergency department vitals stable and within normal ranges including temperature 36.5 degrees Celsius. No rash, hives, or shortness of breath noted or reported. Patient adminsitered fluids with symptom improvement. Discharged to home stable.
40 2021-01-24 lightheadedness Pfizer-BioNTech COVID-19 Vaccine EUA: Two days after receiving vaccination patient presents to the e... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA: Two days after receiving vaccination patient presents to the emergency department for a near syncopal episode. Since vaccination patient reports fever (up to 101 degrees Fahrenheit), chills, hight headedness, headhache, and myalgias. In the emergency department vitals stable and within normal ranges, including temperature 36.5 degrees Celsius. No rash, hives, or shortness of breath noted. Patient administered intravenous fluids with symptom improvement. Discharged home stable.
40 2021-01-25 heart rate increased Face numbness; Headache; Fatigue; Legs aching; Muscle soreness in the left arm; Rapid heartbeat; Thi... Read more
Face numbness; Headache; Fatigue; Legs aching; Muscle soreness in the left arm; Rapid heartbeat; This is a spontaneous report from a contactable health care patient. This 40-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 11Jan2021 at single dose for COVID-19 immunisation. Vaccine location was left arm. Medical history included frequent migraines, anxiety and anemia. Historical vaccine included first dose of BNT162B2 (Lot # 1), intramuscular left arm, on 21Dec2020 at 07:30 AM for COVID-19 immunisation. Age at vaccination was 40-years-old for both doses. Concomitant medications included topiramate (TOPAMAX), ascorbic acid, cyanocobalamin, ergocalciferol, nicotinamide, pyridoxine hydrochloride, retinol, riboflavin, thiamine mononitrate (ONE DAY VITAMINS), phentermine, phendimetrazine tartrate (BONTRIL), naproxen sodium (ALEVE), escitalopram. On 11Jan2021 at 12:00 PM, the patient experienced face numbness, headache, fatigue, legs aching, muscle soreness in the left arm, and rapid heartbeat. No treatment was received for the event. Outcome was recovering. Information on the lot/batch number has been requested.
40 2021-01-25 chest pain I received the 2nd dose of the vaccine on Monday 1/4/2021 at 1600. Over the afternoon and evening I ... Read more
I received the 2nd dose of the vaccine on Monday 1/4/2021 at 1600. Over the afternoon and evening I developed arm pain at the injection site. Since there were no other side effects in the morning, I returned to work for my regularly scheduled shift on 01/05/2021 at 0545. At approximately 0615 I began to get body aches and restlessness. At approximately 0725 in addition to the body aches and restlessness, I began to get severe nausea, weakness, light-headedness, headache, profuse sweating, and severe chest pain and shortness of breath. Because of the severity of my symptoms my manager immediately told me to go to the ED and a fellow co-worked brought me down via wheelchair. In the emergency department I was assessed and worked up and after several tests and xrays I was given a diagnosis of adverse reaction to drug/vaccine. I was discharged to home at approximately 1130 on 01/05/2021. Upon arriving home I continued to have body aches, and then developed chills, shaking and fever of 101.00. All of this combined became unbearable and I had to take 500mg of Tylenol at 2230 on 01/05/2021. On 01/06/2021 I still felt horrible with body aches, fever, nausea and fatigue. My weakness, fatigue are still present today 01/07/2021 at 0945.
40 2021-01-25 fast heart rate Left axillary swelling; tachycardia; shortness of breath; fever; chills; muscle aches; joint pain; T... Read more
Left axillary swelling; tachycardia; shortness of breath; fever; chills; muscle aches; joint pain; This is a spontaneous report from a contactable other healthcare professional (patient). A 40-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration (left arm) on 10Jan2021 18:00 at single dose for Covid-19 immunization. The patient received the first dose of BNT162B2 (lot number: EK5730) via an unspecified route of administration (left arm) on 20Dec2020 (04:00 PM) for Covid-19 immunization. Medical history included known allergies to latex, cinnamon, and nickel. Concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced left axillary swelling, tachycardia, shortness of breath, fever, chills, muscle aches, and joint pain on 10Jan2021 (19:00). The events resulted in Doctor or other healthcare professional office/clinic visit. No treatment was received for the adverse events. The outcome of events was not recovered. The patient has not been tested for COVID-19 post vaccination.
40 2021-01-25 chest pain Rashes to upper body anterior and posterior; Generalized body pain; chest pain; This is a spontaneou... Read more
Rashes to upper body anterior and posterior; Generalized body pain; chest pain; This is a spontaneous report from a contactable Nurse (patient). A 40-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EK5730), intramuscularly in left arm on 01Jan2021 06:15 at single dose for COVID-19 immunization. Medical history was none. Known allergies: No. Other medical history: No. The patient was not pregnant. Concomitant medication in two weeks included colecalciferol (VITAMIN D). If other vaccine in four weeks: No. The patient experienced rashes to upper body anterior and posterior, generalized body pain, chest pain, all on 12Jan2021 17:00 with outcome of not recovered. No treatment received for the events. If covid prior vaccination: No. If covid tested post vaccination: No. AE was not resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.
40 2021-01-25 fast heart rate fever 101; moderate headache; tachycardia at rest; This is a spontaneous report from a contactable n... Read more
fever 101; moderate headache; tachycardia at rest; This is a spontaneous report from a contactable nurse reporting for herself. A 40-year-old female patient received the second dose of bnt162b2 (BNT162B2, lot number: EL1287, expiry date: not reported), via an unspecified route of administration, on 12Jan2021 04:15 PM at a single dose on the left arm for COVID-19 immunization. The patient was not pregnant. She received the vaccine at a workplace clinic. She had not received any other vaccines in four weeks. Medical history included arthritis. The patient had no known allergies. Concomitant medications included paracetamol (TYLENOL), multivitamin, and airborne immune supplement; these are the other medications she took in two weeks. The patient previously received the first dose of bnt162b2 (BNT162B2, lot number: EL1284, expiry date: not reported), via an unspecified route of administration, on 23Dec2020 04:45 PM at a single dose on the left arm for COVID-19 immunization. On 13Jan2021 03:00 AM, within 12 hours of 2nd vaccine dose, the patient experienced fever 101, moderate headache, tachycardia at rest. The patient was not diagnosed with COVID prior to vaccination and had not tested for COVID post vaccination. The patient received no treatment for the reported adverse events. Outcome of the events was recovering.
40 2021-01-26 hypotension After receiving vaccine developed dizziness and hypotension, then developed itchiness in throat. EP... Read more
After receiving vaccine developed dizziness and hypotension, then developed itchiness in throat. EPI pen was administered and emergency response team called. She was transported to the Emergency Room for treatment. She was treated with steroids and antihistamines. Diagnosed with anaphylactic reaction. Discharged with EpiPen, albuterol inhaler prn, and steroid taper.
40 2021-01-26 fainting Around 10 minutes after injection, she developed symptoms that included nausea, dizziness, and sync... Read more
Around 10 minutes after injection, she developed symptoms that included nausea, dizziness, and syncope. Symptoms progressed over time until she seemed almost catatonic at times including delayed responses, staring straight ahead (later she closed her eyes), slurred speech. She kept repeating, "I feel like jelly" and that she was very tired. Pharmacist gave her 25 mg diphenhydramine at 10:55 am. Around 11:10 the facilities administer called 911 at the request of (PharmD).
40 2021-01-26 fast heart rate Myalgias, rigors and chills starting at 2:00am on 1/24/2021 Fever (101.5), rigors, severe myalgias, ... Read more
Myalgias, rigors and chills starting at 2:00am on 1/24/2021 Fever (101.5), rigors, severe myalgias, tachycardia, dyspnea at 12:00pm 1/24/2020 Improvement with ibuprofen and acetaminophen. Resolved by 1/25/2021
40 2021-01-26 heart rate increased Pulse started racing; I felt dizzy; Short of breath; Anxious; This is a spontaneous report from a co... Read more
Pulse started racing; I felt dizzy; Short of breath; Anxious; This is a spontaneous report from a contactable consumer (patient). A 40-year-old non-pregnant female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID 19 VACCINE; unknown lot number and expiration date), via an unspecified route of administration left arm on 31Dec2020 11:30 at a single dose for covid-19 immunization. The patient has no medical history. The patient was not diagnosed with Covid prior to vaccination. The patient has no known allergies. Concomitant medication includes vitamins NOS (MULTIVITAMIN). The patient did not receive other vaccines in the last four weeks. The patient received the vaccine in a facility. About 5 minutes after (31Dec2020 11:35 AM) the patient received the vaccine, the patient's pulse started racing, and she felt dizzy, short of breath and anxious. The adverse events result in a doctor or other healthcare professional office/clinic visit. No treatment was received for the adverse events. The patient has not been Covid tested post vaccination. The outcome of the events was recovered on an unspecified date. The following information on the batch/lot number has been requested.
40 2021-01-26 chest discomfort Tightness in chest, chest congestion without cough , or fever. Need not seek medical attention .
40 2021-01-26 chest pain, chest discomfort body aches; chills; severe headache/Extreme headache; chest discomfort/chest pain/heaviness/Feels li... Read more
body aches; chills; severe headache/Extreme headache; chest discomfort/chest pain/heaviness/Feels like something is heavy on my chest; chest discomfort/chest pain/heaviness/Feels like something is heavy on my chest; extremely tired; not able to carry out daily activities; This is a spontaneous report from a contactable other health care professional. A 40-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 11Jan2021 07:45 at SINGLE DOSE at left arm for COVID-19 immunization. Medical history reported as none. The patient has no known allergies. The patient received first dose of COVID19 vaccine BNT162B2 on 24Dec2020 11:45PM at left arm. There were no concomitant medications. The patient stated, On 11Jan2021 16:00, "I'm having body aches, chills, severe headache/extreme headache and chest discomfort/chest pain. I understand that the body is trying to build an immune response and I understand that body aches and chills are part of that but I don't get headaches, ever, and I have never had chest discomfort or heaviness like this so how is that an immune response. I want you to tell me why I feel this way." It was also reported that the patient was extremely tired, and not able to carry out daily activities. The patient did not receive treatment for the events. The outcome of the events was not recovered. AE resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Information about batch/lot number has been requested.
40 2021-01-26 palpitations heart palpitations; Stated that it felt like nerves on inside of her body were reacting like bugs cr... Read more
heart palpitations; Stated that it felt like nerves on inside of her body were reacting like bugs crawling on the inside of her skin; bad headache; Sore throat; tongue swollen; tired; weak; This is a spontaneous report from a contactable consumer reported for self. This 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via Intramuscular on 12Jan2021 on Arm Left at single dose (lot: EK9231) for covid-19 immunisation. Med history and concomitant medications were none. The patient had injection done yesterday (12Jan2021) and wanted to report symptoms. Stated that it felt like nerves on inside of her body were reacting like bugs crawling on inside of her skin 12Jan2021 at 6:30pm which calmed down at 10:00pm, bad headache 12Jan2021 at 6:30pm, sore throat, tongue felt swollen happened on 12Jan2021 after the injection, both resolved at 10:30pm. Stated that she did do Benadryl. Stated that she took another Benadryl this morning and it feels like it is wearing off and the sensation is coming back. Stated felt tired and weak on 12Jan2021. Stated felt like having palpitations and heart going too fast on 13Jan2021. Stated that she called her primary healthcare provider and was told to call Pfizer. Wanted to know if she needed to go to her doctor. Outcome of the events sore throat, tongue felt swollen was recovered 12Jan2021 10:30pm. Outcome of other events was not recovered.
40 2021-01-27 palpitations Fever since evening of the injection, continuous headache, muscle aches, unable to work today, palpi... Read more
Fever since evening of the injection, continuous headache, muscle aches, unable to work today, palpitations, general malaise.
40 2021-01-27 loss of consciousness Patient is a healthcare worker who received the first dose of the COVID-19 vaccine. Later that day,... Read more
Patient is a healthcare worker who received the first dose of the COVID-19 vaccine. Later that day, patient had excessive fatigue and some site injection pain. The next morning patient has loss of consciousness witnessed by husband. At the same time patient was drooling, not speaking clearly, and then eyes rolled back in her head, and passed out for a few minutes.
40 2021-01-27 heart rate increased Went to hospital in middle of night when resting heart rate was 136/ woke up in middle of night with... Read more
Went to hospital in middle of night when resting heart rate was 136/ woke up in middle of night with racing heart/was 133; chills; fever; body aches; swollen axillary lymph nodes; rash on shoulder, armpit and back close to the vaccine site; bad headache; This is a spontaneous report from a contactable nurse. A 40-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular (left arm) from 13Jan2021 10:45 to 13Jan2021 10:45 at a single dose for covid-19 immunization. Medical history included asthma and hypothyroidism. Concomitant medication included beclometasone dipropionate (QVAR) and levothyroxine. The patient also has allergies to Codeine and Azithromycin. The patient took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 23Dec2020. Information on the lot/batch number has been requested. It was reported that the patient went to the hospital (Emergency Room/Urgent Care) in the middle of the night when her resting heart rate was 136 on 13Jan2021. She had fever, chills, body aches. She woke up in the middle of the night with racing heart. Was 133 in the hospital, they gave her 2 liters of fluids which eventually brought it down to 105. They ran a lot of test and ruled out anything else. On Jan2021, they also found swollen axillary lymph nodes. It's now 48 hours later, still have a fever, HR finally is below 100, she now has a rash on her shoulder, armpit and back close to the vaccine site and she have a bad headache. The outcome of the event fever was not recovered while recovered with sequel on unspecified dates for the other events.
40 2021-01-27 hypotension weakness; confusion; dizziness; headache; hypotension; diarrhea; fatigue/lethargy; fatigue/lethargy;... Read more
weakness; confusion; dizziness; headache; hypotension; diarrhea; fatigue/lethargy; fatigue/lethargy; nausea; unilateral pain; photophobia x 3 days; Vomiting; This is a spontaneous report from a non-contactable Other HCP (patient). This 40-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 14Jan2021 at single dose for COVID-19 immunisation. Vaccine location was left arm. The patient was vaccinated at hospital, age at vaccination was 40-years-old. No other vaccine was received in four weeks. Medical history included migraines, IgM, and MGUS. Historical vaccine included first dose of BNT162B2 in left arm for COVID-19 immunisation. Concomitant medications included fremanezumab (AJOVY), escitalopram oxalate (LEXAPRO), and NURTEC (as reported). On 14Jan2021, the patient experienced vomiting, nausea, hypotension, weakness, unilateral pain and weakness, dizziness, confusion, headache, fatigue/lethargy, diarrhea, photophobia x 3 days. Events were recovering. No treatment was received for the event. No follow up attempts are possible; information about lot/batch number cannot be obtained.
40 2021-01-28 blood pressure increased Approximately 15 minutes after vaccine patient began feeling flushed, but denied any rash or respira... Read more
Approximately 15 minutes after vaccine patient began feeling flushed, but denied any rash or respiratory issues. Patient chose to leave facility and went to a store where she purchased Benadryl and took 25mg orally. Patient returned to site where vaccine was given (which is also her place of employment). Nurse evaluated patient and rash noted on chest. Blood pressure elevated to 220/115 and heart rate 120. Physician evaluated patient. EKG performed and patient found to have sinus tachycardia. Benadryl 25mg and Kenalog 40mg administered intramuscularly. Blood pressure came down to 150/104 which patient reported was close to her recent baseline as she recently had a medication adjustment. After approximately 15 minutes patient no longer felt flushed. Patient was instructed to take and additional dose of Benadryl 50mg orally that evening and a Prednisone dose pack was prescribed.
40 2021-01-28 heart rate increased Arm and face swelling, fever, bloodshot eyes, rapid heart rate, body pain, nausea, and headache. Too... Read more
Arm and face swelling, fever, bloodshot eyes, rapid heart rate, body pain, nausea, and headache. Took Tylenol, fluids, Benadryl, and rest.
40 2021-01-28 loss of consciousness patient felt lightheaded within 30 minutes after vaccine, then about 6 hours later she passed out an... Read more
patient felt lightheaded within 30 minutes after vaccine, then about 6 hours later she passed out and had to go to the hospital; she was treated with IV fluids, meclizine, and ativan
40 2021-01-31 heart rate increased I had a rapid heart beat and a headache that wouldn't go away for two days!
40 2021-01-31 fast heart rate Pt received first dose and stated feeling throat swelling. Monitors with vitals and called Allergy. ... Read more
Pt received first dose and stated feeling throat swelling. Monitors with vitals and called Allergy. BP WNL, Tachycardic to 106. No signs of facial edema, no difficulty breathing or swallowing, Allergy recommended to give 10mg of Zyrtec. Afterward developed tingling in mouth. Observed total of 1hr. No progression of symptoms and allowed to go home.
40 2021-01-31 chest discomfort chest discomfort/something heavy on her chest; cannot even get out of bed; cannot cook right/ cannot... Read more
chest discomfort/something heavy on her chest; cannot even get out of bed; cannot cook right/ cannot do her daily duties/ could not even put her seat belt or roll up the window in her car; extreme headache; received first dose of the vaccine on 24Dec2020/the second dose on 11Jan2021; Chills; feeling horrible/feels foggy; feeling tired/ exhausted; body aches; arm was really sore; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date not provided), intramuscularly on 11Jan2021 07:45 at single dose in left arm to prevent covid, since she worked in a hospital with covid patients. Medical history provided as none. There were no concomitant medications. She gets the flu vaccine annually. The patient previously received first dose of BNT162B2 vaccine intramuscularly on 24Dec2020 23:45 in left arm for COVID-19 immunization with no adverse events. There were no other prior Vaccinations within 4 weeks. The patient experienced chills on 11Jan2021, feeling horrible on 11Jan2021, extreme headache on 12Jan2021, chest discomfort/something heavy on her chest on 13Jan2021, feeling tired/ exhausted on 11Jan2021, chest discomfort, feeling tired/ exhausted was reported as worsened; body aches on 11Jan2021, feels foggy on 13Jan2021, arm was really sore on an unspecified date in Jan2021, cannot even get out of bed on 12Jan2021. Specifically, it was reported that the patient worked 12 hours overnight, she slept and when she woke up she felt chills and felt horrible. States it carried on 12Jan2021. Today on 13Jan2021 she has an extreme headache, she clarifies the headache started on 12Jan2021 (yesterday). She feels like something heavy on her chest, chest discomfort. She has body aches and feels tired. She cannot cook right, she is so exhausted and cannot do her daily duties. She is assuming it is the immune reaction. Her son told her she looks really sick. States she rarely gets sick and when she gets sick she does get chills. Her chest feels like something is heavy on her. States if she did not have a strong heart, she cannot imagine what someone that does not have a strong heart would feel like. Since she works in a hospital she deals with covid all year around and she has been strong and healthy this year. Reports her headache is strong and today on 13Jan2021 she feels foggy. States yesterday on 12Jan2021, she was horrible and today (13Jan2021) is better in regards to chills. Her arm was really sore and now her arm is better, she could not even put her seat belt on 12Jan2021 (yesterday) or roll up the window in her car. She is nervous about the chest discomfort and headache. Asking where it could be coming from. She thinks it could be a possible immune response. If the chest discomfort continues she will go get seen. Advised to contact hcp. States she feels like crap. States she never gets headaches. Yesterday on 12Jan2021, her body aches were horrible and she cannot even get out of bed. The outcome of events chills, body aches was recovering, outcome of events extreme headache, chest discomfort/something heavy on her chest, feeling tired/ exhausted was not recovered, outcome of the other events was unknown. Information on the lot/batch number has been requested.
40 2021-02-01 palpitations, lightheadedness Lightheaded; intermittent palpitations; felt like passing out; This is a spontaneous report from a c... Read more
Lightheaded; intermittent palpitations; felt like passing out; This is a spontaneous report from a contactable pharmacist (patient). A 40-year-old non-pregnant female patient received her first dose of bnt162b2 (BNT162B2 reported COVID-19 VACCINE; lot number: EL3246; expiration date: unknown), intramuscular right arm on 10Jan2021 at a single dose for covid-19 immunization. Medical history allergies to seafood, milk and peanuts. The patient was not diagnosed with covid prior to vaccination. There were no concomitant medications. The patient did not receive other vaccines in the last four weeks. The patient previously took tetracycline but had allergies. The patient experienced lightheaded, felt like passing out and had intermittent palpitations on 10Jan2021. No treatment was received for the adverse event. The patient did not covid tested post vaccination. The outcome of the events was recovered on Jan2021.
40 2021-02-02 troponin increased, chest pain The patient was admitted to the hospital on 24 January with chest pain, elevated troponin, and EKG c... Read more
The patient was admitted to the hospital on 24 January with chest pain, elevated troponin, and EKG changes in the setting of a couple days of chills, sweats and malaise after receiving the covid vaccine. Initially there was concern for acute MI and he was taken for a coronary angiogram. The angiogram was clean and showed no obstructive disease. He had a cardiac MRI which showed findings consistent with myocarditis. He was treated with supportive care and eventually was discharged. He was worked up for other causes of myocarditis with none to be found.
40 2021-02-03 chest pain December 28,(before the vaccine) I was exposed to COVID at work. I started feeling feverish on Mond... Read more
December 28,(before the vaccine) I was exposed to COVID at work. I started feeling feverish on Monday at work. I needed to use my inhaler twice that day. I couldn't stop coughing at work. At home that night - used inhaler again and I had an elevated temperature - 99. something is high for me. I missed work on Tuesday. Couldn't breathe and it hurt my chest to breathe. My temp was over 100. Dr appt - went to it late afternoon he wanted me test for COVID. Took vitals - mostly normal - temp.; checked OXYGEN - normal. COVID test - was positive. Temperature went to 101 that night - couldn't breathe good - couldn't stop shaking; I was aching and I was in pain; I couldn't feel warm enough. Tried to sleep and drink fluids. Still didn't have test results from COVID test on Thursday - temp was up to 102 now. The doctor said they couldn't do anything until they had results back of test. Friday - 101 and 102.8 - temperature that day. After hours clinic - I called them - Dr - I had to gasp for every breath and I was coughing a lot. He prescribed Benzymidate - cough pearls and Azithromycin - started taking those that night. By Sunday afternoon, my fever continued and I still didn't have COVID results yet. My mom took me to Urgent Care on Sunday - still running fever; he looked at my lungs and listened - he could hear wheezing and crackling in my lungs - he determined pneumonia - he didn't know what kind - he gave me Augmentin - he told me to use both my Albuterol inhaler and steriod haler; Mucinex expectorant twice a day; Vit C and Vit D and Elderberry and Tylenol and two antibiotics. Saturday - before I went to Urgent Care on Sunday - I noticed I couldn't smell. Monday is when I got the positive test for COVID. Provided info to work and I tried to figure out how to work. Even though I was still very sick, I worked again online on Monday. But I couldn't keep working - got really whoozy; coughing and gasping felt like I was going to pass out and felt like I could hardly breathe. My mom called 911 for me. I managed to get to the bathroom - but having trouble breathing and I almost threw up - heard ringing in my ears and room was spinning. There is a lot of things after that I don't remember - when they moved me to ambulance to hospital bed I realized I had an IV in me. They stabilized me. They let me go home. I took the rest of the week off from work. Took a lot of medication and was keeping up with my vital during that week - 99.8 - 102.8 - for ten days I ran that fever. Broke Jan 20th. I went back to work on Jan 25. Still had to use an inhaler a lot. I'm slowly getting taste back; I can't taste flavor but can taste salt . I'm slowly getting smell back. I still have a lot of congestion but not as bad. Ears were bothering me this weekend so I did go to urgent care on they put me on a third antibiotic for an ear infection. Gave COVID to my son and my mother. Still have trouble catching me breath. January 23 - my isolation was extended to . the county extended my isolation period because of my family getting COVID. I'm about 75% recovered, I'd say.
40 2021-02-03 heart rate increased Elevated heart rate immediately after vaccine; shortness of breath with 90 minutes that's persisted ... Read more
Elevated heart rate immediately after vaccine; shortness of breath with 90 minutes that's persisted on and off for 5 days so far; This is a spontaneous report from a non-contactable healthcare professional reporting on behalf of the patient. A 40-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Unknown lot number and expiration), intramuscular in left arm on 15Jan2021 at 09:30 AM at a single dose for COVID-19 immunization in a hospital. Medical history included asthma. The patient has no known allergies to medications, food, or other products. Concomitant medications included antibiotics, prenatal vitamins, and probiotics. On 15Jan2021, the patient experienced elevated heart rate immediately after vaccine and shortness of breath with 90 minutes that's persisted on and off for 5 days so far. The patient received albuterol for the event. The patient did not receive other vaccines within 4 weeks prior to the COVID vaccine. The events resulted in doctor or other healthcare professional office/clinic visit. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID post vaccination. The patient recovered from the events with sequelae. The events were assessed as non-serious. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
40 2021-02-04 fast heart rate 45 minutes after administration pt became nauseated, tachycardic, numbness and tingling hands and fe... Read more
45 minutes after administration pt became nauseated, tachycardic, numbness and tingling hands and feet, progressing to the knees. Injection site warm, BP 132/96. On exam, oropharynx mild erythema - no edema and no stridor. Lungs CTA. Cor - S1 S2 slightly rapid. Abd soft, non-tender, positive BS. No rashes. Gave Benadryl 50 mg and prednisone 20 mg. BP 110/72. HR 72. O2 Sat 98%. Temp 98.3F.
40 2021-02-04 palpitations Fast heart rate, sought treatment at the ER, dc paperwordkstated orthostatic hypotension
40 2021-02-04 pallor, palpitations, lightheadedness felt like she was running a fever; didn't feel well; when she stood up to use the bathroom...she was... Read more
felt like she was running a fever; didn't feel well; when she stood up to use the bathroom...she was standing and felt dizzy, like she was going to black out; she was standing and felt dizzy, like she was going to black out; heart was racing; pale; sweating/drenched her clothes in sweat; felt so weak she could not get back to my bed; breathing was rapid; stomach pain; diarrhea; patient received the first dose of bnt162b2 on 21Dec2020. She received the second dose on 14Jan2020; This is a spontaneous report from a contactable nurse. A 40-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL0142), via an unspecified route of administration in the left arm, on 14Jan2021 15:15 at SINGLE DOSE for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. The patient received the first dose of bnt162b2 on 21Dec2020. She received the second dose on 14Jan2020. Then, it was about 12 hours later (15Jan2021 at 04:00), when she stood up to use the bathroom. She felt like she was running a fever and didn't feel well: she was standing and felt dizzy, like she was going to black out, her heart was racing, and she had to lie down. She was pale and sweating; and felt so weak she could not get back to bed. Patient's husband had to help her. These feelings lasted for about 25 minutes. Patient drenched her clothes in sweat and her breathing was rapid. Then she got stomach pain and diarrhea. The outcome of events was recovered on Jan2021. The patient did not receive any treatment for the events. No follow-up attempts are possible. No further information is expected. Information on the lot/batch number has been obtained.
40 2021-02-07 heart rate increased, blood glucose increased Pfizer-BioNTech COVID-19 Vaccine Patient got first dose of vaccine on 2/3/2021. After getting dose,... Read more
Pfizer-BioNTech COVID-19 Vaccine Patient got first dose of vaccine on 2/3/2021. After getting dose, she felt anxious, increased heart rate and had a metallic taste in back of her throat. Patient was sent to ER for evaluation at 10:27am. Patient felt better and discharged at 12:11pm
40 2021-02-08 heart rate increased, pallor hard time catching her breath; throat felt a little tight; her throat felt a little tight, and she f... Read more
hard time catching her breath; throat felt a little tight; her throat felt a little tight, and she found it hard to swallow; little nervous; very lightheaded; her husband told her she looked very pale; her heart rate jumped to over 150, according to her (company name) watch; she had pins and needles up and down her entire left arm; her left arm initially felt almost totally numb from her shoulder to her finger tips, and then she felt pins and needles down the entire length of her arm.; maybe a nerve was hit when the COVID-19 Vaccine was administered in her left arm; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received the first dose of bnt162b2 (Lot Number: EK4176), via an unspecified route of administration in left arm on 25Jan2021 12:50 at single dose for covid-19 immunization. Medical history included coeliac disease from Mar2013 and ongoing. There were no concomitant medications. She said initially she was OK after she received the COVID-19 Vaccine. She said after about 5 minutes in from receiving the COVID-19 Vaccine, she had a hard time catching her breath, and her throat felt a little tight, and she found it hard to swallow. She said she thought she was nuts at first, and was a little nervous for a minute. She said the staff at the vaccination center made people wait 15 minutes after receiving the COVID-19 Vaccine before being allowed to leave. She said she actually spoke to the vaccination center staff while she was waiting for the 15 minutes to go by. She said she didn't say anything to the staff because she thought she might be crazy. She said she scheduled her second COVID-19 Vaccine dose, and after the 15 minutes went by, she left. She said her husband had drove her to and from the COVID-19 Vaccine facility location. She said 5 minutes into her car trip after leaving the facility, she became very lightheaded. She said her throat began to feel tight again (saying the throat tightness was worse than what she first experienced at the convention center), and she kept trying to clear her throat. She said her husband told her she looked very pale. She said her heart rate jumped to over 150, according to her Apple watch. She said she had pins and needles up and down her entire left arm. She clarified her left arm initially felt almost completely numb from her shoulder to her finger tips. She said she thought that maybe a nerve was hit when the COVID-19 Vaccine was administered in her left arm. She clarified the numbness improved in her left arm, but she still has a pins and needle sensation down the length of her left arm. Patient asked if it is OK for her to received the second COVID-19 Vaccine based on what she experienced after the first COVID-19 Vaccine dose. Reported if she would have been driving the car after she received her first COVID-19 Vaccine dose, she would have had to pull over on the side of the road because of the side effects she was experiencing. Reported the side effects she experienced in the car after leaving the vaccination facility, resolved after a couple minutes, with the exception of the pins and needles and numbness in her left arm. She said the pins and needles, and numbness in her left arm improved, but was still present. Reported she had a well visit not too long ago, and her blood work was perfectly fine. The outcome of the events Peripheral nerve injury, Pins and needles, Numbness of upper extremities was recovering, other events was recovered on 25Jan2021.
40 2021-02-09 lightheadedness Almost going to pass out; she sees the room as color yellow and red; sweat breakouts; This is a spon... Read more
Almost going to pass out; she sees the room as color yellow and red; sweat breakouts; This is a spontaneous report from a Pfizer-sponsored program reported from a contactable consumer (patient's mother). A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Jan2021 at single dose for COVID-19 immunisation. Patient age at vaccination was 40 years. The patient's medical history and patient's concomitant medications were not reported. The reporter stated the patient had COVID-19 vaccine 3 weeks ago and she will have the 2nd dose of vaccine 'tomorrow'. The reporter was kind of nervous about her getting the 2nd dose as the patient is experiencing a sweat breakouts and almost going to pass out, she sees the room as color yellow and red. The outcome of the events was unknown. Information on the lot/batch number has been requested.
40 2021-02-09 chest discomfort Systemic: Other- chest tightness, flushing, and signs of panic
40 2021-02-09 palpitations Systemic: Other- palpitation-Mild
40 2021-02-09 heart rate increased my feet feel so cold like ice; tingling to my hands and feet/Hand & feet tingling; leg weakness; fel... Read more
my feet feel so cold like ice; tingling to my hands and feet/Hand & feet tingling; leg weakness; felt like my heart pounding and racing/ fast heart rate; feeling too sick; started to feel flu like; muscle pain; fatigue; The initial report was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on 24Jan2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable nurse (patient herself). A 40-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), via intramuscular route of administration in the left arm on 15Jan2021 09:15 AM at a single dose to prevent COVID-19. Medical history included known allergies: latex. Concomitant medications in two weeks included ergocalciferol (VIT D) and cyanocobalamin (VIT B12). The patient did not have any other vaccine in four weeks. The patient previously received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via intramuscular route of administration in the left arm on 26Dec2020 10:30 AM. She also previously took NYQUIL and experienced known allergies. The patient was not pregnant and was not diagnosed with COVID prior to vaccination. The patient stated "I started to feel flu like around 7pm on January 15th. I had extreme muscle pain and fatigue. I woke up at 2am with what felt like my heart pounding and racing. The fast heart rate lasted about an hour. For the next +5 days, I had extreme fatigue, taking 3 hour naps at a time and still suffering from muscle pain. I attempted to go to work a couple of those days but went home half way through my shift because I was feeling too sick. Friday morning, 22Jan, I woke up feeling like I had leg weakness but I was still able to do activity normally. Saturday morning, 23Jan, I woke up with tingling to my hands and feet. I even had trouble typing at work. I made it through my shift this day with waves of muscle pain, fatigue and constant tingling to my hands and feet. Today Sunday, 24Jan I still have hand & feet tingling and my feet feel so cold like ice. I still feel 'off' overall. I plan do see my PCP this week to discuss these new symptoms in my hands and feet." The patient did not receive treatment for the events. She was not tested for COVID post vaccination. The outcome of 'heart pounding and racing/ fast heart rate' was recovered, and of remaining events was not recovered.
40 2021-02-09 palpitations uvula was dropped very low/it was so long that it touches her tongue and/or sticks to her tonsils; t... Read more
uvula was dropped very low/it was so long that it touches her tongue and/or sticks to her tonsils; top back roof of the mouth, uvula and tonsils felt tingly; migraine; light sensitivity; dry mouth; thirst; racing heart; felt very hot; felt dizzy, like how it felt when standing up too quickly, but she was already standing; sharp pain in her shoulder; This is a spontaneous report from a contactable healthcare professional (patient). A 40-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EJ1685), via an unspecified route of administration (left arm), on 31Dec2020 13:30, at single dose, for covid-19 immunization. Medical history included chronic migraines and depression. The patient has no known allergies. Concomitant medication included erenumab aooe (AIMOVIG), clarithromycin (CLARITIN), ibuprofen (IBU), mirtazapine (REMERON), paracetamol (TYLENOL), ascorbic acid (VIT C), and ergocalciferol (VIT D). The patient reported that "about 20 min" after receiving the vaccine, the patient's top back roof of the mouth, uvula and tonsils felt tingly. Then she started having a migraine, with light sensitivity, dry mouth, thirst, racing heart, and felt very hot. For a few seconds she felt dizzy, like how it felt when standing up too quickly, but she was already standing. Simultaneously, she had a sharp pain in her shoulder while she was dizzy. These reactions did not begin to subside until about 4 hours later. All these aforementioned adverse events happened on 31Dec2020 14:00 and the patient recovered from them on an unspecified date with lasting effects (recovered with sequel). After the tingly feeling in her mouth went away, she noticed that her uvula was dropped very low on an unspecified date. It did not look red and it was not sore, but it was so long that it touches her tongue and/or sticks to her tonsils. It has been 3 weeks later and her dropped uvula has not improved or changed. The patient did not recover from the event "uvula was dropped very low/it was so long that it touches her tongue and/or sticks to her tonsils". She added that she tried to get her 2nd dose on 22Jan2021, but the clinic and the physician did not feel comfortable with giving her the 2nd dose because they have not heard of any cases of side effects of the tingly mouth/uvula/tonsils and continued dropped uvula. No treatment was received for all the adverse events reported. The patient did not have COVID prior vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had the following Covid tests post-vaccination: via nasal swab on 22Jan2021 with result of negative; via nasal swab with Color on 19Jan2021 with result of negative; via nasal swab on 15Jan2021 with result of negative; via nasal swab with Color on 12Jan2021 with result of negative; via nasal swab with Color on 08Jan2021 with result of negative and; via nasal swab with Color on 06Jan2021 with result of negative.
40 2021-02-14 heart rate decreased red rash came up on her chest; upper chest muscles just below her collar bone. the pressure of the w... Read more
red rash came up on her chest; upper chest muscles just below her collar bone. the pressure of the water hitting her was painful; Diarrhea; pain and stiffness in her chest that extended across her shoulders; can't seem to regulate her body temperature; laboring to breathe; joint pain; pulse and it had dropped down to 40; She has a history of tachycardia, but her pulse kept reading normal; muscle pain; inflammation; she woke up and she was itchy around her left forearm. She was really itching; couldn't really taste, things didn't really taste right to her; immediate soreness in arm; she has pain that extends up into her neck; Nausea; hasn't had much of an appetite; sweating; left hand swelling; hives on forearm; gastrointestinal issues; Fever; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two patients. This is the first of two reports. A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL8982), intramuscular at left arm on 21Jan2021 15:38 at a single dose for COVID-19 immunization. Medical history included Tachycardia (started about 4 years ago), Hypertension (started about 4 years ago) and Essential tremor from 2020 (she has been having symptoms for a while; finally, during the summer of 2020, she was diagnosed through a neurologist) and anxiety, all ongoing; pain, back problems and sleep disorder.Concomitant medications included ongoing Tizanidine as muscle relaxant for back problems, ongoing Metoprolol tartrate for hypertension and tachycardia, Primidone for Essential tremor and ongoing Clonazepam for essential tremors, to help her sleep, and also for anxiety. No prior vaccinations (within 4 weeks). The patient got the first COVID vaccine dose. Afterwards, she went to school and it "was downhill from there". 5 days of persistent symptoms including sweating, muscle pain, joint pain and left hand swelling. It was further reported that she had to wait 15 minutes and then she drove home which is about a 35-minute drive. So about 45 mins after receiving the vaccine, she noticed her tongue, it was more on the right side of her tongue, she can't explain the sensation. She couldn't really taste. Things didn't taste right to her. This lasted 24 hours. She woke up the next day, 22Jan2021, feeling not quite right. She took some Tylenol that morning and went on into school. She took some ibuprofen in the middle of day, it wasn't a big deal. She has a history of tachycardia, but her pulse kept reading normal. She had a drink she was drinking from lunch and she ended up having the remainder of it the last few hours of that day. At about the end of her workday, around 15:30 she was finishing the Cdrink off and she said to herself "oh that taste like a regular drink again". This tongue sensation/lack of taste resolved. At that point, she got really excited because she thought this was all that she would experience with the vaccine. She was grateful she had the chance to have the vaccine. She mentions her arm was very sore right off the bat. She experienced immediate soreness in her arm right after receiving the COVID-19. She thought when they were injecting her, it hit her bone. In fact, she joked about this with the person administering the vaccine. The person at the facility told her to rub it, it actually helps with that. This kind of soreness didn't seem like a major problem. She was still experiencing this soreness. If she is sitting on the couch sideways, with her side of her arm against the couch, she has pain that extends up into her neck. It was pretty painful. Friday, 22Jan2021 (24 hours later after receiving the vaccine), by the time she got home from work, she was really sore. She had some real muscle pain around her hips and upper thighs, both of them. The soreness extended across. It was like she had inflammation that started flaring up. She felt pretty sore that evening. It wasn't like a normal muscle soreness. She went to bed because she was pretty tired. The next morning (Saturday, 23 Jan 2021), she couldn't get off the couch. She had such bad muscle and joint pain. She slept off and on, the pain was pretty bad. Her whole body had so much stiffness and inflammation. Every muscle and every joint just hurt. She confirmed that she hasn't been able to regulate her body temperature. This has been going on since Saturday evening (23Jan2021). She stated that this wasn't normal for her. She does take medications to lower heart rate but she hadn't taken it. She was talking to her best friend about how she had been sore and slept all evening. She checked her pulse and it had dropped down to 40. Her O2 level was at 92. She didn't think it was that big of a deal. Her best friend was kind of freaking out about it. She had such pain and stiffness in her chest that extended across her shoulders, it made it difficult to breathe. She was laboring to breathe. She checked her pulse thinking maybe she was feeling anxious about it and her HR was up, but it wasn't. She states happened so bad yesterday, yesterday was worse than before. She got up on Sunday morning, 24Jan2021, and took a hot shower. When the water from the shower head hit her chest, clarified as her upper chest muscles just below her collar bone, the pressure of the water hitting her was painful. However, she was able to get up, she was moving around. Still the whole time. she had this fever-ish feeling. Her kids were telling her that they were sweating because she had the house at 76 degrees. Monday morning, 25Jan2021, she woke up and she was itchy around her left forearm. She was really itching on Friday night, but she didn't think anything about it. When she took a hot shower yesterday (25Jan2021), a red rash came up on her chest and it looked like she had hives on her forearm. She didn't know if the hot water flared that up, but she doesn't have any allergies. She also had gastrointestinal issues. She has had some nausea that has lasted the entire time since she received the vaccine. She clarifies the nausea has came and gone. She hasn't had much of an appetite. They thought she had a fever yesterday at school. It was 99. something but she had already taken Tylenol a couple hours before and she was sweating so much. She states she has also had diarrhea the last few days, clarified as the last 2 days (24Jan2021). She has already spoken to someone to report her symptoms but wasn't sure about and had question about getting the second vaccine dose. She reported having gone to Urgent care where she was told she had Post covid vaccine syndrome and that she shouldn't have a problem with the second dose. She explained she went to the urgent care yesterday, 25Jan2021. She called her doctor that morning and was told to continue to treat her symptoms and take ibuprofen and Tylenol but if she got worse, to go to urgent care. So, she went to the urgent care (Product information for the Tylenol and Ibuprofen she has been taking (Ibuprofen: UPC/NDC: not provided when probed. Lot: P142385 Expiry date: Apr2023 and Tylenol: UPC/NDC: not provided when probed. Lot: P121664 Expiry date: Sep2023). The nurse just explained (Name Withheld) was having the same exact symptoms as the patient, except it was (Name Withheld) second dose. Her symptoms were identical to the patient. The patient wasn't initially sure if it was from the vaccine or if it was her anxiety. The patient didn't feel anxious and her heart rate wasn't up. The patient told she didn't think anxiety caused her to feel like she had a fever. The school nurse looked it up and found out more symptoms kind of wax and wane. Her symptoms got much worse. On 25Jan2021, Test: Rapid COVID-19 test Result: Negative. The event immediate soreness in arm was not recovered; event couldn't really taste, things didn't really taste right to her recovered on 22Jan2021 and nausea recovered in Jan2021; and unknown outcome for the other events.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021101606 same reporter/drug, similar events, different patient
40 2021-02-16 fast heart rate Immediately after receiving vaccination, patient experienced tremors, tachycardia, shortness of brea... Read more
Immediately after receiving vaccination, patient experienced tremors, tachycardia, shortness of breath. Within 30 minutes she had nausea, emesis and a strange feeling in her mouth/throat. Patient was monitored and did not require EpiPen. She was given Benadryl. She was recommended to not have a second injection due to immediate allergic reaction. She did
40 2021-02-17 fainting tired; headache; faint; vomit; This is a spontaneous report from a contactable consumer reported for... Read more
tired; headache; faint; vomit; This is a spontaneous report from a contactable consumer reported for herself. A 40-year-old female received the first dose of bnt162b2 (COVID-19 MRNA VACCINE BIONTECH, lot number unknown) via intramuscular on 04Feb2021 18:00 into left arm at a single dose for covid-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID 19. The patient medical history was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination included sertraline hydrochloride (ZOLOFT). On 05Feb2021 5:30, the patient experienced faint and vomit and on 16: 00, more vomit, tired and headache all day. No treatment received for the events. Since the vaccination, the patient has not tested for COVID 19. The outcome of the events was not recovered. Information on the lot/batch number has been requested.
40 2021-02-21 heart rate increased A fast heartbeat- Dizziness, and weakness; Numbness and tingling; The muscles of my fingers went sti... Read more
A fast heartbeat- Dizziness, and weakness; Numbness and tingling; The muscles of my fingers went stiff, where my thumbs couldn?t move away from my inner palms and my other fingers would not bend. I also had difficulty speaking, as if my tongue was numb or hard to move.  This lasted about an hour (15 hrs post-vaccine).
40 2021-02-21 fainting, loss of consciousness Patient felt light headed 5 minutes after receiving the vaccine. Patient had an episode of syncope, ... Read more
Patient felt light headed 5 minutes after receiving the vaccine. Patient had an episode of syncope, which was attended by EMS. Patient regained consciousness within 30 seconds of episode. Patient has had previous episodes of syncope, but not with vaccinations. All vitals were normal when checked by EMS. Her BG was 121 mg/dl. Patient recommended to go to the hospital to get checked out but patient refused. Waited for husband to come pick her up - 5:45pm.
40 2021-02-21 palpitations complained of feeling weird and heart racing. HR 120s BP 168/78 at 1510. by 1600 HR down to 92, BP 1... Read more
complained of feeling weird and heart racing. HR 120s BP 168/78 at 1510. by 1600 HR down to 92, BP 142/76. Patient reported feeling better. Denied shortness of breath, chest pain and denied other symptoms. Advise to see primary care physician.
40 2021-02-22 chest discomfort, palpitations Chest tightness, after taste in mouth, palpitations, temp 98.4 degrees, BP - 122/82, Pulse - 80 (pat... Read more
Chest tightness, after taste in mouth, palpitations, temp 98.4 degrees, BP - 122/82, Pulse - 80 (patient states vitals elevated from normal); shaking, dizzy, nausea
40 2021-02-23 chest pain I noticed about 2:15 (15 minutes after injection)my elbow (funny bone) was very sensitive. Then the... Read more
I noticed about 2:15 (15 minutes after injection)my elbow (funny bone) was very sensitive. Then the pain went up my arm, over my left shoulder blade, up the left side of my neck, and up into the left side of my chest. It has lasted and seemed to be more intense more than 24 hours after. 1:00pm the next day, I got extremely light headed and dizzy, sat down and it went away after a couple of minutes. Called my Primary Dr. and was told to report it. I will be seeing a Dr tomorrow the 25th. The pain, I thought was maybe a hit nerve from the injection, its kind of like an electronical zap
40 2021-02-23 pallor Patient had witnessed seizure like activity for 30 seconds. Patient transported to ER on Gurney with... Read more
Patient had witnessed seizure like activity for 30 seconds. Patient transported to ER on Gurney with RN All extremities contracted with grunting Airway maintained After activity was alert pale diaphoretic
40 2021-02-24 chest discomfort, hypertension Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium... Read more
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Hypertension-Medium
40 2021-02-25 fainting Headache, fatigue, vomiting, fainting, muscle soreness, digestive issues.
40 2021-02-26 heart rate increased, palpitations During the observation period after the vaccine, at the 5-6 minutes time frame, my heart was poundi... Read more
During the observation period after the vaccine, at the 5-6 minutes time frame, my heart was pounding like palpitations. My arm was warm up to my chest. EMS was called. They took my vitals signs. All of my vitals were normal accept my pulse was elevated 113 and then it finally came back down to 108.
40 2021-02-28 heart rate increased About an hour after vaccination, my throat was tingling and my heart rate went up. It came down afte... Read more
About an hour after vaccination, my throat was tingling and my heart rate went up. It came down after a bit and my throat/tongue felt slightly numb until I took a Benadryl.
40 2021-02-28 pallor, blood pressure increased Blood pressure jumped to 172/110. Immediate headache Almost a numb or tingly feeling spread throug... Read more
Blood pressure jumped to 172/110. Immediate headache Almost a numb or tingly feeling spread throughout my body My chest, arms and legs felt heavy. It wasn?t hard to breathe exactly, but it just felt like it was hard to actually do it. If that makes sense Then, the scary one. My brain and my mouth were saying two different things. I became really pale (per medic) and I had a hard time figuring out how to say no. My mind just wouldn?t work correctly. And when I tried to speak, it was very confusing and I was told I wasn?t making sense by the medic. Then as quickly as it started, it stopped. Periodically through out the day today, I have gotten more confused than normal about simple things. Earlier I tried to say chicken. I said potato. I was thinking chicken but my stupid mouth said something different. The medic compared my symptoms to a stroke. Which was terrifying
40 2021-02-28 heart rate increased, hypertension felt a little dizzy; felt a wave of heat from my head to my feet; my heartrate elevated; blood press... Read more
felt a little dizzy; felt a wave of heat from my head to my feet; my heartrate elevated; blood pressure as 132/90; This is a spontaneous report from a contactable other healthcare professional (patient). A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL 3247 and expiration date not provided), intramuscular in the right arm on 27Jan2021 09:30 at a single dose for COVID-19 immunization. Medical history included asthma and Seasonal Allergies. The patient is not pregnant. The patient had no known allergies. The patient did not receive any other vaccine in 4 weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included sertraline hydrochloride (ZOLOFT), fexofenadine hydrochloride (ALLEGRA), and budesonide, formoterol fumarate (SIMBICORT TURBUHALER). After receiving the vaccine on 27Jan2021 09:30, the patient walked to the waiting room, sat down and felt a little dizzy, then felt a wave of heat from her head to her feet and her heart rate elevated. This lasted for the first ~5 minutes immediately receiving the vaccine, then completely subsided. From the firefighter's report: blood pressure as 132/90 and pulse of 76. Treatment was not provided in response to the events. The outcome of the events was recovered on 27Jan2021.
40 2021-02-28 heart rate increased patient experience swollen neck, itching, and elevated heart rate. she was administered 1/2 iv dose ... Read more
patient experience swollen neck, itching, and elevated heart rate. she was administered 1/2 iv dose of benadryl by local emt. Symptoms resolved.
40 2021-02-28 fainting patient experienced swelling of the arm and fainted. patient was provided 2 cold packs from local e... Read more
patient experienced swelling of the arm and fainted. patient was provided 2 cold packs from local emt. 1 cold pack for arm. 1 cold pack for head/neck. patient was also monitored for cardiac abnormalities. no heart abnormalities were found. patient was able to return to vehicle.
40 2021-03-01 heart rate increased, chest pain Immediately after given vaccine - feeling of lump in throat. Unable to swallow, shortness of breath,... Read more
Immediately after given vaccine - feeling of lump in throat. Unable to swallow, shortness of breath, rapid heart beat, flush feeling, intense shaking (especially in legs), pain in chest, lightheadedness, dizziness (ruled anxiety) and was monitored for 40 minutes. Was given orange juice and water and allowed to remove mask to catch breath. Almost everyday since this event, the same event keeps repeating it self (almost daily for 3 weeks). I am unable to control these episodes. Emergency department (ED) has been called and I have gone to see my nurse practitioner. Been trying to make an appointment with my doctor for this week. I have lost 5 pounds (down to 105 lbs. so I can't afford to loose more weight) since this first happened and I have also lost my appetite and unable to function normally.
40 2021-03-02 loss of consciousness Person received an injection of covid-19 vaccine. She sat down for 15 minutes. Tingling began in lef... Read more
Person received an injection of covid-19 vaccine. She sat down for 15 minutes. Tingling began in left arm, and person felt slight lightheadedness during observation. As person arose from chair, tingling in left arm began to increase and she asked healthcare worker if the tingling was normal. Worker stated "I think so". Friend then aided person as she began to fall to floor - person then placed on stretcher and became unconscious. EMTs times two were summoned to stretcher and they placed heart monitor and blood pressure cuff on person. Person was transferred to the Health Center - upon transfer, person became conscious and felt a heaviness on left side of body. Able to ambulate to BR and felt heaviness of left side of body. Bloodwork and CT scan were performed at FCHC and person reported as normal. It was decided by ER Doctor to transfer person to Hosp. Blood was drawn every so often and MRI was performed which person stated was all normal. Hosp. staff kept person overnight for observation. At approximately 2000 on 2/27/2021, person states that she felt back to normal with tingling of left arm subsided. Person was released early afternoon on Sunday, February 28th, 2021 after Doctor assessed person.
40 2021-03-03 chest pain General lethargy, weakness, overall body aches and chills, fever and chest pain, tightness in back o... Read more
General lethargy, weakness, overall body aches and chills, fever and chest pain, tightness in back of throat
40 2021-03-04 pallor After getting the shot, I walked over to the observation area a few yards away. I sat down and my vi... Read more
After getting the shot, I walked over to the observation area a few yards away. I sat down and my vision went blurry and the room lights were too bright. I spoke with a dr about taking ibuprofen for my ankle, as I was told to only take Tylenol. The dr said that I was fine to take it. I didn?t want to ask about my vision because I was embarrassed and didn?t want to be stressing or panicking and that be the cause of my vision issues. But it didn?t subside so I checked with a nurse before leaving, about 15 mins after the vaccination and asked if I was ok and she said yes, that she only had 1 other person tell her about blurred vision. I walked to my car and the sun was so bright I had to shield my eyes. I got in the car and took my mask off. I looked in the mirror and my cheeks and chin were flushed but my skin was pale. My husband sat with me for 10 mins and then went in for his shot. At this point it had been a little over 30 mins since getting vaccinated. I FaceTimed my mom so I wouldn?t be alone. As we were talking she said my face was getting puffy and I was getting darker circles under my eyes. I got off of the phone with my mom and called my husband on FaceTime. I asked him to talk to the dr for me and let her see my face. She said my face was swollen and red and asked if I could breathe or felt like my throat was closing over or tongue was swollen. I told her no. Once again I was told I was ok and to take Benadryl. An hr or so after the 1st dose vaccination I was able to get Benadryl and Tylenol. In a 12hr period I took 2 doses of Benadryl and 2 doses of Tylenol. My face got better in 12-24hr but I still have blurred vision and light sensitivity.
40 2021-03-04 fainting, pallor At approximately 0924 client reported feeling light headed and nauseated. She was hyperventilating a... Read more
At approximately 0924 client reported feeling light headed and nauseated. She was hyperventilating and very anxious. She quickly became pale and fainted. At 0925 she was awoken using a cold pack to her face and chest. Her vital signs were taken and stable. She continued to feel anxious, her nausea went away. She still felt dizzy and her fingers were tingling, at approximately 0934 she felt it difficult to swallow and like something was "swollen/tight" in her throat. Lungs were clear, she was swallowing normally. At 0940 she felt her neck still "swollen", upon assessment her submandibular nodes were enlarged to palpation. Benadryl 25 mg orally x1 was given at 0945, vital signs remained stable. She began to feel better at approximately 10:00 am, she recovered and was able to ambulate. A co-worker took her home at 10:51 am.
40 2021-03-04 hypertension Pt reported feeling unusually hot and diaphoretic about 2 hours after receiving vaccine. Blood pres... Read more
Pt reported feeling unusually hot and diaphoretic about 2 hours after receiving vaccine. Blood pressure was running high with reports of 164/92, 169/102, 144/98 and then 135/89. Taken 10 minutes apart each time. Healthcare staff provided patient water and monitored during event. Began to feel normal again as bp went down. HR stayed between 69-79 during entire time.
40 2021-03-04 chest discomfort shortness of breath, chest tightness, throat fullness within 5 minutes of administration. With CPAP ... Read more
shortness of breath, chest tightness, throat fullness within 5 minutes of administration. With CPAP support (I use this at night for my autoimmune disease), I did not require intervention. Lasted 24 hours.
40 2021-03-04 fast heart rate supraventricular tachycardia lasting approximately 40 minutes with heart rate ranging from 230-250 b... Read more
supraventricular tachycardia lasting approximately 40 minutes with heart rate ranging from 230-250 b/m
40 2021-03-07 palpitations, chest pain Severe hypertension. Following the second dose I was having severe headaches. I checked my blood pre... Read more
Severe hypertension. Following the second dose I was having severe headaches. I checked my blood pressure on 2/17/21 and it was 212/116. I was having palpitations and parathesia in my right foot. I immediately contacted my provider and he confirmed my hypertension and I was prescribed two separate anti hypertensive medications. I began these medications however they have been ineffective at treating the high blood pressure. I began to have chest pains, headaches continued, and due to the hypertensive crisis I presented to the ER on 3/3/21 which required IVP BP medications, EKG, cardiac labs, etc. Prior to the COVID vaccination I have always had a normal blood pressure at all of my physical appointments.
40 2021-03-07 chest pain chest pain; loss of smell; fever; headaches; vomiting/nausea; vomiting/nausea; This is a spontaneous... Read more
chest pain; loss of smell; fever; headaches; vomiting/nausea; vomiting/nausea; This is a spontaneous report from a contactable healthcare professional (patient). A 40-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 vaccine; lot number: EL9264), via an unspecified route of administration in the left arm on 30Jan2021 15:45 at a single dose for covid-19 immunization. Medical history included heart problems, migraine, anemia, asthma and unspecified allergies. The patient is not pregnant. The patient's concomitant medications were not reported. On 30Jan2021 19:00, the patient experienced chest pain, loss of smell, fever, headaches, vomiting and nausea. The patient did not receive treatment for the events. The outcome of the events was not recovered.
40 2021-03-16 heart rate increased experienced a fast heartbeat/heart rate went up to the 160s; sweaty; dizzy; Heart threw a few PVCs; ... Read more
experienced a fast heartbeat/heart rate went up to the 160s; sweaty; dizzy; Heart threw a few PVCs; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL3249; Expiration Date: 31May2021), via an unspecified route of administration, administered in deltoid left on 22Jan2021 as 0.3 mL, single for covid-19 immunisation. Medical history included sensitive to drugs from an unknown date and unknown if ongoing. There were no concomitant medications. The patient previously took celecoxib (CELEXA) and experienced ventricular extrasystoles, dicycloverine (BENTYL) and experienced ventricular extrasystoles and heart rate went up to 180 and blood pressure dropped. She has had this [premature ventricular contractions (PVCs)] occur a few times before, a history of it. Sometimes it occurs with medicines. Stated she is sensitive to drugs. Added, this occurred with Celexa, every 5-10 beats she would throw PVCs and it occurred until she was weaned off and stopped Celexa. The PVCs also occurred with Bentyl. When she took it her heart rate went up to 180 and her blood pressure dropped. She had to be taken by ambulance and was given fluids and she believes diphenhydramine (BENADRYL) and some other things, but she is not sure. The patient got her first COVID vaccine and experienced a fast heartbeat, felt sweaty and dizzy. She was wondering if what she experienced after the first shot a normal side effect and if it would be worse with the second dose. After the first COVID vaccine shot (after the ten-minute wait), her heart threw a few PVCs, her heart rate went up to the 160s, she was sweaty, and dizzy. She had to pull the car over. Stated she is worried about getting the second dose. Wondering if this reaction could be worse. Initially stated these events all resolved that same day, but then she followed up and clarified sometimes she still feels her heart throwing PVCs again. The patient stated she turned her car towards the Emergency Room (ER), but she ended up talking herself out of going. The patient underwent lab tests and procedures which included heart rate went up to the 160s on 22Jan2021 (fast heartbeat). The outcome of the event Premature ventricular contractions was not recovered while of the rest was recovered on an unspecified date.
40 2021-03-17 palpitations, lightheadedness Increased heart palpitations; almost passed out; This is a spontaneous report from a contactable hea... Read more
Increased heart palpitations; almost passed out; This is a spontaneous report from a contactable healthcare professional (patient). A 40-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on 21Jan2021 at a single dose for COVID-19 immunization. Medical history included allergies. The patient's concomitant medications were not reported. The patient had not been diagnosed with Covid prior to vaccination. She was not pregnant. On 21Jan2021, the patient experienced increased heart palpitations and almost passed out immediately after second shot. No treatment was received for the events. Events resulted to doctor or other healthcare professional office/clinic visit. Outcome of events was not recovered. The patient was not tested for Covid post vaccination. Information on the batch/ lot number has been requested.
40 2021-03-27 fibrin d dimer increased, fainting, fast heart rate Anaphylactic reaction including throat swelling, face, hand and feet swelling. Hives Tongue Swellin... Read more
Anaphylactic reaction including throat swelling, face, hand and feet swelling. Hives Tongue Swelling Syncope Lethargy Brain Fog ongoing Livedo reticularis on upper and lower arms and buttocks first started on 1/15/2021. I still have purple mottling over these areas that do not go away when warmed. The livedo reticularis is present at all times. Dyspnea and Tachycardia first started on approximately 1/20/2021 and has become progressively worse.
40 2021-03-27 hypertension, heart rate increased lips felt numb/Numbness spread throughout face/feel numb in both arms/legs started to feel numb; lip... Read more
lips felt numb/Numbness spread throughout face/feel numb in both arms/legs started to feel numb; lips felt numb, swollen; Blood pressure was high; pulse was high; gasping for air; unable to straighten out my legs/couldn't lift her legs; ferritin levels were low; throat was closing up; unbalanced; couldn't stand up; This is a spontaneous report from a contactable consumer. A 40-year-old female patient received bnt162b2 (PFIZER), first dose at the age of 40-years-old via an unspecified route of administration, administered in arm left on 09Mar2021 13:45 (Batch/Lot Number: EN6205) as single dose for covid-19 immunisation. Medical history included hypothyroidism from an unknown date and unknown if ongoing and known allergies: sulfa from an unknown date and unknown if ongoing. Concomitant medications included rizatriptan; vitamin b complex (VITAMIN B); vitamin c [ascorbic acid]; colecalciferol (VITAMIN D); all taken for an unspecified indication, start and stop date were not reported. The patient reported within 10 minutes lips felt numb, swollen. Numbness spread throughout face, checked in with the medic and had vitals checked. Blood pressure was high, and pulse was high. Numbness spread throughout whole face. Ambulance was called and she was transported to the hospital. Within the hour of getting the shot she became unbalanced. She was gasping for air at times and started to feel numb in both arms. Upon arrival to the emergency room her legs started to feel numb. By nightfall she was unable to straighten out my legs. She couldn't stand up or lift her legs no matter how hard she tried. She was admitted to the hospital. A brain MRI was done and came back normal. Another one may be done. Bloodwork revealed ferritin levels were low and she was getting treatment for that (ferrous sulfate). While sleeping at night she woke up a few times gasping for air feeling like her throat was closing up. Today, she was able to stand up, but unable to stand up straight. She met with physical therapy and is using a walker. The patient was hospitalized for 3 days from 09Mar2021 to 12Mar2021. The patient underwent lab tests and procedures which included blood pressure measurement: high on 09Mar2021, heart rate: high on 09Mar2021, magnetic resonance imaging brain: normal on 09Mar2021, sars-cov-2 test: unknown results on 09Mar2021, serum ferritin: ferritin levels were low on 09Mar2021. Therapeutic measures were taken as a result of the events. The patient did not recover from the events.
40 2021-03-30 chest pain Sudden onset of severe pain in the right scapula about 2 days after the vaccine. Pain progressed to ... Read more
Sudden onset of severe pain in the right scapula about 2 days after the vaccine. Pain progressed to the shoulder, chest, biceps, triceps, forearm, and parts of hand. Sensations of burning, cold, and tingling are also present since.
40 2021-03-30 chest discomfort, blood pressure decreased Tightness in the chest, warmth in the chest, blurred vision and sudden drop in blood pressure to the... Read more
Tightness in the chest, warmth in the chest, blurred vision and sudden drop in blood pressure to the point of almost losing the consciousness, sweat, weak pulse. The symptoms appeared at about 4 mins after the injection in the resting area. The patient was taken on the wheelchair to lay down. The pressure was taken, the EkG. The ambulance cam after 20-30 mins. The patient started recovering but still felt tightness in the chest. The patient was taken to the Medical Center. The patient was given a blood test and urine test. The patient started feeling better and was sent home after about 3-4 hours.
40 2021-04-06 chest pain dose 1: fever chills headache for about 3 days , tylenol taken dose 2: no fever, no tylenol taken, ... Read more
dose 1: fever chills headache for about 3 days , tylenol taken dose 2: no fever, no tylenol taken, chills the first night, pain and swelling in neck and spine only at night for 2 nights , very slight headache, slight fatigue and nausea and weakness after naps, then fine by day 3 then suddenly this morning I had slight chest pain (pressure) and severe vertigo and fell in the bathroom, bp normal, temperature normal, spo2 nornal, normal hr, i had no choice but to report to work or i would lose my job (teaching in private school)
40 2021-04-08 pulmonary embolism pulmonary embolism, symptomatic
40 2021-04-17 fainting Children said I would sit up say weird things then faint; dizzy; heavy eyes; heavy head; laid down d... Read more
Children said I would sit up say weird things then faint; dizzy; heavy eyes; heavy head; laid down do not remember anything from the evening; Children said I would sit up say weird things then faint; severe vertigo; confusion; shook uncontrollably for 30 minutes; This is a spontaneous report from a contactable consumer(patient). A 40-year-old non-pregnant female patient received first dose of BNT162B2 (FIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at 10 am (Batch/Lot Number: EN 6199) as single dose (at 40-year-old) in arm left for COVID-19 immunization. The patient wasn't pregnant at the time of vaccination. The patient had ongoing allergy to intravenous pethidine hydrochloride (DEMEROL). No other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination included amfetamine aspartate/ amfetamine sulfate/ dexamfetamine saccharate/ dexamfetamine sulfate (ADDERALL). Prior to vaccination, it's unknown if the patient was diagnosed with COVID 19. Since the vaccination, the patient hasn't been tested for COVID19. At 7pm the patient became incredibly dizzy, heavy eyes, heavy head, laid down did not remember anything from the evening. Children said she would sit up said weird things then faint. Laughed and shook uncontrollably for 30 minutes. Next morning severe vertigo, confusion. Went away the third day. No seriousness criteria reported. The events resulted in doctor or other healthcare professional office/clinic visit. Treatment received for the events. The outcomes of the events were resolving.
40 2021-04-20 low blood oxigenation, fast heart rate, palpitations At 1400, nausea and yea he started. By 1800, started to become tachycardic. Took Bystolic as order... Read more
At 1400, nausea and yea he started. By 1800, started to become tachycardic. Took Bystolic as ordered. The morning of 2/2/2021 awoke at 0600 with shortness of breath, tachycardia, hypoxia, headache, body ache, chills, nausea, and dizziness. VO2 max took a noticeable drop per garmin vivoactive 3. PCP was notified and instructed to monitor. Cardiologist and neurology were consulted and prednisone taper given on 03/05/2021. Shortness of breath and tachycardia slowly changed to only on exertion improved until finally ending 3/21/2021. Continued to have palpitations, headache, and body aches until about 04/07/2021.
40 2021-04-21 fast heart rate throat constriction, dryness, scratcy/itchy. facial itiching, head, arm, back itching, eye swelling,... Read more
throat constriction, dryness, scratcy/itchy. facial itiching, head, arm, back itching, eye swelling, overheating, tachycardic. epinephrine administered, 911 called, ambulance taken across the street to ER for observation. steroids given. further benadryl taken at home. symptoms started 10-15 minutes post injection. I am allergic to PEG, my allergist put me on a pre dose of anthystamines & steroids to lessen or prevent reaction so overall reaction was fairly mild but epi was the only thing left to give as I had already had 400mg hydroxyzine, 40 mg pepcid x3, 28mg medrol x5 during the 24 hours prior to my vaccination.
40 2021-04-24 loss of consciousness lost my consciousness; My upper front teeth was broken; fell down to the front on floor; injuries wi... Read more
lost my consciousness; My upper front teeth was broken; fell down to the front on floor; injuries with my lip and teeth; injuries with my lip and teeth; chills; headache; nausea; injection site pain; muscle pain; unwell; This is a spontaneous report from a contactable consumer. A non-pregnant 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered on left arm on 06Apr2021 17:30 (Batch/Lot Number: EW0151) as single dose (at the age of 40 years old) for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications included paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported. The patient previously took BNT162B2, dose 1, (lot number=EN6204), on 13Mar2021 04:00 PM, administered on left arm for COVID-19 immunisation. The patient stated, "I got various symptoms such as chills, headache, nausea, injection site pain, muscle pain, unwell, and one day after getting the shot (on 06Apr2021 20:00) and on 07Apr2021, I lost my consciousness and fell down to the front on floor and it caused injuries with my lip and teeth. My upper front teeth was broken". The patient received no treatment. The patient was rushed to the emergency room and physician was visited. The outcome of the events was not recovered.
41 2020-12-31 fast heart rate Tachycardia approximately 10mins after receiving vaccine, lasting several minutes, trembling followe... Read more
Tachycardia approximately 10mins after receiving vaccine, lasting several minutes, trembling followed, observed by hospital staff for approximately 45mins then taken to ER, discharged with 90mins. Body aches and chills for 1-2days. dizziness, nausea, lightheaded for 4-5 days to follow.
41 2021-01-01 palpitations, fast heart rate Heart palpitations and tachycardia. BPM 102. Lasted for at least 30 minutes. Drank 8 ounces of water... Read more
Heart palpitations and tachycardia. BPM 102. Lasted for at least 30 minutes. Drank 8 ounces of water, practiced deep breathing and went back to bed lying on left side. Eventually was able to fall asleep so unsure of total duration.
41 2021-01-01 palpitations, fast heart rate, chest discomfort Random heart palpitations, tachycardia, mild chest tightness and occasional fatigue. Started five da... Read more
Random heart palpitations, tachycardia, mild chest tightness and occasional fatigue. Started five days post COVID Pfizer vaccine. Symptoms strikes at random times. No prior health issues.
41 2021-01-02 chest pain Headache, back pain 8 days after vaccine Shortness of breath, burning in chest, extreme fatigue, ba... Read more
Headache, back pain 8 days after vaccine Shortness of breath, burning in chest, extreme fatigue, back pain, intermittent headache on days 9-13 after vaccine Temperature 100.0 on day 11 after vaccine COVID tests on days 9, 10, and 13 all negative
41 2021-01-04 palpitations, hypertension, fast heart rate 15 minutes after vaccine, had flushing, hypertension and tachycardia. 50 mg benadryl liquid. Patien... Read more
15 minutes after vaccine, had flushing, hypertension and tachycardia. 50 mg benadryl liquid. Patient anxious with these symptoms, feet shaking, felt heart "beating out of chest." Vitals gradually improved after benadryl over one hour. Sent home in care of husband. Will call tomorrow to check on patient and work with allergist on follow up vaccine before receiving.
41 2021-01-04 hypertension, chest discomfort 20 Minuets after injection hot air, red , moved across face, neck. 1 hour after injection. high BP ... Read more
20 Minuets after injection hot air, red , moved across face, neck. 1 hour after injection. high BP chest heavy face and nose itchy @ 3:15 pm Benadryl 25 mg IM + difficulty swallowing.
41 2021-01-04 chest discomfort On the morning at 6:00 am of the de after the vaccination, patient woke up with pain in her body and... Read more
On the morning at 6:00 am of the de after the vaccination, patient woke up with pain in her body and headaches, with nausea and vomiting and a tight chest sensation. The doctor gave the order of solumedrol 80mg IV, TORADOL 30MG IV, TORADOL 30MG Im, Zofran 4 IV and .9 NSS 500mL IV. Afterwards the patient was discharged from the emergency room.
41 2021-01-06 heart rate increased, blood pressure increased Dizziness light headed, itchiness on head, ears felt hot and red, elevated BP and elevated HR Narra... Read more
Dizziness light headed, itchiness on head, ears felt hot and red, elevated BP and elevated HR Narrative: Tool Prednisone, Hydroxazine, and Zyrtec- all previously prescribed medications for general allergies.
41 2021-01-06 fainting Light headedness, skin flushing, syncope
41 2021-01-06 palpitations tingling in right hand progressing up arm, patient felt like heart was racing, felt hot and sweaty. ... Read more
tingling in right hand progressing up arm, patient felt like heart was racing, felt hot and sweaty. Heart rate was normal and skin felt normal to touch per medical staff. Patient denied shortness of breath, itching, no rash noted. Medical Authority, assessed patient, ordered Benadryl 25mg po. Patient intially denied need to take Benadryl, advised patient will need to be observed in emergency department. Patient did not want to go to the ED and instead took Benadryl 25mg po. Patient was monitored for 1 hour and 10 minutes, 55 minutes after Benadryl given. Patient felt ready to leave at this time.
41 2021-01-07 fainting About 5minutes after vaccination had syncope episode, in and out for about 5-10, malaise, feeling li... Read more
About 5minutes after vaccination had syncope episode, in and out for about 5-10, malaise, feeling like ? under anesthesia since then.
41 2021-01-07 atrial fibrillation, fast heart rate Got vaccine at 1:15. At 1:27. Became very hot, red rash all over, tachycardia . I alerted the nur... Read more
Got vaccine at 1:15. At 1:27. Became very hot, red rash all over, tachycardia . I alerted the nurse and at that time my watch was beeping afib.
41 2021-01-07 hypertension, blood glucose increased, blood pressure increased NauseaVomiting,HYPERtension & HYPERglycemia Narrative: Employee received vaccine. Seven minutes late... Read more
NauseaVomiting,HYPERtension & HYPERglycemia Narrative: Employee received vaccine. Seven minutes later, she began experiencing nausea and vomiting. She vomited, and a STAT team was called and we transported her to ER for evaluation. In ER, she had BP of 157/106, and blood glucose of 288. Other vitals were O2 saturation of 100%. She is diabetic and states her fingerstick glucose right before lunch at 12N was 120. After about 30 minutes observation in ER she was released, nausea subsided and she did not require antiemetic medication.
41 2021-01-07 blood pressure increased Patient received COVID-19 vaccine. After receiving vaccine patient c/o nausea and feeling "something... Read more
Patient received COVID-19 vaccine. After receiving vaccine patient c/o nausea and feeling "something in throat". Vital signs obtained at 1853 175/96, HR 68, temp 98.3 and o2 sat 99%. Repeat VS at 1903 167/103, HR 78, O2 sat 100%. Having pulse ox desaturations while speaking. Patient transported to ED in stable condition. Patient monitored in ED with resolution of symptoms and was discharged.
41 2021-01-07 blood pressure increased, heart rate increased Patient reported feeling "woozy", got the chills and HR became elevated. She appeared shaky. HR and ... Read more
Patient reported feeling "woozy", got the chills and HR became elevated. She appeared shaky. HR and BP elevated. She was given water and juice. Provider walked in and spoke with her regarding an adrenaline release causing some of her symptoms. Over the 5 minutes, patient became less shaky, BP and HR dropping. She stated she felt much better. She discharged with instructions to follow up with her PCP if needed. Provider felt she could discharge home. Several days later, patient reported continued "woozy" feeling, chills, and elevated HR. She was seen in the ED at that time, with no remarkable findings.
41 2021-01-07 palpitations, fast heart rate, chest discomfort Random heart palpitations; tachycardia; mild chest tightness; occasional fatigue; This is a spontane... Read more
Random heart palpitations; tachycardia; mild chest tightness; occasional fatigue; This is a spontaneous report from a contactable other HCP (patient). A 41-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EK5730), via an unspecified route of administration on 23Dec2020 07:00 at single dose in the left arm for COVID-19 immunization. Medical history included seasonal allergies from an unknown date. The patient previously took oxycontin and experienced allergies. Concomitant medications included women multivitamins. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient experienced random heart palpitations, tachycardia, mild chest tightness and occasional fatigue five days after receiving the vaccine on 28Dec2020 12:00. No known underlying health issues before the vaccine. The patient did not receive any treatment for the events. The outcome of the events was not recovered. The events resulted in Emergency room/department or urgent care.
41 2021-01-07 chest discomfort chest tightness arm pain nausea diarrhea body aches fatigue lost work two days
41 2021-01-07 fast heart rate chills & shivering; high fevers (peaked 102.7); tachycardia (noted to be 148 standing, 120's at rest... Read more
chills & shivering; high fevers (peaked 102.7); tachycardia (noted to be 148 standing, 120's at rest in supine); headaches; nasal/sinus congestion; fatigue; dehydration; dizziness; sore throat; GI issues; Sore arm; This is a spontaneous report from a contactable other hcp (patient). A 41-year-old female patient received first dose of BNT162B2 (COVID-19 vaccine, lot number EK5730), via an unspecified route of administration on 28Dec2020 11:00 at single dose on left arm for COVID-19 immunization. Medical history included COVID-19, hyperthyroidism, Grave's Disease, benign PVCs (Premature ventricular contractions), PACs (Premature atrial contraction) from an unknown date and unknown if ongoing, allergies, Penicillin allergy, allergy to pineapple, kiwi and pomegranate, and NUMEROUS environmental allergies (dust, weed, pollen, trees, animals. it's a long list) from an unknown date and ongoing. Concomitant medication included cetirizine, fluticasone, propylthiouracil. The patient previously took clindamycin and methimazole and experienced drug allergy. On 28Dec2020 the patient experienced sore arm (like flu vaccine) the day of the vaccination. Early the following morning (on 29Dec2020 04:00) developed chills & shivering. Progressed to high fevers (peaked 102.7), tachycardia (noted to be 148 standing, 120's at rest in supine), headaches, nasal/sinus congestion, fatigue, associated dehydration & dizziness. Subsequent sore throat & GI issues. Symptoms lasted 4-5 days. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient was not pregnant at the time of vaccination. The patient underwent lab tests and procedures which included covid test type post vaccination (nasal swab): negative on 02Jan2021, body temperature: high fevers (peaked 102.7) on 29Dec2020, tachycardia: noted to be 148 standing, 120's at rest in supine on 29Dec2020. No treatment received for the adverse events. The outcome of the events was resolved on an unspecified date.
41 2021-01-08 chest pain 2nd Pfizer vaccine was given on Thursday Jan. 7th around 1240pm. That evening I experienced expecte... Read more
2nd Pfizer vaccine was given on Thursday Jan. 7th around 1240pm. That evening I experienced expected muscle aches, chills, headache, fatigue. The next evening, Jan 8th I experienced chest pain which felt like heartburn or gastritis (which I do not typically have) in addition to the muscle aches, chills and headache returning. The morning of Jan 9th I woke up with a swollen face in addition to ongoing body aches, fatigue and headache and took 50mg of Benadryl and went to urgent care for evaluation.
41 2021-01-08 fast heart rate, heart rate increased About 5-10 minutes after receiving the vaccine experienced spontaneously elevated heart rate and lig... Read more
About 5-10 minutes after receiving the vaccine experienced spontaneously elevated heart rate and lightheartedness while sitting in a chair in the observation room. After a few minutes pulse returned to normal and lightheartedness abated. At no point did I experience shortness of breath, no facial or airway edema. Just a brief period of tachycardia and feeling of impending doom.
41 2021-01-08 heart rate increased, lightheadedness Fever, chills, weakness, myalgias, near syncope, increased heart rate.
41 2021-01-08 hypertension NauseaVomiting, HYPERtension & HYPERglycemia
41 2021-01-08 palpitations, chest pain Palpitations Narrative: Employee received vaccine at 8am on 12-29. 45 minutes later experienced flu... Read more
Palpitations Narrative: Employee received vaccine at 8am on 12-29. 45 minutes later experienced flushed feeling, heart palpitations, chest pain. See in urgent care at work, EKG showed ectopy. She was sent to the nearby emergency room, where she was monitored and given iv fluids, oxygen and tylenol. She is feeling better today one day later, and will have follow-up with cardiology. Vaccine administration may have set off underlying predisposition for PVC's, ectopy. Was aware of PVC's previously but well-controlled on diltiazem. Has now been switched to metoprolol.
41 2021-01-08 heart rate increased Recipient came in c/o feeling "flushed". Denies asthma, allergies. lightheadedness. Color pink, no h... Read more
Recipient came in c/o feeling "flushed". Denies asthma, allergies. lightheadedness. Color pink, no hives ,uticaria, SOB. @0916 VS=88-116/60-22 lungs ausc. clear. @ 0920 stated she felt increase in HR. HR = 102 RR=24 116/70 . HR 104. No c/o nausea. color continues to remain pink, lungs clear. continued observation. at 0940 HR decreased to 71, which she states is normal for her. RR-16 115/80. States she feels "better". Given instructions to call 9-1-1 if s/s of anaphylaxis or if symptoms return to notify PCP.
41 2021-01-09 chest discomfort 1/9 0230 bodyaches, chills, fatigue, fever, tightness in chest 1/10 2139-feels clammy and bodyaches
41 2021-01-09 blood pressure increased, heart rate increased I had an adverse reaction 10 minutes after my injection. My heart rate went up as well as my BP, I ... Read more
I had an adverse reaction 10 minutes after my injection. My heart rate went up as well as my BP, I felt hot and faint. Ems was on site and monitored until ambulance arrived. I was given Benadryl immediately.
41 2021-01-09 chest discomfort Wheezy, chest tightness, SOB within 45 minutes of vaccination. Took antihistamines daily x3 days aft... Read more
Wheezy, chest tightness, SOB within 45 minutes of vaccination. Took antihistamines daily x3 days after vaccine
41 2021-01-10 fast heart rate Left arm pain at 11pm on 1/8/21, fever 102.0 body aches head ache began at 5am 1/9/21 , fever and bo... Read more
Left arm pain at 11pm on 1/8/21, fever 102.0 body aches head ache began at 5am 1/9/21 , fever and body aches , tachycardia continued throughout 1/9/21, 1/10/21 tired weakness but no fever 1/11/21 all resolved except for slight left arm pain
41 2021-01-10 hypertension On 1/6/20 one hour after vaccine, had a headache and mild shortness of breath and fatigue. On 1/7/2... Read more
On 1/6/20 one hour after vaccine, had a headache and mild shortness of breath and fatigue. On 1/7/20, the shortness of breath worsened, developed muscle aches, headache and fatigue continues, blood pressure became elevated. Was seen in the Emergency Room. On 1/11/20 was evaluated by Primary Care Provider. Blood pressure medications were increased and taken off work until stable.
41 2021-01-10 palpitations c/o palpitations, dizziness
41 2021-01-11 chest discomfort 2 weeks of cough superimposed a chronic cough with mild wheeze & chest tightness. Seemed a little wo... Read more
2 weeks of cough superimposed a chronic cough with mild wheeze & chest tightness. Seemed a little worse after shot. Patient noted walk in cold air on way to vaccine apt seemed to trigger it.
41 2021-01-11 blood glucose increased Blood sugar > 300 consistently started observing day after second dose
41 2021-01-11 chest pain Chest pain and SOB with onset about 40 min after vaccine and slowly getting worse (never severe, but... Read more
Chest pain and SOB with onset about 40 min after vaccine and slowly getting worse (never severe, but definitely uncomfortable) over next few hours. Finally tried 2 puffs of my son?s albuterol about 5 hrs post vaccine and felt relief within 20?30 minutes. The next day I had more expected side effects: headache, myalgias, chills and fatigue. No recurrence of the chest symptoms.
41 2021-01-11 hypertension Dose 1 -Headache for 4 days, and fatigue Given 12/21/2020 @ 0900am Dose 2-headache, shaky, fatigue... Read more
Dose 1 -Headache for 4 days, and fatigue Given 12/21/2020 @ 0900am Dose 2-headache, shaky, fatigue, light headed, blurred vision, high blood pressure and mental fogginess Given 01/11/2021 @ 1430pm
41 2021-01-11 heart rate increased Five min after shot. Tingling in whole arm - mostly above the elbow (left arm). Felt palpitations; h... Read more
Five min after shot. Tingling in whole arm - mostly above the elbow (left arm). Felt palpitations; heart was racing. Felt warm - no sweating but getting hot. At the site - the nurse called the EMT's - they Gave me 50 mg of benydryl syrup - in 20 min. checked heartrate first in 90's and then they rechecked and it was in 80's. Blood Pressure - 130/90. Half an hour later I was home - bad headache of two days. Left arm was very sore for those two days, not swollen, though. By third day those resolved.
41 2021-01-11 palpitations Made felt dizzy, disoriented :15 minutes :50 minutes face, chest and neck became blochey with rednes... Read more
Made felt dizzy, disoriented :15 minutes :50 minutes face, chest and neck became blochey with redness and heart beat was racing or elavated heart rate nd took benydrol after became back of hands and face became flushed red again and took more benydrol and next day face and cheeks was still blouchey and red. Hot flashes and chills .
41 2021-01-11 fast heart rate Patient is mildly tachycardic, flushed, complaining of shortness of breath and sensation that her th... Read more
Patient is mildly tachycardic, flushed, complaining of shortness of breath and sensation that her throat is closing. Patient has some inspiratory stridor. She was moved to a room and given intramuscular epinephrine, diphenhydramine, famotidine, and methylprednisolone.
41 2021-01-11 fast heart rate, palpitations Patient reported to observation area for monitoring post-Injection.   No prior history of adverse ... Read more
Patient reported to observation area for monitoring post-Injection.   No prior history of adverse reactions or allergic reactions to any medications, vaccines or injections.   She reported to myself (Dr.) at 4:05 pm with feeling of lightheadedness, flushing and racing heart beat.   Initial Exam: Vitals: 143/87, HR 114, O2 sat 100% CV: Tachycardia, regular. No m/r/g Respiratory: CTAB. No w/r/r Skin: Facial flushing but otherwise no rash or hives. Oral: no tongue or lip swelling   Patient placed in supine position on stretcher, received water hard candy.   Repeat vitals @ 4:30: 151/84, HR 107, Sp O2 100% Exam: Unchanged.   After an additional 15 minutes of rest patient was able to ambulate without assistance and ultimately return to home via uber. Boyfriend was alerted.
41 2021-01-12 nosebleed Numbness in the site of the injection which is the left side, my arm, only on the left side; Bloody ... Read more
Numbness in the site of the injection which is the left side, my arm, only on the left side; Bloody nose; This is a spontaneous report from a contactable healthcare professional (patient). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EJ1685; Expiration date was not reported) on 04Jan2021 on the left arm at a single dose for COVID-19 immunization. The patient had no relevant medical history. The patient's concomitant medications were not reported. On an unspecified date, the patient had numbness at the site of the injection which was the left side (arm), and only on the left side; and had bloody nose. The patient had received treatment for the reported adverse event. The outcome of the events, 'numbness at the site of the injection' and 'bloody nose', was unknown.
41 2021-01-12 chest pain The vaccination was given at 1802. At approximately 1804 the patient stated she did not feel quite ... Read more
The vaccination was given at 1802. At approximately 1804 the patient stated she did not feel quite right and something may be wrong. She stated she was feeling all warm. She was complaining of mild heat or burning traveling from the vaccination arm, across her chest to the other arm and down her torso. Did not complain of any breathing difficulties or other symptoms. Her heart rate and respirations were normal. Upper extremities were examined for redness or hives - none found. The heat flash lasted about 2 minutes then she stated she felt normal. She was observed for another 20 minutes. She was examined again before leaving and no signs or symptoms were noted at that time. She felt normal before leaving the clinic.
41 2021-01-13 chest pain 10 hours after injection of 2nd vaccine I experienced body aches, chills, nausea that lasted 2 days.... Read more
10 hours after injection of 2nd vaccine I experienced body aches, chills, nausea that lasted 2 days. 3rd day post injection nausea continued and started experiencing back/flank pain. 4 and 5th day post injection still have nausea/back pain and chest pain, headache. Overall tiredness and weakness. I was also tested for Covid and it was negative.
41 2021-01-13 blood pressure increased 1600 hrs. Stated throat burning and felt like it was closing up, hot flashes, ears ringing, and warm... Read more
1600 hrs. Stated throat burning and felt like it was closing up, hot flashes, ears ringing, and warm. Vitals monitored every 15 minutes with first set being within range with the exception of elevated BP at 150/90. Benadryl 25 mg given PO. Sitting in chair, able to answer all questions with no apparent distress in speaking. Continued symptoms above at 1630 administered an additional 25mg benadryl PO . Alert and oriented, able to call spouse for a ride home. Due to continued symptoms rapid response team was called for evaluation and took over care to be transferred to ER for further monitoring and evaluation.
41 2021-01-13 blood pressure increased Approximately 20 minutes after the shot I became dizzy and nauseous. Followed my my upper lip and no... Read more
Approximately 20 minutes after the shot I became dizzy and nauseous. Followed my my upper lip and nose tingling and then the whole face tingling and numb feeling as if I had gotten a novacaine shot. This has continued all night but is currently more on my left side of face and down left forearm tingling/numb.
41 2021-01-13 palpitations, blood pressure increased Approximately 5 minutes after receiving the vaccine, pt reported feeling light-headed and a sensatio... Read more
Approximately 5 minutes after receiving the vaccine, pt reported feeling light-headed and a sensation that her heart was racing . Slightly elevated BP returned to baseline by 1436.
41 2021-01-13 heart rate increased, blood pressure increased Extreme hot flash that felt like needles all over the body, knees felt like they were on fire, lips... Read more
Extreme hot flash that felt like needles all over the body, knees felt like they were on fire, lips and tounge were tingling, bad taste in mouth, elevated blood pressure and heart rate, and dizzy. Dissipated after about 30 minutes, and left a headache.
41 2021-01-13 lightheadedness I was approached by a person in the center at approx 1000 stating she had an employee that received... Read more
I was approached by a person in the center at approx 1000 stating she had an employee that received their first COVID vaccine and was not feeling well. I went over to find the employee sitting in the person's office in a chair. She was able to tell me she received her first COVID vaccine approx 30 mins ago. She stated she stayed there for the 15 mins after the vaccine with no reaction. She is now having ringing in her ears, feeling lightheaded, hot, nauseaus, and "I feel like I am in a cloud." She denies allergies or past hx of vaccine reactions. Denies hx of anaphylaxis. She denied any sob or chest pain. Employee was holding her head. She stated she had only had some coffee and juice today and was feeling hot. BP was taken and was 112/90 and she is not tachy and no resp distress observed. Patient was able to speak to me in full complete sentences initially. Another person came over and the employee was asked if she could stand and walk. Employee stated she felt she could stand and walk and when she did this she had to hold onto something to avoid falling and she was sat back down. Emergency services was called and employees speech was slow and almost slurred at times. Emergency services arrived and transported employee.
41 2021-01-13 chest discomfort Shortness of breath; Anxious; Chest Heaviness; This is a Spontaneous report from a contactable pharm... Read more
Shortness of breath; Anxious; Chest Heaviness; This is a Spontaneous report from a contactable pharmacist. A 41-year-old non-pregnant female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: El1284) via intramuscular route of administration on left arm at a single dose for COVID-19 immunization at a nursing home. The patient had no relevant medical history and no known allergies. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks, or any other medications within 2 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced shortness of breath, anxious, and chest heaviness on 07Jan2021 11:00. The events were reported as non-serious but resulted in visit to the Emergency room/department or urgent care. Treatment and outcome of the events were unknown. The patient had not been tested for COVID-19 since the vaccination.
41 2021-01-13 fast heart rate, chest discomfort, hypertension severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of brea... Read more
severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath.; severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath.; severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath.; severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath.; severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath.; severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath; severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath; This is a spontaneous report from a contactable nurse (reporting for herself). A 41-year-old non-pregnant female patient received two doses of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), both via an unspecified route of administration in the left arm, the first dose on 16Dec2020 09:00 (lot number: EH9899) and the second dose on 08Jan2021 07:15 (lot number: EL0140), both at a single dose for COVID-19 immunization. Medical history included ongoing anxiety, from an unspecified date. The patient had no known allergies. Concomitant medication included escitalopram oxalate (LEXAPRO), acetaminophen (MANUFACTURER UNKNOWN), naproxen sodium (MANUFACTURER UNKNOWN), ibuprofen (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19. On 09Jan2021 at 01:30 AM, the patient experienced severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath, all of which were reported as being life-threatening. The patient went to the Emergency room due to the events. Therapeutic measures were taken as a result of the events and included: methylprednisolone sodium succinate (SOLUMEDROL) 125 mg, famotidine (MANUFACTURER UNKNOWN) 20 mg and diphenhydramine hydrochloride (BENADRYL) 50 mg. The clinical outcome of severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath was recovering.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
41 2021-01-13 fast heart rate, hypertension within 10 minutes of vaccination, patient c/o feeling warm and nausea. symptoms progressed over for... Read more
within 10 minutes of vaccination, patient c/o feeling warm and nausea. symptoms progressed over forty minutes to include hypertension, nape of neck "fullness", weakness, and tingling hands. HR in '70's initially then progressed to tachycardia in 130's. EMS called for ED transport.
41 2021-01-14 chest discomfort Dizzy at work around 4pm. Tightness in chest worked its way down to stomach - felling queasy and sic... Read more
Dizzy at work around 4pm. Tightness in chest worked its way down to stomach - felling queasy and sick to the stomach. When driving home from work, she instantly felt really hot and had a lot of flushing that felt like a hot flash. Hot all over. Had to pull over and take off layers of clothes. Sat with the air on in the car. Burning sensation when she got home felt like brillo pad was used on face. Burning sensation on cheek all the way down to chin. Face was really on fire. Today, the burning sensation have gotten better, but her cheeks still have prickly, tight sensation. Headache at 8pm yesterday when she was trying to go to bed at the back of the head. Felt like a lot of pressure.
41 2021-01-14 heart rate increased Extreme chills with body shaking for 6 hours, fever, sore throat, nausea, excruciating headache, ext... Read more
Extreme chills with body shaking for 6 hours, fever, sore throat, nausea, excruciating headache, extremely high resting heart rate (over 100-usually under 60)
41 2021-01-14 blood pressure increased, hypertension Headache, Myalgia, Fever, HYPERtension, employee stated after receiving vaccine had body aches, join... Read more
Headache, Myalgia, Fever, HYPERtension, employee stated after receiving vaccine had body aches, joint aches, photophobia, headaches, fever, hypertension Narrative: Employee stated H/A, body aches, joint aches, photopobia, fever, hypertension BP 170/100, employee sent to to ER due to elevated b/p. denies any other symptoms.
41 2021-01-14 palpitations I started developing walloping palpitations around 3 hours after vaccine was given. They have conti... Read more
I started developing walloping palpitations around 3 hours after vaccine was given. They have continued now for 18 hours post vaccination and I have never had these before in my life. I have numerous per hour but can be symptom free from time to time. No significant cardiac history before.
41 2021-01-14 heart rate increased Slight tingling sensation on tongue and part of throat Heart rate increased with anxiety
41 2021-01-14 palpitations became anxious. c/o SOB, palpitations, dizziness, felt she was going to faint. Was evaluated in ED... Read more
became anxious. c/o SOB, palpitations, dizziness, felt she was going to faint. Was evaluated in ED, discharged home
41 2021-01-14 heart rate increased hot flash and rapid heartrate
41 2021-01-14 heart rate increased lethargy, body aches, dizziness, numbness in arms, dizziness, nausea, high pulse rate
41 2021-01-15 palpitations, blood pressure increased Immediately experienced racing heart and severe dry mouth. My KARDIA 6-lead EKG stated "Possible AFi... Read more
Immediately experienced racing heart and severe dry mouth. My KARDIA 6-lead EKG stated "Possible AFib" and heart rate was 145-155. Blood pressure became elevated much higher than baseline (Normal is 90/60). Paramedics came to evaluate and performed numerous 12-lead EKG's and noted multiple Premature Ventricular Contractions and transported me to the hospital where I was observed and consulted on from ED Physician. Later was evaluated by electrophysiology cardiologist with echocardiogram and EKG. Multiple physicians have advised not to get second vaccine.
41 2021-01-16 palpitations AM after vaccine patient reported achiness, chills and palpitations starting 3-4 hours after vaccine... Read more
AM after vaccine patient reported achiness, chills and palpitations starting 3-4 hours after vaccine injection
41 2021-01-16 chest discomfort Vax injection at 4:05 pm, Symptoms started at 4:10 pm. burning throat, difficulty swallowing, tight... Read more
Vax injection at 4:05 pm, Symptoms started at 4:10 pm. burning throat, difficulty swallowing, tightness in chest. 25 mg benadryl given with a little improvement. Symptoms return and worsen- 25 mg benadryl given and rapid response called. Taken to ED and admitted. Given 125 mg of solu-medrol IV and albuterol inhaler. Symptoms eased and discharged to go home. 01-15-2021- 4:30am woke with burning in throat mild difficulty swallowing. Took 50 mg benadryl and inhaler. Symptoms eased. 01-16-2021- felt better 01-17-2021- 5:00 pm- noticed onset of tightness in throat, feeling of something caught at back of throat and start of mucus drainage. Continued clearing of throat. Took 25 mg of benadryl and inhaler.
41 2021-01-16 chest discomfort Within 25 minutes of receiving the vaccine, my left arm became very heavy and there was a tingling/n... Read more
Within 25 minutes of receiving the vaccine, my left arm became very heavy and there was a tingling/neuro sensation in left wrist/hand. A pressure began in the anterior of my throat which increased gradually. I sought treatment in our Urgent Care just after noon that same day. The Provider monitored my vitals which were good and administered liquid Pepcid. Said Provider chose not to give Benadryl as I had taken Zyrec that morning for my allergies. I was discharged from the Urgent Care and went back to work at 1245. At 1730 hours, I had a slight headache above my right eye and extreme right-sided jaw pain with tooth sensitivity. These lasted for only 10 minutes. At 1830, the anterior and bilateral portions of my throat began to feel "prickly" and I developed a wheeze. I used an albuterol inhaler to relieve the wheeze successfully. At this time I also developed an itchiness throughout my whole body, worse on left side than right side. I took 100mg of Benadryl with no relief. At 0300, I took another dose of 100mg of Benadryl with no relief. I also took an itch pill/antihistamine of my husband's which provided no relief. At 0800, I took 20 mg of Zyrtec. At 1030, I took 100mg of Benadryl. I continued to use Benadryl throughout the day, every 4-5 hours. At 1800, I had a fullness in my throat, a tightness in my chest and my left shoulder blade felt almost numb. I also had a hoarse voice which passed by the next morning. The chest tightness was intermittent over the next day or two. On Friday, the itchiness had improved some but was still prominent. I continued to use Zyrtec and Benadryl throughout the day. My Primary Doctor called in Prednisone if needed. By Saturday morning, I felt MUCH better. Today is Sunday and I am no longer itching and I feel so much better today.
41 2021-01-17 heart rate increased 10 minutes after vaccine administered was lightheaded, heart rate increased. This lasted no more th... Read more
10 minutes after vaccine administered was lightheaded, heart rate increased. This lasted no more than 2 minutes and resolved on its own with no further recurrence. A few hours later developed rash to upper body (chest & back areas). Treated rash with antihistamines (Benadryl, Pepcid), Zyrtec. Rash resolved after 7 days, then flared after allergy medications stopped. Rash completely resolved at 16 days post vaccine.
41 2021-01-17 oxygen saturation decreased, chest pain, palpitations COVID positive 11/27/20. Oxygen saturation dropped to 90% with exertion and 94% resting. Also had ch... Read more
COVID positive 11/27/20. Oxygen saturation dropped to 90% with exertion and 94% resting. Also had chest pain and sinus tachycardia. Received first COVID vaccine 12/18/20.Developed continuous vomiting 1.5 hours later then muscle aches and cramps as the day went on. Symptoms were gone later the next day except site soreness. Developed SOB and wheezing on 12/24/20. Went to ER - no treatment. Called her pulmonologist and increased diltiazem for the weekend. Called cardiologist 12/28/20 and was put on Corlanor. Took care of acute issues, but still had some SOB and palpitations.
41 2021-01-17 lightheadedness I developed lightheadedness within 2 minutes of receiving covid 19 vaccine. I did not faint. I deve... Read more
I developed lightheadedness within 2 minutes of receiving covid 19 vaccine. I did not faint. I developed labored breathing around the same time as the lightheadedness. I was evaluated in the emergency room and diagnosed with a vasovagal event. The evening of the vaccine, I developed mild body aches, especially in the legs. The morning after the vaccine, I developed headache ,nausea and vomited once.
41 2021-01-17 blood pressure increased, heart rate increased Shot 1- shaky, weak, increased heart rate, mild swelling of mouth tongue and throat - resolved in a ... Read more
Shot 1- shaky, weak, increased heart rate, mild swelling of mouth tongue and throat - resolved in a day Shot 2 a shaky, weak, increased heart rate and blood pressure, moderate swelling of face, tongue, throat, intermittent dizziness and Left eye blurriest, left facial decreased sensation and pain from mouth to ear, pain behind Left eye - symptoms wax and wane throughout the day
41 2021-01-17 fast heart rate, chest discomfort tightness in my chest; sob/shortness of breathe; headache; chills; body aches; extreme fatigue; bloa... Read more
tightness in my chest; sob/shortness of breathe; headache; chills; body aches; extreme fatigue; bloating; shakes; blurred vision and couldn't focus on my cell phone; tachycardia/heart rate went up; dizziness/ felt dizzy; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine; Lot number: ER9231), via an unspecified route of administration in the right arm on 06Jan2021 at 10:00 AM at a single dose as COVID-19 vaccine. Medical history included anaemia and anaphylactic reaction to shellfish. The patient was not pregnant at the time of vaccination, did not receive any other vaccine within 4 weeks prior to the COVID vaccine, and had no other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to the vaccination and was not tested for COVID-19 post vaccination. There were no concomitant medications. On 06Jan2021, within 2 hours (at 12:00 PM), the patient experienced blurred vision, within 4 hours tachycardia and dizziness, within 8 hours headache, chills, body aches, and extreme fatigue, and within 12 hours, tightness in her chest, SOB, extreme fatigue, and body aches. As treatment, the patient received ibuprofen. The patient stated that she had a pretty severe reaction. She also informed her employer but nobody helped. They observed her 15 mins. post-vaccination. She was fine within 15 minutes. It was also reported that within 2 hours, she had blurry vision, tachycardia, and felt dizzy. In the middle of the day, she felt chills, shivers, dizziness, bloating, and headache. The patient also stated that she experienced shakes and taking a shower hurt, also, chest was tight all day. It was further reported that when she was sent back home from work, she started having a severe body ache, fatigue, chills, and shivers. She experienced tightness in her chest , shortness of breath, and she could barely get out of bed. This lasted all day. She still had the blurred vision and couldn't focus on her cell phone. She felt a little bit better today but was still not 100%. She contacted her MD who advised her to report this to Pfizer. The patient wanted to know if it was safe to receive the second dose of COVID-19 vaccine. It was reported that the events resulted in a doctor or other healthcare professional office/clinic visit. Outcome of the event 'Vision blurred' was not recovered, for the event 'Tremor' was unknown, while for the rest of the events was recovering. The case was reported as non-serious (did not result in death, was not life-threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, and did not result to any congenital anomaly/birth defect).
41 2021-01-18 chest discomfort 22 hours after the second dose started to have an allergic reaction, hives all over back and chest a... Read more
22 hours after the second dose started to have an allergic reaction, hives all over back and chest and neck. Took benedryl and pepcid at home OTC. The next morning woke up with hives, flushed feeling, and chest/throat tightening. Went to the ER was administered iv medications. Went home. 4 Hours later started again with chest and throat tightening and swelling of the eyes. Kept having break through reactions when medications were wearing off. The ER md that I saw called in some home medications that I started taking. Pepcid and Prednisone. 7 days later still having to take benedryl and pepcid due to eye itchiness and swelling.
41 2021-01-18 fast heart rate Developed nausea 1-2 hours after vaccine. Developed mild muscle aches and cramps later that day. Sym... Read more
Developed nausea 1-2 hours after vaccine. Developed mild muscle aches and cramps later that day. Symptoms gone by next day except residual site soreness. Asthma has worsened and is using Albuterol inhaler 1-2 times daily since second dose. Woke up 1/19/21 at 3am. Developed temperature then was diaphoretic. Vomited. Developed SOB, tachycardia, and wheezing.
41 2021-01-18 palpitations Roughly 2-3 minutes post injection as I was sitting in the designated waiting area, (as instructed ... Read more
Roughly 2-3 minutes post injection as I was sitting in the designated waiting area, (as instructed by the nurse to sit there for 15 minutes post injection to assure no adverse effects) I began to get very short of breath, I felt that I had to take my mask off to breath properly. ( I did not remove my mask) My heart then started to race and I felt a warming, tingling feeling throughout my body. I felt a little hot and light headed. I stayed sitting in my chair, tried to take some deep breath, and everything went away. This lasted about 30 to 60 seconds. I did NOT report this to anyone there, as I was unsure if I was actually having a reaction or not. Since it went away on it's own, I did NOT report it to anyone. I stayed for about 15-20 minutes post injection and then I left and drove home. I did feel tired and my arm is sore at injection site, but other than that, no other effects.
41 2021-01-18 chest discomfort, fast heart rate Within 2 hrs- blurred vision, dizziness, sore arm Within 4hrs- tachycardia, lightheaded, headache, f... Read more
Within 2 hrs- blurred vision, dizziness, sore arm Within 4hrs- tachycardia, lightheaded, headache, fatigue Within 6hrs- headache, extreme fatigue, SOB Within 8hrs- tightness in chest, extreme fatigue, body aches, chills plus all others listed
41 2021-01-18 chest discomfort, palpitations palpitations, chest heaviness, numbness in fingers and toes, fatigue, nausea lasting 1+ week
41 2021-01-19 chest discomfort Fever of 100.4, body aches, chest tightness and headache. Tylenol dosing for 24 hours remedied the s... Read more
Fever of 100.4, body aches, chest tightness and headache. Tylenol dosing for 24 hours remedied the side effects.
41 2021-01-19 platelet count decreased, chest pain Patient got her 2nd dose of Pfizer covid vaccine on 1/8. On 1/11 she had intermittent chest pain th... Read more
Patient got her 2nd dose of Pfizer covid vaccine on 1/8. On 1/11 she had intermittent chest pain that lasted a few days and started to notice small purpura rash on left breast. She didn't think much of it but noticed the same type of rash on her pant line and then right thigh. On 1/15 she called Occupational Health who advised her to go straight to the ED.
41 2021-01-19 pallor, blood pressure increased, heart rate increased, palpitations The patient self-reported this adverse reaction through the hospital electronic reporting system. I... Read more
The patient self-reported this adverse reaction through the hospital electronic reporting system. In the patient's own words, "After receiving the COVID vaccine, I became very dizzy and weak. I felt like I was going to pass out more than once. Arms, legs, hands, and feet tingled, then went numb. Heart started racing, and I felt warm all over. My coworker told me I was very pale. I looked up reactions on the site and decided go to the ER and get checked. On the way over, I become slightly SOB. Once there my BP and HR was elevated, but after about an hour or so returned to normal. I still felt very weak and had some hand and leg tingling".
41 2021-01-20 chest discomfort Pressure in chest(like something was sitting on my chest)lasted 4-5days post vaccine
41 2021-01-20 fainting, fast heart rate Sudden onset of tachycardia 220 beats, faint, week, sweating, clammy, hot, cold, dry heaving, feel... Read more
Sudden onset of tachycardia 220 beats, faint, week, sweating, clammy, hot, cold, dry heaving, feeling like going to pass out
41 2021-01-20 palpitations itching; palpitations; back ache; had an allergic reaction; full blown hives; rash on her face, ears... Read more
itching; palpitations; back ache; had an allergic reaction; full blown hives; rash on her face, ears, legs and arms; fever; tired; sore throat; swollen lymph nodes; chills; This is a spontaneous report from a contactable nurse (patient) via a Pfizer-sponsored program. A 41-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EJ1685, expiry: Mar2021) intramuscularly on 19Dec2020 at a single dose for covid-19 immunisation. Medical history was reported as none. The patient's concomitant medications were not reported. On 20Dec2020, the patient experienced fever, tired, sore throat, swollen lymph nodes and chills. On 08Jan2021, the patient experienced rash on her face, ears, legs and arms. On 09Jan2021, the patient had an allergic reaction and had full blown hives. It was also reported that the patient experienced itching and back ache on an unspecified date. The patient also experienced palpitation on an unspecified date and she went to the emergency room in which she was prescribed with lorazepam (ATIVAN). The patient was also treated with naproxen (ALEVE) for fever and back ache, steroid (unspecified) for allergic reaction and hives, TRIAMCINOLONE cream for the rash and HYDROXYZINE for the itching. Outcome of the events fever, tired, sore throat, swollen lymph nodes and chills recovered on 21Dec2020 while for the events full blown hives, itching, had an allergic reaction, rash on her face, ears, legs and arms, palpitations and back ache was unknown.
41 2021-01-20 heart rate increased states received the covid vaccine - developed inc hrt rate, rigors, flushing was monitored in the va... Read more
states received the covid vaccine - developed inc hrt rate, rigors, flushing was monitored in the vaccine clinic, and then escorted to the ED -states the ED observed until sx dec - was told she had a catacholemine response, states is feeling fatigued
41 2021-01-21 fainting Congestion, out of body experience (like a fog where you cannot think), headache, syncope
41 2021-01-21 fast heart rate, hypertension, heart rate increased Pfizer COVID-19 Vaccine EUA. At 1317 (18 minutes after vaccine administered) Patient observed to hav... Read more
Pfizer COVID-19 Vaccine EUA. At 1317 (18 minutes after vaccine administered) Patient observed to have rash to chest and neck. Patient stated she felt "warm in her neck and inner thighs". Rash progressed to ears and face. Patient stated she was having "tingling in the mouth w/progression to her face and eyes. Patient taken to triage area for observation, VS Q 5 mins. Patient noted to have tachycardia PR 103 and elevated BP 178/100 on initial VS. Pulse rate decrease after 5 minutes to 95. BP remained elevated. Patient placed on gurney in recumbent position and water given. Patient given a mirror to view face and patient stated " my face is swollen slightly". Absent selling to lips or tongue. EPI pen 0.3mg/0.3ml auto injector administered at 1339.patient transported to site ED for further evaluation. O2 applied enroute to ED at 4L/min via NC when patient stated she felt a little lightheaded. Patient care transferred to ED and report given.
41 2021-01-22 chest pain, chest discomfort About one hour post injections I started developing chest pain and pressure. It worsened throughout ... Read more
About one hour post injections I started developing chest pain and pressure. It worsened throughout the day and because I was worried about a cardiac event, I went to the emergency room.
41 2021-01-22 chest pain Chest pain, lethargy, burning airway
41 2021-01-22 blood pressure increased For informational purposes, to hopefully add to current research:. Dose 1: administered in the am-li... Read more
For informational purposes, to hopefully add to current research:. Dose 1: administered in the am-lightheaded, tired, sleepy began after an hr or so after administration and continued throughout the day, blood pressure increased significantly after a few hrs (151/94); was much better the following day, only feeling tired and having pain at site of vaccine/upper arm. Dose 2: administered in the pm- lightheaded slightly for the first hr, more dizzy after 2.5 hrs, blood pressure ok, but severe headache; woke up with chills 2-3x that night, woke up with headache still, no fever, joints aching more than usual in spite of taking lots of ibuprofen; slight upper arm pain. Headaches have continued and my typical joint/back pains seem to be a lot worst and not really responding to ibuprofen. May be coincidence, maybe not. Thank you.
41 2021-01-23 heart rate increased Sharp pain at bridge of nose that became a tightening across entire face and forehead, rapid heartbe... Read more
Sharp pain at bridge of nose that became a tightening across entire face and forehead, rapid heartbeat, nausea, numbness in lips, sinuses pushing on roof of mouth, difficulty swallowing for about 15 minutes about a half hour after taking vaccine. Then about 6 hours same symptoms but without rapid heartbeat, swallowing issues were worse, took Benadryl, after about an hour symptoms lessened and I fell asleep. Next morning roughly 13 hours later would randomly have tightness in face and under chin. Lasted off and on all day.
41 2021-01-24 heart rate increased body aches, headache, nausea, vomiting, fever, chills, elevated pulse, generalized weakness and dizz... Read more
body aches, headache, nausea, vomiting, fever, chills, elevated pulse, generalized weakness and dizziness. Pain to left arm
41 2021-01-25 chest discomfort Itchy throat, sudden warmth, see spots, chest tightness.
41 2021-01-25 palpitations My heart was pounding so hard that it woke me up. My Oura ring was able to record the elevation in m... Read more
My heart was pounding so hard that it woke me up. My Oura ring was able to record the elevation in my heart rate. I went from the 50's in a dead sleep to the 80's between 7-8am. Otherwise I had general lethargy, fatigue, and arm soreness. I did not have a fever.
41 2021-01-25 palpitations heart was racing; increased respiratory rate; tingling in the tongue; full/swollen feeling in the to... Read more
heart was racing; increased respiratory rate; tingling in the tongue; full/swollen feeling in the tongue; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received the first dose of BNT162B2 (Lot/batch number and expiry date unknown), intramuscular on12Jan2021 07:30 at single dose in the left arm for COVID-19 immunization. Medical history included PCN allergies from an unknown date. There were no concomitant medications. On 12Jan2021 07:45 about 15 minutes after the injection, the patient felt like heart was racing, increased respiratory rate and tingling in the tongue. Heart rate and respiratory rate quickly returned to normal but the tingling and full/swollen feeling in the tongue continued for about 1.5 hours post injection. The patient did not receive any treatment for the events. The patient did not receive any other vaccines within four weeks prior to the vaccination and did not receive other medications within 2 weeks of vaccination. The vaccine was given in the Hospital. The outcome of the event "heart was racing" and "increased respiratory rate" was recovered on Jan2021 while outcome of the other events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
41 2021-01-26 fainting I had one episode of syncope in the morning on 1/22/2021 after waking up in the morning, two days... Read more
I had one episode of syncope in the morning on 1/22/2021 after waking up in the morning, two days after the 2nd shot but within 48 hrs. Other than that, I just had a moderate left arm pain (starting on 1/21/2021). Also generalized low energy level (starting on 1/21/2021) and very mild muscle soreness especially with both legs (starting on 1/22/2021) .
41 2021-01-26 palpitations Starting from 12 hours after receiving the second dose of Covid vaccine, I?m experiencing palpitati... Read more
Starting from 12 hours after receiving the second dose of Covid vaccine, I?m experiencing palpitations, fatigue, muscle pain and dizziness. I took Tylenol and felt better
41 2021-01-26 fainting seeing gray spots room started spinning felt nauseous collapsed on the table; loss of vision; loss o... Read more
seeing gray spots room started spinning felt nauseous collapsed on the table; loss of vision; loss of hearing; seeing gray spots room started spinning felt nauseous collapsed on the table; seeing gray spots room started spinning felt nauseous collapsed on the table; seeing gray spots room started spinning felt nauseous collapsed on the table; loss of the onion ability to stand up or walk; loss of the onion ability to stand up or walk; This is a spontaneous report from a contactable other health professional (patient), a 41-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) at left arm on 14Jan2021 08:30 AM at single dose for covid-19 immunization in a public health facility. Medical history was none. Allergies to medications, food, or other products was No. Patient was not pregnant at the time of vaccination. the patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. the patient received within 2 weeks of vaccination included amphetamine salts 15 mg. Patient woke up in the middle of the night got out of bed walk down a set of stairs started seeing gray spots room started spinning felt nauseous collapsed on the table. Had to call her husband to carry her back up the stairs. she had loss of vision loss of hearing and the onion ability to stand up or walk. He laid her back in bed to pick up his phone and call emergency services within five minutes everything had gone back to normal. adverse event start date was 15Jan2021 03:00 AM. the adverse event result in doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The final outcome of the events was unknown (if patient recovered: Unknown). It was reported as non-serious. Seriousness criteria Results in death, Life threatening, caused/prolonged hospitalization, Disabling/Incapacitating and Congenital anomaly/birth defect were all no.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
41 2021-01-26 hypotension, fast heart rate weak; hot flashes; cramping; joints hurt; her hands & feet were so cold they hurt (like when holding... Read more
weak; hot flashes; cramping; joints hurt; her hands & feet were so cold they hurt (like when holding snow with bare hands); her hands & feet were so cold they hurt (like when holding snow with bare hands); anxiety; dizzy; her body feels weird; sweating; b/p low; throat hurts; tachycardia (119-135); 100.4; chills; body ache; nausea; vomiting; pounding headache; eyes burning; face & neck felt flushed; This is a spontaneous report from a non-contactable nurse (patient). A 41-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), intramuscular on 11Jan2021 16:00 at a single dose on left arm for COVID-19 immunization. Medical history included asthma, hypoglycemia, vitamin d deficiency, migraines, and allergy to Ilizone (unspecified). The patient was not diagnosed with COVID prior to vaccination. The patient was not pregnant at the time of vaccination. Concomitant medications included loratadine (ALAVERT), phentermine, ibuprofen, and paracetamol (TYLENOL). The patient was administered with first dose of bnt162b2 on 21Dec2020 for COVID-19 immunization (product-COVID 19, brand-Pfizer, lot number-EH9899, administration time-11:45 AM, administrator route-intramuscular, vaccine location-right arm). The patient previously took salbutamol sulfate (VOLMAX) and experienced allergy. No other vaccines in four weeks prior to COVID vaccination. On 11Jan2021 17:00, the patient experienced body temperature of 100.4 (no unit reported), chills, body ache, nausea, vomiting, pounding headache, eyes burning, face and neck felt flushed, tachycardia (her watch kept alarming 119-135), weak, hot flashes, cramping, joints hurt, her hands and & feet were so cold they hurt (like when holding snow with bare hands), anxiety, dizzy, her body feels weird, sweating, b/p (blood pressure) low, and throat hurts. There was no treatment given for the events. The patient has not been tested for COVID post vaccination. The patient is recovering from the events. No follow-up attempts are possible. No further information is expected.
41 2021-01-27 heart rate increased 40 min after vaccine, noticed that her throat red, hives, flushed, elevated heart rate to 120s-130s.... Read more
40 min after vaccine, noticed that her throat red, hives, flushed, elevated heart rate to 120s-130s. Took Tylenol and Benadryl which improved. Mild lip tingling. Symptoms now resolved. She believes the heart rate was due to "anxiety" After the first dose, only felt flushed.
41 2021-01-27 chest pain All symtoms were for 45 hours Fever 102 Resting heart rate 125-130 Severe Headache Back Pain Chest p... Read more
All symtoms were for 45 hours Fever 102 Resting heart rate 125-130 Severe Headache Back Pain Chest pain on inspiration Mild shortness of breath Weakness Loss of appitite
41 2021-01-27 chest pain All the following symptoms lasted for 45 hours Fever 102, resting HR 125-130, severe headache, sever... Read more
All the following symptoms lasted for 45 hours Fever 102, resting HR 125-130, severe headache, severe back pain, muscle aches, chest pain on inspiration, weakness, mild nausea with loss of appitite.
41 2021-01-27 chest pain Chest pain (left side) when breathing, flushing, dizziness, and difficulty breathing. BP within norm... Read more
Chest pain (left side) when breathing, flushing, dizziness, and difficulty breathing. BP within normal limits. Patient stabilized and left for home.
41 2021-01-27 low platelet count, platelet count decreased neutropenia & thrombocytopenia
41 2021-01-27 heart rate increased rapid heart rate and racing thoughts; rapid heart rate and racing thoughts; This is a spontaneous re... Read more
rapid heart rate and racing thoughts; rapid heart rate and racing thoughts; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received the first dose of BNT162B2 (Lot number: EL3246), via an unspecified route of administration on 14Jan2021 08:00 at single dose in the left arm for COVID-19 immunization. Medical history included peptic ulcers and acid reflux. Concomitant medication included sucralfate (CARAFATE) and esomeprazole sodium (NEXIUM). On 14Jan2021 09:00, the patient experienced rapid heart rate and racing thoughts. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of rapid heart rate and racing thoughts includes Benadryl. The outcome of the events was unknown.
41 2021-01-28 hypertension 1/27/2021 09:52:40 AM > Patient c/o dizziness and lightheadedness, BP 100/80, P 89, O2 99, states sh... Read more
1/27/2021 09:52:40 AM > Patient c/o dizziness and lightheadedness, BP 100/80, P 89, O2 99, states she is hypertensive with a normal BP of 130/80's , Juice and cookies given with additional observation time. 1000: BP 120/62 with patient still c/o dizziness, will continue to monitor. 1015: BP 130/82, patient states dizziness has improved slightly and that she has a ride and not driving, nurse encouraged patient to go to the nearest ER if symptoms persist. RN 1/28/2021 01:58:49 PM > contacted patient to f/u, message left
41 2021-01-28 heart rate increased This is a spontaneous report from a contactable consumer. A 41-year-old female patient received her ... Read more
This is a spontaneous report from a contactable consumer. A 41-year-old female patient received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EJ1685) on her left arm, via an unspecified route of administration on 08Jan2021 11:00 at a single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included spironolactone, loratadine (CLARITIN) and fish oil. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 19Dec2020 (first dose). The patient experienced severe chills with body shaking for 6 hours, excruciating headache, fever, sore throat, nausea and excessively high resting heart rate (over 100- usually under 60); all on 08Jan2021 20:30. No treatment was received for the events. The outcome of the events was recovered on 09Jan2021 02:30.
41 2021-01-29 blood pressure increased Elevated blood pressure, fever, malaise, headache, dizziness, loss of appetite, abdominal pain. all ... Read more
Elevated blood pressure, fever, malaise, headache, dizziness, loss of appetite, abdominal pain. all of these symptoms came on gradually and worsened 20 hrs after vaccination. symptoms lasted a full 48hrs for me and slowly dissipated over the following days. Itching at injection site started 72hrs after and has now ceased
41 2021-01-31 chest pain red and hot area approximately 2 1/2 X 1 1/2 inches distal to injection site; red and hot area appro... Read more
red and hot area approximately 2 1/2 X 1 1/2 inches distal to injection site; red and hot area approximately 2 1/2 X 1 1/2 inches distal to injection site; Severe pain from neck to hand, shoulder blade to chest (right side); Severe pain from neck to hand; severe pain from neck to hand, shoulder blade to chest (right side); unable to lift arm above shoulder; second dose received on 12Jan2021; first dose received on 18Dec2020; Chills; fatigue; hive; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), intramuscular (right arm) on 12Jan2021 (14:00) at single dose for Covid-19 immunization. The patient received the first dose of BNT162B2 (lot number: unknown) intramuscular (right arm) on 18Dec2020 for Covid-19 immunization. Medical history included "known allergies". The patient's concomitant medications were unspecified (received in 2 weeks). The patient was not diagnosed with COVID-19 prior to vaccination. The patient is not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 12Jan2021 (pending clarification), the patient experienced chills, fatigue, and hive. On 13Jan2021 (07:00), the patient experienced severe pain from neck to hand, shoulder blade to chest (right side) and unable to lift arm above shoulder, and hive. On 14Jan2021 (pending clarification), the patient experienced red and hot area approximately 2 1/2 X 1 1/2 inches distal to injection site. There was no treatment received for the adverse event. The outcome of events was not recovered. The patient has not been tested for COVID-19 since the vaccination. Information on the Batch/Lot number has been requested.
41 2021-02-03 loss of consciousness Pt. stated that she received the COVID vaccine on 1/20/21. On 1/21/21 she felt tired, had loss of a... Read more
Pt. stated that she received the COVID vaccine on 1/20/21. On 1/21/21 she felt tired, had loss of appetite. She reported that she went to a store, and apparently "passed out." Employees of the store told her that she had a seizure. Pt. was transported to local ER, where she states that she had a CT of brain, blood work and was told "everything is normal." Stated that she had COVID testing both in the ER and at work, both reportedly negative. This clinic, has thus far been unable to obtain the individuals medical records from the ER. When seen in our clinic on 2/3/21, pt. stated that she is feeling better, but fatigued. No other loss of consciousness reported by pt.
41 2021-02-03 chest pain Woke up 7:15 am with Headache, chills, fever of101.4, body aches, joint pains, fatigue and on/off ch... Read more
Woke up 7:15 am with Headache, chills, fever of101.4, body aches, joint pains, fatigue and on/off chest pain. Body aches and fever/chills resolved by 1pm and chest pains/joint pains and fatigue and on/off chest pains continued longer Treatment bed rest/Ibuprofen 600 mg x 2 doses
41 2021-02-04 blood pressure increased I felt like I was about to pass out within 10 minutes. I stood up and continued to feel like I was a... Read more
I felt like I was about to pass out within 10 minutes. I stood up and continued to feel like I was about to pass out. I felt more comfortable staying at work where I could get immediate help. I had an extreme case of brain fog. That lasted about 3 hours. I started to have the feeling that you get when your limb is asleep. On day 4, I started to exhibit the symptoms again. I felt like I do when I have thyroid issues, so I went to see my endocrinologist, but he didn't do anything. I did have labs done. I started having blood pressure increases as well. I haven't been able to work out like usual since the vaccine and my sleep has been very poor. I wake up in the middle of the night and am unable to go back to sleep. I am now on heart medication, which is what I was taking previously for thyroid flare ups. I go back to see my endocrinologist in March.
41 2021-02-04 blood pressure increased, fast heart rate Systemic: Other- tachycardia, elevated bp, radiating sensation, panic-Severe
41 2021-02-05 fast heart rate Patient felt tightness and "tingly" in her throat about 15 minutes after vaccination. Hx of tachyca... Read more
Patient felt tightness and "tingly" in her throat about 15 minutes after vaccination. Hx of tachycardia after first dose - discussed with PCP who indicated unsure if this was a reaction or not. However, PCP felt pt should go ahead and take the second dose. Pt's baseline HR is around 66. HR taken - 73. Patient said it felt like pins on her tongue. Drank one bottle of water, denied SOB or throat issues. HR monitored for another 30 minutes and returned to baseline. Patient had another bottle of water and tinglyness dissipated. Declined to go to ED for further evaluation, and said she would follow up with PCP if she noticed any further issues.
41 2021-02-06 fast heart rate Within ten mins, had a flare of pots and vestibular issues i e. Tachycardia, dizziness, ataxia, head... Read more
Within ten mins, had a flare of pots and vestibular issues i e. Tachycardia, dizziness, ataxia, headache, tremors in neck overall difficulty with balance. Have had similar symptoms with antibiotic use.
41 2021-02-08 loss of consciousness I immediately felt nauseated and fatigued, but severe reaction occurred at 10 pm. Extreme weakness a... Read more
I immediately felt nauseated and fatigued, but severe reaction occurred at 10 pm. Extreme weakness and tingling on lips and tongue with difficulty breathing. Migraine and body aches not resolved with OTC meds. Lower back pain was notable and prevented me from sleeping. I passed out in the bathroom when trying to get Tylenol.
41 2021-02-09 heart rate increased Fatigue; dizziness; weakness; increased heart rate; This is a spontaneous report from a contactable ... Read more
Fatigue; dizziness; weakness; increased heart rate; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3302), via an unspecified route of administration on 20Jan2021 at single dose in left arm for COVID-19 immunisation. The patient was vaccinated at Nursing Home/Senior Living Facility. Patient age at vaccination was 41 Years. No other vaccine was given within 4 weeks prior to the COVID vaccine. Medical history included fibromyalgia, Hashimoto's Thyroditis, allergy to Penicillin. Concomitant medications included ibuprofen (IBUPROF), loratadine (CLARITIN), sambucus nigra extract (SAMBUCOL), fluticasone propionate (FLONASE), and multivitamin. On 21Jan2021 the patient experienced fatigue, dizziness, weakness, increased heart rate, all reported as non serious. No treatment was received for the events. The events had not resolved. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19.
41 2021-02-09 heart rate increased, chest discomfort Heaviness in chest; Racing heartbeat; Fatigue; This is a spontaneous report from a contactable other... Read more
Heaviness in chest; Racing heartbeat; Fatigue; This is a spontaneous report from a contactable other hcp (patient). The 41-years-old female patient (not pregnant) received bnt162b2 (BNT162B2), via an unspecified route of administration on 13Jan2021 10:15 in Left arm at single dose for covid-19 immunisation. Medical history included none. No other vaccine in four weeks, no other medications in two weeks, increased protein. No covid prior vaccination. No covid tested post vaccination. No Known allergies. The patient's concomitant medications were not reported. The patient experienced Heaviness in chest, racing heartbeat, fatigue on 22Jan2021. No treatment received. The outcome of the events was not recovered. No follow-up attempts are possible, information on batch number cannot be obtained.
41 2021-02-09 heart rate increased heart started beating fast; lumps grow up on my arm; short of breath; kind of weak; uncomfortable fe... Read more
heart started beating fast; lumps grow up on my arm; short of breath; kind of weak; uncomfortable feeling; This is a spontaneous report from a Pfizer sponsored program. A contactable nurse (patient) reported a 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284) via unspecified route on right deltoid single dose for COVID-19 immunization on 03Jan2021, at 41-year-old. No medical history. Concomitant medication was reported but unspecified. After the patient had received the shot (Jan2021), her heart started beating fast, felt lumps grow up on her arm and became little short of breath. That went away rather quickly, about within 3 hours and the patient was still kind of weak and just uncomfortable feeling. Action taken for BNT162B2 was not applicable. Outcome of the events heart started beating fast, lumps grow up on her arm, short of breath was resolved in Jan2021; outcome of the other events was unknown. Causality assessment per the reporter was checked as yes.
41 2021-02-10 loss of consciousness, fainting Fainted; blacked out; This is a spontaneous report from a contactable nurse (patient). A 41-year-old... Read more
Fainted; blacked out; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1283), intramuscular on 27Jan2021 10:15 at a single dose on right arm for COVID-19 immunization. Medical history included low iron. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination. The patient had no allergies to medications, food or other products. Concomitant medications included ferrous sulfate, vitamin c [ascorbic acid] (VITAMIN C), chondroitin sulfate, glucosamine sulfate (GLUCOSAMINE CHONDROITIN SULFATE). The patient previously received first dose of BNT162B2 on 06Jan2021 for COVID-19 immunization (brand: Pfizer, lot number: EK9231, administration time: 04:30 PM, route: intramuscular, vaccine location: right arm, dose number: 1). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 27Jan2021 23:45, the patient fainted and blacked out. No treatment was given for the adverse events. The events resulted in doctor or other healthcare professional office/clinic and emergency room/department or urgent care visits. It was unknown if the patient has been tested for COVID-19 since the vaccination. The patient was recovering from the events.; Sender's Comments: Based on the compatible time association, the events fainted and blacked out are possibly related to suspect vaccine BNT162B2 administration.The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
41 2021-02-16 chest discomfort Became extremely confused and felt a pressure on my chest. Was not going away after 30 minutes. Vita... Read more
Became extremely confused and felt a pressure on my chest. Was not going away after 30 minutes. Vitals were erratic but within normal perimeters. Was sent to the ED to monitor. The second day was washed out and felt sick but nothing else was needed.
41 2021-02-16 chest discomfort Fatigue; fever; vomiting; pain and swelling at injection site; pain and swelling at injection site; ... Read more
Fatigue; fever; vomiting; pain and swelling at injection site; pain and swelling at injection site; bone and muscle aches throughout body; bone and muscle aches throughout body; headaches; nausea; painful lump on under arm of the arm that the shot was given; trouble breathing; chest heaviness; This is a spontaneous report from a contactable other health professional (patient). A 41-year-old female patient (pregnant: unknown) received bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, , Formulation: Solution for injection, Lot number: unknown, expiration date unknown), via intramuscular on the left arm on 04Feb2021 at 11:30 at a single dose for COVID-19 immunization in the hospital. Medical history included diverticulosis and COVID-19 (Prior to vaccination, was the patient diagnosed with COVID-19). The patient concomitant medications were not reported. The patient experienced fatigue, fever, vomiting, pain and swelling at injection site, bone and muscle aches throughout body, headaches, nausea, painful lump on under arm of the arm that the shot was given, trouble breathing, chest heaviness all on 04Feb2021 at 19:00 PM. Patient visited emergency room/department or urgent care in response to the events. Patient received Zofran, dexamethasone and espi. The reporter assessed the events as non-serious. The patient was recovering from the events. Information on the lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
41 2021-02-16 deep vein blood clot, blood clot Noticed swelling in my left hand around Feb 6th, but by Feb 13th entire left arm was swollen and war... Read more
Noticed swelling in my left hand around Feb 6th, but by Feb 13th entire left arm was swollen and warm and observed blue/purple skin coloring on upper arm and lower arm was red. Went to ER on Feb 15th, and ultrasound revealed a blood clot near the junction of the subclavian vein and cephalic veins. Diagnosis was idiopathic subclavian deep vein thrombosis (DVT). Started on enoxaparin and warfarin on Feb 15th. Referred to hematology and coumadin clinic to monitor INR.
41 2021-02-21 fast heart rate Dizziness, not responsive to questions, tachycardia. RRT called and taken to ER but regained normal ... Read more
Dizziness, not responsive to questions, tachycardia. RRT called and taken to ER but regained normal mentation within minutes and discharged without further treatment. History of similar responses to flu vaccine.
41 2021-02-21 fast heart rate Flushing, tachycardia, lip tingling
41 2021-02-21 palpitations Racing heart for up to 8 hours over 152 pulse started 30 min after injection
41 2021-02-21 deep vein blood clot deep vein thrombosis in lower left leg; mild fever; fatigue; body aches all in the day following inj... Read more
deep vein thrombosis in lower left leg; mild fever; fatigue; body aches all in the day following injection DVT persists and was diagnosed 6 days later; all other symptoms resolved within 24 hours
41 2021-02-22 loss of consciousness, pallor Anaphylactic shock? Shortly after receiving the vaccine my arm was sore and I had a severe headache.... Read more
Anaphylactic shock? Shortly after receiving the vaccine my arm was sore and I had a severe headache. Approximately 24-48 hours after I received the vaccine I started developing a red, hot, itchy raised rash on my ears and buttocks which became more prevalent and peaked around 80-90 hours later. Approximately 82 hours after I received the vaccine, I began to feeI nauseous, dizzy, and fatigued so I stood up to get ready for bed early. While brushing my teeth, I went pale white and felt like I was going to vomit. I put the toothbrush down and got on floor. My pulse felt like it had stopped. I tried to check my pulse and I could only detect one beat every other second. I called for my spouse and by the time he got to bathroom I was passed out. I came back to after about 30 seconds and was convulsing from chills. He put a blanket on me and grabbed my Apple Watch to try to get my pulse which read in the 50s (so I assume it was much lower when I passed out). My hands and feet were tingly and I stayed on the floor until my pulse got back up. I then had diarrhea. At this point in time the rash was most prevalent and was present mostly on my buttocks but also on my ears, scalp, pointer finger on right hand, thighs, and hips. I went to doctor the following morning an my vitals, blood sugar, EKG, urine screen were stable and indicated no issues. 106 hours later I still have the rash on all areas mentioned and am dizzy, nauseous, and fatigued.
41 2021-02-22 fainting Vomiting fainting fever
41 2021-02-24 lightheadedness COVID-19 Vaccine
41 2021-02-25 heart rate increased 12 hours post dose 2 covid vaccine, patient had high heart rate to 160 and temp of 101 and diaphores... Read more
12 hours post dose 2 covid vaccine, patient had high heart rate to 160 and temp of 101 and diaphoresis
41 2021-02-25 palpitations Palpitations, swollen lymph nodes under my left armpit and general malaise the day after the vaccine
41 2021-02-25 fast heart rate, heart rate increased Within 45 mins of the first injection I felt dizzy and not myself. That night I had severe fatigue, ... Read more
Within 45 mins of the first injection I felt dizzy and not myself. That night I had severe fatigue, body aches, chills, and headache. I woke the following day with severe fatigue, headache and tachycardia. Five days out I had muscle twitching and lymphadenopathy. I had tachycardia with heart rate in 120-130s at rest and higher with exertion. I had sustained tachycardia for a solid two days and then intermittently for five days.
41 2021-02-26 heart rate increased Significant lightheadedness, multiple spikes in heart rate
41 2021-02-26 fainting patient that fainted today. She reported on her screening questionnaire of passing out after receiv... Read more
patient that fainted today. She reported on her screening questionnaire of passing out after receiving a injection. She was placed for 30 minute observation. The patient fainted several minutes after being seated. It was observed that she fell over from the chair and hit her head. Patient denied any symptoms other than her right toe being sore.. A + O x 4 medically stable. VS stable. EMS was dispatched due to patient hitting her head and c/o feeling dizzy still...however, patient declined services. She was with her husband and he agreed to drive her home.
41 2021-03-01 chest pain, chest discomfort Pfizer-BioNTech COVID-19 Vaccine EUA: The patient reported to have received 2nd Pfizer COVID-19 vac... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA: The patient reported to have received 2nd Pfizer COVID-19 vaccine on 2/19/21. Unknown where the patient got their vaccine administered. Immediately afterwards, the patient developed hives, cough, and lightheadedness and was sent to Hospital. They were treated with steroids and diphenhydramine. Their symptoms resolved and they were discharged. On 2/20/21 patient came to emergency room in the morning with allergic reaction. They woke up in the morning with hives, swelling in face, and feeling of thickness in throat and shortness of breath. They were given dexamethasone, diphenhydramine, and famotidine. Their symptoms resolved and they were discharged. While at home the patient developed hives and took diphenhydramine. They had tingling and a rash over their face. On 2/20/21 the patient returned to the emergency room in the evening with a rash. The symptoms were pain and burning. They also complained of abdominal cramping, mild nausea, and left sided chest pain. Their symptoms improved and they were discharged. On 2/22/1 the patient returned to the emergency and was subsequently hospitalized. They presented with face swelling, general pruritus, and hives. She reported chest tightness and paresthesia involving her lips. Admitted on 2/22/21 to 2/25/21. She was given diphenhydramine, famotidine, and hydrocortisone.
41 2021-03-02 chest pain, palpitations Tongue swelling and palpitations and difficulty with speech and swallowing, and throat tightness. o... Read more
Tongue swelling and palpitations and difficulty with speech and swallowing, and throat tightness. onset within 30 minutes of vaccines. taken to Urgent care, received epinephrine injection, then transferred by ambulance to Hospital ER. given IV diphenhydramine and IV decadron. chest pain. normal ECG and troponin. They did not check tryptase.
41 2021-03-02 heart rate increased face started to feel "hot and on fire"; face and neck turned bright red; face started to feel really... Read more
face started to feel "hot and on fire"; face and neck turned bright red; face started to feel really tight; Heart Rate then was elevated to 115 bpm; shortness of breath; itchy eyes; headache; nausea; Arm still felt sore; fatigued; At site of injection there was a warm sensation; metallic taste in my mouth; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262) solution for injection, intramuscular at left arm on 29Jan2021 at 10:30 AM at single dose for COVID-19 immunization. Medical history included asthma. The patient has no known allergies. The patient's concomitant medications were not reported. The patient was not pregnant and has no other vaccines in four weeks. She will have a birth control in two weeks. It was unknown if the patient has COVID prior to vaccination. She was not tested with COVID post vaccination. The patient was given COVID-19 vaccine at a hospital. When she initially received the vaccine on 29Jan2021, the site of injection had a warm sensation which resolved within a minute. Then on the ride home, she had a metallic taste in her mouth. While at home around 4:00 PM, her face started to feel hot and on fire and then her face and neck turned bright red. Her face started to feel really tight and hot. Heart rate was then elevated to 115 bpm. She then started having shortness of breath, itchy eyes, headache and nausea. The patient sat down and took 10 mL of BENEDRYL (as reported) at 4:30 PM or 4:40 PM. Between 5:00 PM and 7:00 PM, her face and neck were still slightly red. Her arm felt sore and she was fatigued. She again took 10 mL of BENEDRYL at 7:30 PM. She woke up on 30Jan2021 and still felt fatigued and the back of arm (tricep area) was very sore. The patient also took paracetamol (TYLENOL) 600 mg. The outcome of the event vaccination site warmth was recovered with sequel on 29Jan2021 and recovered with sequel on Jan2021 for all other events.
41 2021-03-02 heart rate increased heart rate suddenly increased; throat felt tight; felt very warm in the head and neck like was flush... Read more
heart rate suddenly increased; throat felt tight; felt very warm in the head and neck like was flushed; felt very warm in the head and neck like was flushed; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL9265) via an unspecified route of administration in the left arm on 30Jan2021 10:30 am at a single dose as Covid vaccine. Medical history included known allergies to penicillin- anaphylaxis. There were no concomitant medications (no other vaccine in four weeks and no other medications in two weeks). Approximately 5 minutes after injection, heart rate suddenly increased and throat felt tight, and felt very warm in the head and neck like was flushed on 30Jan2021 10:45 am. It passed after a minute or two, then happened again around five times within the hour after injection. No treatment was provided for the events. The patient had no Covid prior to vaccination and has not had Covid tested positive post vaccination. The outcome of the events was recovered on Jan2021.
41 2021-03-03 fainting After receiving the vaccine, patient experienced nausea with an episode of syncope. SBP 60 mmHg prio... Read more
After receiving the vaccine, patient experienced nausea with an episode of syncope. SBP 60 mmHg prior to syncope. Patient was given epinephrine 0.3 mg IM x1 dose. Patient was difficult to arouse and a second epinephrine 0.3 mg IM was administered! EMS was called on seen and patient was taken to the ER where patient received fluids and zofran and was discharged. Husband confirmed the patient has phobia for shot/needles.
41 2021-03-03 chest pain Pt developed a few hive-like lesions on her legs on 1/28/2021, 2 days following first COVID vaccinat... Read more
Pt developed a few hive-like lesions on her legs on 1/28/2021, 2 days following first COVID vaccination. Over the next 2 days developed more. Each lasted less than 24 hrs, but some lesions were always present. No other symptoms. Allegra resolved hives. On 1/17/2021 after second COVID vaccination, she developed headache, body aches, and low grade fever lasting 1 day. Three days later, hives returned, worse than with first vaccination. Allegra resumed up to qid. On 2/23/2021 developed severe chest pain, waxed and waned through night, resolved by next morning. Was hive-free between 2/24 and 2/28 when the hives recurred. Has had two bouts of lip swelling. Hives persist, despite antihistamine use, to the present.
41 2021-03-03 heart rate increased sudden onset of rapid heart beat lasting up to 10 mins at a time with HR as high as 110 when laying/... Read more
sudden onset of rapid heart beat lasting up to 10 mins at a time with HR as high as 110 when laying/resting. Over the course of the last 5 weeks it has lessened in severity
41 2021-03-04 palpitations About an hour after the Covid vaccine was given I experienced heart racing very rapidly, wave of nau... Read more
About an hour after the Covid vaccine was given I experienced heart racing very rapidly, wave of nausea, feeling faint, knot in throat, this last about 5-10 minutes then passed, had knot in throat x 2 days.
41 2021-03-07 pallor, heart rate increased Severe stomach cramping; diarrhea; dizzy; nausea; cold clammy pale skin; cold clammy pale skin; swea... Read more
Severe stomach cramping; diarrhea; dizzy; nausea; cold clammy pale skin; cold clammy pale skin; sweating profusely; very low body temp; rapid pulse; shaking; This is a spontaneous report from a contactable consumer who reported for herself. A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL3249, via an unspecified route of administration in the left arm on 02Feb2021 04:00 PM at a single dose for covid-19 immunisation. Medical history included obesity. Patient was not pregnant at the time of vaccination. The patient has no allergies to medications, food, or other products. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. On 02Feb2021 at 10:00 PM (6 hours after vaccine was given), the patient experienced severe stomach cramping, diarrhea, dizzy, nausea, cold clammy pale skin, sweating profusely, very low body temp, rapid pulse, and shaking. No treatment was received for the adverse events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was unknown.
41 2021-03-17 fainting, palpitations sore throat; nausea; palpitations; headaches; Dizziness; fatigue; faint; body aches; myalgia; cough;... Read more
sore throat; nausea; palpitations; headaches; Dizziness; fatigue; faint; body aches; myalgia; cough; This is a spontaneous report from a contactable nurse. A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose on 07Jan2021, 15:00 (lot number: EL3246), via an unspecified route of administration in the left arm at single dose for COVID-19 immunization in the hospital. The patient's medical history included Covid-19 prior to vaccination. The patient had no known allergies. The patient's concomitant medications were not reported. The patient did not receive other vaccines within four weeks. The patient was not pregnant at the time of vaccination. The patient experienced sore throat, nausea, palpitations, headaches, dizziness, fatigue, faint, cough, body aches and myalgia on 08Jan2021, 19:00. The adverse events required doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care and disability or permanent damage. The patient received treatment including antibiotics (did not help); pain medications for myalgia. The patient was underwent COVID-19 (Nasal Swab) on 15Jan2021 which was negative, and PCR and Flu (nasal swab) test on 20Jan2021 which was negative. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the compatible temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
41 2021-03-31 fast heart rate Anaphylactic reaction; Tachycardia/she felt her heart going fast; her throat starting to close/ Sens... Read more
Anaphylactic reaction; Tachycardia/she felt her heart going fast; her throat starting to close/ Sensation of throat closure; Upper airway swelling/Increased use of accessory respiratory muscles; she could not breath/Difficulty breathing (without wheeze or stridor); Respiratory distress; her lips and tongue were big and it was getting worse; her lips and tongue were big and it was getting worse; Hoarse voice; Shock; Decreased level of consciousness; Generalized prickle sensation; Red and itchy eyes; Red and itchy eyes; Abdominal pain; The initial case was missing the following minimum criteria: adverse event (unspecified). Upon receipt of follow-up information on (17Mar2021), this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered on arm right on 25Feb2021 08:15 (Batch/Lot Number: EN6203) as SINGLE DOSE for COVID-19 immunization at the hospital. Medical history included asthma. It was reported that the patient was allergic to NSAID, paracetamol (TYLENOL), pollen, cats and dogs; and insect bite/sting. She also had environmental allergies. It was also reported that her sister had breast cancer. Ongoing concomitant medications included spironolactone (SPIRONOLACTONE), vitamin C, cyanocobalamin (VITAMIN B12), calcium (CALCIUM), magnesium (MAGNESIUM), iron (IRON) and zinc (ZINC) all taken for unknown indications since unknown date. She had no other vaccines received around the time of COVID-19 vaccine vaccination. The patient was not pregnant (including at the time of vaccination). The patient received the first dose of PFIZER-BIONTECH COVID-19 VACCINE on 25Feb2021 at 08:15 AM. Thirty minutes after the vaccination (at 08:45), she had an anaphylactic reaction as she felt her heart going fast and was noted to have tachycardia (as an organ involvement), had sensation of throat closure her throat starting to close. She had upper airway swelling with increased use of accessory respiratory muscles, respiratory distress as she could not breath (without wheeze or stridor). Her lips and tongue were big and it was getting worse. She also had the following organ involvements manifested by hoarse voice, shock, decreased level of consciousness, generalized prickle sensation, red and itchy eyes, and abdominal pain. She was administered with diphenhydramine (BENADRYL) IV. She was taken to ER and was also administered with famotidine 20 mg. The events were considered life threatening. The patient recovered from the events on unknown date in 2021.
41 2021-04-01 loss of consciousness started feeling tired/she was starting to feel tired, then really tired and the mom said 'maybe you ... Read more
started feeling tired/she was starting to feel tired, then really tired and the mom said 'maybe you should pull over' and she didn't have time to process it as she fainted/blacked out right after; fainted/blacked out right after; she rear ended another car and then drove around that car and she think the car stopped itself possibly not sure but when she awoke she was directly in front of the vehicle she had rear ended; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that a 41-year-old female patient received dose 1 bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm on 16Mar2021 16:00 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization . There were no patient's medical history and concomitant medications. The patient waited the 15 minutes at the site and felt fine. She got on the road at 6pm and started feeling tired. She was on the phone with her parents and mentioned she was starting to feel tired, then really tired and the mom said 'maybe you should pull over' and she didn't have time to process it as she fainted/blacked out right after. When she woke up, she was still behind the wheel the drivers steering wheel airbag and airbag at her legs had deployed. She has no memory of what happened but her daughter (age 9) was in the back seat of the car with the dog. The patient's daughter said that she accelerated into the intersection passed through ("I blacked out as the light was changing to green") she rear ended another car and then drove around that car and she think the car stopped itself possibly not sure but when she awoke she was directly in front of the vehicle she had rear ended. The driver in the other car was taken in an ambulance with she believes the other driver had some discomfort in the neck/back but she was not 100% sure. It was reported that the outcome of events was recovering. It was unknown if the patient receive treatment for the events. The events were considered as serious due to hospitalization. Information on the lot/batch number has been requested.
41 2021-04-12 blood clot Delivered preterm infant (stillbirth) at 24 weeks on March 9, 2021. Infant had IUGR noted at 19 we... Read more
Delivered preterm infant (stillbirth) at 24 weeks on March 9, 2021. Infant had IUGR noted at 19 weeks. Placenta showed 2 blood clots restricting blood flow at delivery. Mother with no known clotting disorders. 2 prior healthy infants.
41 2021-04-13 chest pain, pulmonary embolism Shortness of breath and chest pain 4/9/21 Went to ER on 4/9/21 Diagnosed with Multiple Pulmonary Emb... Read more
Shortness of breath and chest pain 4/9/21 Went to ER on 4/9/21 Diagnosed with Multiple Pulmonary Embolisms in both lungs; transferred via ambulance as medical emergency to another hospital for treatment Released from hospital on 4/11/21 and currently under treatment
41 2021-04-16 chest discomfort Throat was "thick"; Difficulty breathing; Entire body tingling; Facial numbness; Throat clearing occ... Read more
Throat was "thick"; Difficulty breathing; Entire body tingling; Facial numbness; Throat clearing occurred; Severe Allergic Reaction to Vaccine; Chest pressure; This is a spontaneous report from a contactable consumer (patient reporting for herself). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Dose 1) via an unspecified route of administration, in the left arm on 20Mar2021, 10:15AM (batch/lot number: ER2613) at 41 years old at a SINGLE DOSE for COVID-19 immunization. The vaccine was administered at a Public Health Clinic. The patient's medical history included rheumatoid arthritis from an unknown date and unknown if ongoing. Patient was not pregnant at the time of vaccination. Concomitant medications were not reported. The patient had previous allergy to Rituxin. The patient did not receive any other medications within two weeks of vaccination. Patient did not receive other vaccination within 4 weeks prior to the BNT162B2. Patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. On 20Mar2021 10:15, the patient experienced severe allergic reaction to vaccine (allergy to vaccine). It was reported that after 15 minutes (at 10:30), throat clearing occurred (throat clearing). After 25 minutes (at 10:40), throat was "thick"; patient experienced difficulty breathing (dyspnoea), entire body tingling (paraesthesia), and facial numbness (hypoaesthesia). EPI was administered at the site, patient was transported by ambulance to ER where steroids and other medicines were administered. The patient remained there until evening. Patient still have to take medications and her doctors have no idea when symptoms including chest pressure (chest discomfort), breathing difficulty, facial numbness and tingling will subside. Patient was on hold with Pfizer's vaccine line for 1 hour 45 minutes and was then cut off. Patient demanded some answers. Therapeutic measures were taken as a result of the events which included continuing multiple medications. The events resulted in ER visit/ urgent care and Doctor or other healthcare professional office/clinic visit. Patient was recovering from the events. Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the available information, close temporal association and known product profile, a possible causal relationship cannot be excluded between the suspect product bnt162b2 and all reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
41 2021-04-19 heart rate increased Nausea, severe rashes (hives) red and burning and itchy throughout the body, second high fever that... Read more
Nausea, severe rashes (hives) red and burning and itchy throughout the body, second high fever that went up to 102.1 followed by chills and body ache, light headed ness and headache. Rashes occurred 10-12hrs after vaccine and got worse till was treated at a medical clinic and er. Had heavy heart rate of 120+ IV administered with diphenhydramine which is continued even now as slight rashes still exists and prednisone was given on Sunday April 19 2021 at 11:50am Later since rashes still persisted was advised by the urgent clinic to go to ER where hydroxyzine was given
41 2021-04-20 chest discomfort, chest pain, palpitations Heart was racing/ pounding heart; chest pain; chest pressure; shortness of breath; heart palpitation... Read more
Heart was racing/ pounding heart; chest pain; chest pressure; shortness of breath; heart palpitations and fluttering; Two EKGs have shown shortened PR interval of 110; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number not reported) via an unspecified route of administration, administered in Arm Left, at the age of 41-year-old, on 26Mar2021 11:45 as SINGLE DOSE for covid-19 immunisation. Medical history included Pituitary adenoma, seasonal and penicillin allergy. The patient is not pregnant at the time of vaccination. The patient was not diagnosed nor tested for COVID prior vaccination. Concomitant medication included fluticasone propionate (FLONASE). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number not reported), via an unspecified route of administration, administered in Arm Left on Mar2021 as SINGLE DOSE for covid-19 immunisation; and Amoxycillin and Clindamycin and experience allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 26Mar2021 at 12:15pm, her heart was racing about 30 minutes following vaccination. The patient felt pounding heart throughout the night as well as chest pain and pressure. Over the next several days in 2021, the patient felt heart palpitations and fluttering, intermittent chest pain, and shortness of breath. Two EKGs in 2021 have shown shortened PR interval of 110. No other testing has been done. The patient is currently wearing a Ziopatch. The patient did not receive treatments and required physician office visit in response to the events. Outcome was recovering at the time of the report. Information on the lot/batch number has been requested.
41 2021-04-21 heart rate increased - Almost immediate pain at injection site that moved around my arm, into my armpit, arm felt heavy -... Read more
- Almost immediate pain at injection site that moved around my arm, into my armpit, arm felt heavy -Rapid heartbeat 5-10 minutes after injection, along with dizziness, rapid pulse and nausea that lasted approximately 5 minutes -After than, body aches, nausea, arm pain and tiredness -Nausea, exhaustion, arm pain and body aches for 48 hours following injection -Started monthly period early, 4 days following vaccine, period started heavier than normal (started my period 1 week early which is VERY unusual for me) -Some of my vaccine reactions felt exactly like a condensed and much stronger version of PMS
41 2021-04-24 pulmonary embolism, deep vein blood clot DVT; multiple bilateral pulmonary embolisms; rash; hives on my lower abdomen; calf injury due to ext... Read more
DVT; multiple bilateral pulmonary embolisms; rash; hives on my lower abdomen; calf injury due to extreme pain that felt like a constant cramp; This is a spontaneous report from a contactable Other HCP (patient) . A 41-years-old no pregnant female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 19Jan2021 16:30 (Batch/Lot Number: EL1283) as SINGLE DOSE for covid-19 immunisation.Age at vacciantion:41 years. No other vaccine in four weeks. No COVID prior vaccination Medical history included type 1 diabetes mellitus from an unknown date and unknown if ongoing , Hashimoto's Disease from an unknown date and unknown if ongoing. Concomitant medication(s) included metformin (METFORMIN) and levothyroxine (LEVOTHYROXINE) . The patient experienced DVT followed by multiple bilateral pulmonary . The clinical course was reported as follows:"Within 5 hours of the first dose I got a 3" in diameter rash and hives on my lower abdomen, which I reported when receiving my second dose. About a week before the second dose, I self-diagnosed myself with a calf injury due to extreme pain that felt like a constant cramp that lasted until my second dose. After the second dose, I was hospitalized 5 days (16Feb2021-20Feb2021) with multiple bilateral pulmonary embolisms/blood clots in both lungs after being sent to the ER by a nurse practitioner, and told that my previously self diagnosed leg injury was really DVT - I actually left the hospital with one blood clot still in my leg.Hospital's Cardiac ICU by physician's transport because my case was too to be treated at (Withheld). I am lucky to have survived this-please warn people of the symptoms" The patient underwent lab tests and procedures which included antiphospholipid antibodies (unknown date): unknown results (won't be in until mid-Jun because it requires testing 12 weeks apart)-tested negative for genetic conditions that could have caused the clots , sars-cov-2 test: negative on 16Feb2021.The events DVT and pulmonary embolism resulted in Emergency Room visti /Phisician office visit .The event "DVT" was treated with Heparin, still on blood thinner. The patient received the second dose on 08Feb2021 left arm (Lot#BL9269).The outcome of the event DVT was recovering.The outcome of the other events was unkonwn; Sender's Comments: Based on vaccine-event chronological association a causal relationship between events Deep vein thrombosis, Pulmonary embolism and Pain in extremity and BNT162B2 vaccine cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : same report/patient, different dose/AE
41 2021-04-24 fainting Fainting; Nausea; Dizziness; Fatigue; This is a spontaneous report from a contactable consumer (Pati... Read more
Fainting; Nausea; Dizziness; Fatigue; This is a spontaneous report from a contactable consumer (Patient). A 41-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Formulation: Solution for injection, Lot number: EW0162) via unspecified route of administration on arm left at a single dose on 08Apr2021 17:00 for COVID-19 immunization. The patient medical history. Concomitant medication was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 08Apr2021 at 17:15 patient experienced nausea, fainting, dizziness and fatigue. The outcome of the events was recovered on an unspecified 2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
41 2021-04-24 excessive bleeding hemorraging; Period was late; nausea; fatigue; headaches; irregular period; Erythema multiforme majo... Read more
hemorraging; Period was late; nausea; fatigue; headaches; irregular period; Erythema multiforme major; I broke out with multiple sores all over the left Breast; a strange Blister was on my left breast; Pain; This is a spontaneous report from a contactable consumer. A 41-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 08Mar2021 10:00 (Batch/Lot Number: EP6955) as SINGLE DOSE for covid-19 immunisation. The patient has no medical history. Concomitant medication(s) included alprazolam (XANAX). On 08Mar2021 21:00, the patient became sick 11 hours after first dose and was ill for two days took a full week for nausea and fatigue and headaches to improve. On March 19th my period was late and by the 22nd when it started I had to be hospitalized for hemorraging and a strange Blister was on my left breast over the next two weeks I broke out with multiple sores all over the left Breast and still am and was diagnosed with Erythema multiforme major from an autoimmune response to the vaccine. Multiple ER and urgent care visits resulted as I was first misdiagnosed with Shingles. Then, I started bleeding again only 14 days after my period ended again. The pain and bleeding are as intense. I have never had irregular period in my life until the vax. The patient was hospitalized for hemorraging from 22Mar2021 to an unknown date for 1 days. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 31Mar2021 covid test type post vaccination=Nasal Swab, covid Test name post vaccination=Pi xel by lab, covid test date=31Mar2021, covid test result=Negative. The patient did not receive treatment for the events. The outcome of the events hemorraging, Erythema multiforme major, I broke out with multiple sores all over the left Breast, a strange Blister was on my left breast was not recovered, while recovering for the events nausea, fatigue, and headache, and unknown for the rest of the events. The patient second shot on March 29th and the skin lesions and sores continue to appear as well as fatigue, headache and joint pain. I was in good health before receiving the vaccine and never had skin issues or irregular or painful periods with this much bleeding.
41 2021-04-28 pallor, lightheadedness, loss of consciousness Feeling of blacking out; Nauseous/nausea; Light headed; Vision clouded over; Ears started ringing lo... Read more
Feeling of blacking out; Nauseous/nausea; Light headed; Vision clouded over; Ears started ringing loudly; Pale; Vasovagal response; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported), on the left arm on 14Apr2021 (15:15) as a single dose, with route of administration unspecified, for COVID-19 immunization. Medical history included hypothyroidism, allergies and sulfa allergies. The patient was not pregnant at the time of vaccination. Concomitant medication included thyroid (ARMOUR THYROID). On 13Apr2021 (15:15), the patient had a feeling of blacking out; nauseous/nausea; light headed; vision was clouded over; ears had started ringing loudly; was pale; and had vasovagal response. The events had resulted in doctor or other healthcare professional office/clinical visit and emergency room/department or urgent care. The patient had received an anti-nausea medication, fluids and antacids as treatment for the reported events. The patient's bloodwork was fine and vitals were good, both on 13Apr2021. The outcome of the events was unknown. The patient was not diagnosed with COVID-19 prior to the vaccination, and had not been tested post-vaccination. Information on the lot/batch number has been requested.
42 2020-12-31 fainting, loss of consciousness Dizziness, nausea, diaphoresis, syncope/fall. Totally blacked out and fell. Helped back to bed, co... Read more
Dizziness, nausea, diaphoresis, syncope/fall. Totally blacked out and fell. Helped back to bed, covered in sweat. No fever. Layed in bed until next morning around 10am, still dizzy and nauseated.
42 2020-12-31 atrial fibrillation, heart rate increased Rapid heart rate, arrhythmia felt at 7pm 12/30, still present in morning 12/31/20, at 7:00 am was fo... Read more
Rapid heart rate, arrhythmia felt at 7pm 12/30, still present in morning 12/31/20, at 7:00 am was found to be in afib on monitor at work (I am a surgeon). Treated in emergency room after EKG confirmed a-fib. Received potassium and flecainide and converted to normal sinus rhythm after several hours.
42 2021-01-02 fast heart rate, hypertension, palpitations 11:42 am patient felt dizzy and palpitations 10-12 minutes after receiving vaccine. 11:47 am patie... Read more
11:42 am patient felt dizzy and palpitations 10-12 minutes after receiving vaccine. 11:47 am patient evaluated by EMS BP 168/110, Pulse 120, EKG done. patient reporting feeling better but wishes to to seen in ED. 11:54 am patient transported to hospital by EMS
42 2021-01-02 palpitations After receiving vaccine, c/o heart racing, palpitations, pulse- 100-120, hot flash, scratchy throat,... Read more
After receiving vaccine, c/o heart racing, palpitations, pulse- 100-120, hot flash, scratchy throat, c/o "tonsil swelling"....
42 2021-01-03 chest discomfort Developed wheezing/chest tightness. No stridor or rash or injection site symptoms. Took Benadryl 50m... Read more
Developed wheezing/chest tightness. No stridor or rash or injection site symptoms. Took Benadryl 50mg q4 x 3 doses, took albuterol every 2 hrs for 8 hrs. Had EpiPen nearby (a family member's, not mine), but did not use. Felt fine the next morning, 24 hrs afterwards. Just mild headache for a few days (not unusual for me)
42 2021-01-03 blood pressure increased Few minutes after receiving the vaccine I have noticed slight shortness of breath, then after 45 min... Read more
Few minutes after receiving the vaccine I have noticed slight shortness of breath, then after 45 minutes, I developed a headache. These symptoms worsen as the day progressed. The severe headache and increased shortness of breath lasted 14 days along with dangerously elevated blood pressure, fatigue, and nausea.
42 2021-01-03 chest discomfort Patient complained of shortness of breath, chest tightness, and throat closure
42 2021-01-04 palpitations, blood pressure increased About 20-30 after injection it became a bit difficult to swallow. Throat felt thicker; heart felt li... Read more
About 20-30 after injection it became a bit difficult to swallow. Throat felt thicker; heart felt like it was racing. Shivering and Blood pressure was up a little. 14:19 Benadryl 25 mg administered. 14:30 BP 164/92, P-76 R-16 O2 100% Discharged back to work at 16:15.
42 2021-01-04 nosebleed About 45 minutes after injection, got a bloody nose out of no where, then at night started having GI... Read more
About 45 minutes after injection, got a bloody nose out of no where, then at night started having GI symptoms & low grade fever; About 45 minutes after injection, got a bloody nose out of no where, then at night started having GI symptoms & low grade fever; About 45 minutes after injection, got a bloody nose out of no where, then at night started having GI symptoms & low grade fever; This is a spontaneous report from a contactable other healthcare professional (patient). A 42-years-old female patient started to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscularly on 28Dec2020 13:15 (at the age of 42-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included the patient had allergies to medications, food, or other products, Bactrim and Sulfa based medications, & food sensitivities. Concomitant medication included birth control. The patient previously took sulfamethoxazole and trimethoprim (BACTRIM) and experienced allergies to medications: BACTRIM. The most recent COVID-19 vaccine was administered in the hospital. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 28Dec2020 About 45 minutes after injection, patient got a bloody nose out of nowhere (14:00), then at night at 22:00 (10:00PM) started having gastrointestinal (GI) symptoms & low grade fever. The events bloody nose out of nowhere, then at night started having gastrointestinal (GI) symptoms & low grade fever did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. No treatment was received for the events bloody nose out of nowhere, then at night started having gastrointestinal (GI) symptoms & low grade fever. Outcome of the events bloody nose out of nowhere, then at night started having gastrointestinal (GI) symptoms & low grade fever were recovering. Since the vaccination, the patient has not been tested for COVID-19. Information on the lot/batch number has been requested.
42 2021-01-04 palpitations Approximately 6.5hrs after vaccination, patient developed severe fatigue, some palpitations and dizz... Read more
Approximately 6.5hrs after vaccination, patient developed severe fatigue, some palpitations and dizziness. The next the morning, she had headache, nausea and strange feeling on the tip of throat and nose. She also had pain and swelling in the injection side, no erythema.
42 2021-01-05 chest pain 12 hours after injection, developed swelling at injection site that increased over two days to be ab... Read more
12 hours after injection, developed swelling at injection site that increased over two days to be about 1 1/2 inch in diameter that slowly decreased over 1 week. Developed muscle pain in left jaw, left neck, left chest for two days. Itching at site of injection lasted about 2 weeks.
42 2021-01-06 hypotension, fainting 12 minutes post vax felt warm, dizzy, hypotensive, syncope. Transferred to ED, monitored and discha... Read more
12 minutes post vax felt warm, dizzy, hypotensive, syncope. Transferred to ED, monitored and discharged. On 12/24/2020 developed cyanosis to lips. Returned to ED and placed on 5 day steroid therapy and diphehydramine. Mildly improved.
42 2021-01-06 chest pain, chest discomfort, heart rate increased About 5 minutes after the shot, I started to feel a tightness in my throat. It lasted a couple of m... Read more
About 5 minutes after the shot, I started to feel a tightness in my throat. It lasted a couple of minutes and then passed. Then about 45 minutes after I started to feel a heaviness/ache in my upper chest. This feeling continued for days. Around day four I began to have a feeling of great pressure in my throat, particularly when swallowing. I noticed that my heartrate was elevated, but that might have been because the feeling was very stressful. The feeling would increase when I turned my head to the side or put my chin down.This feeling persisted for 3 days. After three days the feeling changed slightly and started feeling more like the sensation one gets when you have food stuck in your throat. As I type this, it is 8 days after the vaccine and I still feel this sensation in my throat.
42 2021-01-06 chest pain, fast heart rate Immediately after the vaccination she experienced chest pain, tachycardia, and throat tightness. She... Read more
Immediately after the vaccination she experienced chest pain, tachycardia, and throat tightness. She was given benedryl and epinephrine and EMS was called.
42 2021-01-06 palpitations Patient stated 15 minutes post vaccination she felt tingling to her right hand for about 4 hours. Re... Read more
Patient stated 15 minutes post vaccination she felt tingling to her right hand for about 4 hours. Reports palpitations 30 minutes post vaccine. Unknown duration as per patient.. Patient denies any palpitations, chest pain, or shortness of breath at time of phone interview. At about 9pm on the day of vaccine patient reports a rash all over her body. Describes it as bumpy and very itchy, getting worse. Patient reports taking Benadryl. States it helped with the itching but rash is continuing to spread. Denies respiratory complaints at time of phone interview. Patient instructed to see her provider as soon as possible for evaluation and treatment.
42 2021-01-07 chest pain 01/07/2021 - Woke up at 10AM with pulsing pains in left side of chest. I took asprin and it went aw... Read more
01/07/2021 - Woke up at 10AM with pulsing pains in left side of chest. I took asprin and it went away. 01/08/2021- Woke up at 11AM with slight pulsing pains again in left side of chest. no medicine taken. It came and went as the day went on - felt similar to heartburn. Thought I should report cause I've never woken up with these pains prior to this.
42 2021-01-07 heart rate increased 1/06/2021: 0200-severe body ache, chills 0700 to 1100- 103.2 temp climbing with use of Tylenol and a... Read more
1/06/2021: 0200-severe body ache, chills 0700 to 1100- 103.2 temp climbing with use of Tylenol and aspirin. 1100 to 01/07/2021, 0200 severe lethargy lasting till around this time. Heart rate excess of 130, dizziness, severe weakness, muscle pain, fever 103 to 104 F. 650mg oral Tylenol and aspirin 325mg every 6 hours does not control temp. Intermittent periods of extreme perspiration. 0200 1/07/2021 to 1200, slow decline in body pain with ongoing Tylenol and aspirin every 6 hours. No more elevated temps. Injection site/arm remains painful.
42 2021-01-07 fainting BP: 120/70 - Lightheadedness, syncope. Outcome: rested, stabilized.
42 2021-01-07 excessive bleeding Bleeding, Myalgia, tingling in the fingers of the right hand; fatigue Immediately upon vaccination -... Read more
Bleeding, Myalgia, tingling in the fingers of the right hand; fatigue Immediately upon vaccination - bleeding at the injection site which the employee reports as filling the bandaid over the site. When she got home in the evening and took it off blood ran down her arm but the bleeding stopped immediately. This has resolved. 12/29 at about 2:00 employee reports onset of tingling in the fingers of her right hand - index, middle, ring, and pinky. For about 2 hours the tingling was intense. As of 12/30 this has markedly improved and the tingling is intermittent. Later in the evening of 12/29 she noticed the onset of muscle pains throughout her body but especially in her feet. She also became very fatigued. These symptoms linger on 12/30. On 1/1 employee reports symptoms muscle soreness had resolved. 1/4 tingling in her fingers/arm has improved but is still present. She will follow-up with her PCP if this symptom persists beyond 2-4 weeks.
42 2021-01-07 blood pressure increased, heart rate increased Chills; Soreness at the injection site; generalized body aches/Body aches; Shortness of breath; Asth... Read more
Chills; Soreness at the injection site; generalized body aches/Body aches; Shortness of breath; Asthma attack; Difficulty sleeping; Light headed and dizzy; Nausea; high BP 140's; HR 110's to 120s; Nasal congestion; Swelling of the face; Sore throat; This is a spontaneous report from a contactable nurse. A 42-years-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EK5730, expiration date not reported), intramuscular on the right arm on 31Dec2020 at 10:15 AM, at a single dose for Covid-19 immunization. Medical history included asthma, allergy, hypothyroidism, and some fish allergy. There were no concomitant medications (no other vaccine in four weeks and no other medications in two weeks). Patient previously took ibuprofen and experienced allergy. The patient is not pregnant. On 31Dec2020, after ten-15 minutes (10:30 AM) of receiving the vaccine, she was light headed and dizzy with some nausea. Monitored in the emergency room (ER) with high BP 140's and heart rate (HR) 110s to 120s. After an hour of saline bolus, she was better but she got nasal congestion and swelling of the face with sore throat. On 01Jan2021, after 24 hours, she got some soreness at the injection site with generalized body aches. Also she got some shortness of breath which lead to her asthma attack and difficulty sleeping. On 02Jan2021, after 48hours, she was feeling still light headed with some sore throat, chills, body aches and severe headache which lead her to go to the ER and got herself tested for flu, covid and strep, which came back all negative but her signs and symptoms (s/sx )still after discharge was getting worst especially the headache and generalized body aches. As well as congestion and sore throat. The patient had given "Ivf" for the events. The patient was not diagnosed with Covid prior to vaccination and was not Covid tested post vaccination. The outcome of the events was not recovered. The reporter assessed the events as non-serious.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation between vaccination and onset of events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
42 2021-01-07 blood glucose increased Headache within 45 min of injection. Nausea and Headache after 24 hours. Currently almost 36 hours l... Read more
Headache within 45 min of injection. Nausea and Headache after 24 hours. Currently almost 36 hours later I am still nauseous. I took Zofran. And extra strength tylenol. My blood sugars are running a little high despite insulin pump and frequent monitoring. No ketones. Temp is 100.
42 2021-01-07 fast heart rate Headache, Myalgia, Fever, Tachycardia, temp 104.0, chills, fatigue Narrative:
42 2021-01-07 palpitations Palpitations. Tingling of lips. Presented to ED. Observed x 4 hours. Patient improved. Discharged t... Read more
Palpitations. Tingling of lips. Presented to ED. Observed x 4 hours. Patient improved. Discharged to PCP if sxs worsen. ED notes incomplete.
42 2021-01-07 blood pressure increased Patient states she became hot and flushed about 2 minutes after receiving vaccine. The right side o... Read more
Patient states she became hot and flushed about 2 minutes after receiving vaccine. The right side of her tongue became tingly. The rapid assessment team responded and noted her blood pressure was 186/103 and pulse was 146 and she had a headache. They had her rest for about 45 minutes and she felt better. Her blood pressure came down to 130/90 and pulse was 100. On 01/07/20 she still is experiencing a headache and body aches. She has never felt short of breath.
42 2021-01-08 fast heart rate, blood pressure increased, chest pain, palpitations, lightheadedness Palpitations, presyncope, tachycardia, elevated blood pressure, sweating, chest pain
42 2021-01-08 heart rate increased Pt noticed that heart rate increased to 112 on watch about 10 minutes after vaccine was given. She ... Read more
Pt noticed that heart rate increased to 112 on watch about 10 minutes after vaccine was given. She also felt dizzy for about 30 seconds but this resolved on its own. Pt reported to staff. Vital signs were taken Temp 97.9, heart rate 84, BP 124/85. Pulse was regular. Pt denied any ongoing dizziness or other symptoms. She was given apple juice and monitored for another 15 minutes with no further symptoms
42 2021-01-09 fast heart rate, palpitations Once injected felt dizzy then sat down, it was hard to breathe I can fell rapid heart palpatiions an... Read more
Once injected felt dizzy then sat down, it was hard to breathe I can fell rapid heart palpatiions and my my body get hot from the inside out. I started sweating and my skin was turning red. I notified staff and they kept me an additional 30 minutes. I started getting hives and my body felt hot. The fire fighters asked the nursing staff for Benadryl they advised they did not carry it and could not give it to me. I carry Benadryl in my work bag due to my list of allergies. Fire assisting at location advised me to take Benadryl. I notified my employer because Benadryl makes me sleepy. They sent me home and I continued Benadryl and missed work for three days. At this time I went to prestige emergency about 1200 pm because the hives, heat in my body did not go away. I was treated and placed on an iv cocktail and sent home with several medications. Diagnosed with urticaria allergic by DR. symptoms did not improve my skin was still red I felt hot, confused, dizzy and returned back to the same ER 01/09/2021 I was also involved in an unrelated motor vehicle accident earlier in the morning so got treated for that and continued my explanation and treatment of how my body is not doing well with the Covid 19 shot. I presented with tachycardia and was instructed to continue my medications prescribed from 1st visit on 1/7/2021. Today is 1/10/2021. My body still feels hot, fatigue, confusion and light headed. Remained out from work and continued bed rest.
42 2021-01-09 chest discomfort Woke the morning of Friday, January 8th, 2021 with a slight cough, heaviness to my chest, and extrem... Read more
Woke the morning of Friday, January 8th, 2021 with a slight cough, heaviness to my chest, and extreme fatigue. Had to use my inhaler twice, get rest, and plenty of hydration for 24 hours then felt fine.
42 2021-01-10 lightheadedness, chest pain Headache, chest pain, fatigue, feeling of near syncope
42 2021-01-10 chest discomfort Mild shortness of breath and chest tightness 10 minutes after the injection that resolved after 5 mi... Read more
Mild shortness of breath and chest tightness 10 minutes after the injection that resolved after 5 minutes without intervention. Remained in the observation room symptom-free for additional 30 minutes. At home, symptoms of shortness of breath and chest tightness returned and worsened. Throat felt tight, able to move air, however had trouble swallowing. Voice was raspy and increased coughing. From past experience with allergy shots, this was my cue to use epi pen. Within 5 minutes after using epi pen, all symptoms were resolved.
42 2021-01-11 chest pain 1/8 - Within 12 hrs had body, eye, and headache. Overall tired. Could not do normal daily things w... Read more
1/8 - Within 12 hrs had body, eye, and headache. Overall tired. Could not do normal daily things without feeling wiped out . 3 Advil did nothing- sat 1/9. Next day felt better.- sun 1/10. That evening low grade fever 99.6 and achy again., mostly eyes and head. Went to bed. Monday okay. But noticed right armpit a pit puffy.- same side as injection. Tuesday 1/12 woke up at 6:00am and had dull joint/bone pain bilaterally. Ranging from neck ache, to sternum/upper back, shoulders, triceps. Injection site still sore- slightly red off to the side. Did some stretches in bed and eventually got up. I am very in tune with my body- something is off. I never wake up feeling ?bad?. Fit, healthy and active normally. Almost like a bad nights sleep with a poor mattress but only affected my upper body. Took two Advil and hot shower- feel better but can tell something doesn?t feel right.
42 2021-01-11 fainting Developed syncope within a few minutes of receiving vaccine. Taken to the ED for treatment. given I... Read more
Developed syncope within a few minutes of receiving vaccine. Taken to the ED for treatment. given IV fluids, Benadryl, famotidine, methylprednisolone, IV fluid bolus and 02 along with reglan and Zofran. Total ED stay approximately 4 hours
42 2021-01-11 fainting Flu like symptoms, syncope, lymphadenopathy, nausea, fatigue, weakness.
42 2021-01-11 hypertension, fast heart rate TACHYCARDIA AND HYPERTENSION WITH ''TIGHTNESS OF THROAT", TREATED WITH IM BENADRYL, IMPROVED AND PAT... Read more
TACHYCARDIA AND HYPERTENSION WITH ''TIGHTNESS OF THROAT", TREATED WITH IM BENADRYL, IMPROVED AND PATIENT RELEASED SAME DAY
42 2021-01-11 loss of consciousness The day after the vaccine was given, 01/07/2021, I had a headache and nausea around 10:00am. I had ... Read more
The day after the vaccine was given, 01/07/2021, I had a headache and nausea around 10:00am. I had to leave work early. I fainted when I got home on Thursday. Felt very tired. So I rested the remainder of the day and that night. On Friday 01/08/2021, I felt very tired and had a temperature of 100.6. I slept most of the day. Friday night I fainted again around 8:00pm. Slept all night. Felt much better on Saturday. Felt normal from Sunday on.
42 2021-01-11 heart rate increased Vaccine given at 9;55 am and at 10;10 am patient c/o dizziness, nausea, fast heart rate. VS taken ... Read more
Vaccine given at 9;55 am and at 10;10 am patient c/o dizziness, nausea, fast heart rate. VS taken BP 116/78 HR 105, O2 sats 100. Pt was given water, raised her feet up and monitor her for additional 30 mins. 10:30am pt. states felt much better new VS taken BP 110/70 sats 100% HR 94, she left via walking.
42 2021-01-11 palpitations While patient was receiving her second dose of the Pfizer brand Covid-19 vaccination (at 14:50), she... Read more
While patient was receiving her second dose of the Pfizer brand Covid-19 vaccination (at 14:50), she mentioned to me that she had a sustained local reaction to her first dose. Her arm had a hard, red, hot spot for approximately a week. At this time I told her we would like her to stay under observation for 30 Min instead of the normal 15 min. At approximately 25 min post vaccination, the pt reported the following: "arm felt heavy, both arms did, but more so the affected arm, instant headache, sore neck, vision went fuzzy, breathing wasn't difficult but felt labored, throat felt like it was closing/congested, rash on the inside of the affected arm".   Pt stated that her heart felt like it was "pounding".   VS: 162/96, 99% RA, HR in the 70's.   Patient was administered 50ml IM diphenhydramine and monitored for 90 minutes in the clinic area. Dr. was consulted and also spoke with the pt, advising her to continue with OTC diphenhydramine once at home.   The symptoms resolved after approximately 40 minutes. By 17:00 the patient was deemed stable to go home with the instructions to go immediately to ED should any further Sx present. It was verified that she did not live alone and would have someone with her that could assist.   Pt was subsequently followed up with a phone call on the next day by RN who relayed that she was very tired, but no other complications.  
42 2021-01-11 blood pressure increased patient began to have headache (pressure back of head), some shortness of breath with an elevated bl... Read more
patient began to have headache (pressure back of head), some shortness of breath with an elevated blood pressure. Patient stayed for monitoring for 30 mins and symptoms aleviated
42 2021-01-12 heart rate increased, hypertension 10 minutes after the shot was given, I suddenly felt my heart was racing and a tingling sensation st... Read more
10 minutes after the shot was given, I suddenly felt my heart was racing and a tingling sensation started from my left arm and radiated to my whole body. The sensation was very intense it felt like my whole body was being paralyzed. I was fading out because of high heart rate. My heart rate was 160 and I heard someone said my blood pressure was high. I was transferred to the ER and given epinephrine, anti-histamine, steroids.
42 2021-01-12 chest discomfort About 20 min after my chest started feeling tight. 3 hours later my stomach started feeling queasy..... Read more
About 20 min after my chest started feeling tight. 3 hours later my stomach started feeling queasy...later that night I started with loose stools...The queasiness and loose stools lasted through the next day and than were gone. My muscles in my back, jaw, and arms seem to get tight and than release...almost like spasms....it feels like my jaw is trying to lock. ...This started the first night and is still continuing now.
42 2021-01-12 blood pressure increased Patient initially experienced tingling in left hand right after injection. This resolved but then sh... Read more
Patient initially experienced tingling in left hand right after injection. This resolved but then she began to have tingling in her lips. Then she had tingling at the tip of her tongue and then her neck began to feel stiff. Her blood pressure also rose to 145/72. Her baseline BP is usually 96/69. She was administered 02.ml epinephrine subcutaneously, Then when her lip tingling did not resolve, Benadryl 50mg IM injection was given. After 2 hours of observation, her symptoms resolved and she was released to go home. No ER visit was necessary.
42 2021-01-12 pallor wednesday-dyspnea on exertion(took tylenol worked shift as nurse) thursday morning-joint swelling an... Read more
wednesday-dyspnea on exertion(took tylenol worked shift as nurse) thursday morning-joint swelling and pain thursday night-more dyspnea, joint pain, general swelling, joint pain (took tylenol worked shift as nurse) friday-fatigue, joint swelling, general swelling, dyspnea blanching (took tylenol and ibuprofen worked shift as nurse) saturday-extreme fatigue, joint pain and swelling, general swelling, dyspnea sunday, facial swelling, petichiae on legs and back, joint, pain and swelling, fatigue requiring visit to hospital
42 2021-01-13 heart rate increased 1700 felt increase in HR (120), warm feeling, B/P 132/80 Upper chest and facial cheeks along with e... Read more
1700 felt increase in HR (120), warm feeling, B/P 132/80 Upper chest and facial cheeks along with ears flushed 1715 nausea, no vomiting, light headedness, mouth dry, tolerated apple jice and crackers 1830 felt normal
42 2021-01-13 chest discomfort Felt like a sticky film was in my throat and I could not swallow nor get any air in.; Felt like a st... Read more
Felt like a sticky film was in my throat and I could not swallow nor get any air in.; Felt like a sticky film was in my throat and I could not swallow nor get any air in.; Woke up from a deep sleep diaphoretic and unable to breathe; I felt weak and had tightness in my chest; I felt weak and had tightness in my chest; diaphoretic; This is a spontaneous report from a contactable nurse. A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number=Ek5730 and expiry date unknown, via an unspecified route of administration on the right arm on 30Dec2020 14:30 at a SINGLE DOSE for covid-19 immunisation. Medical history included herpes zoster from an unknown date and unknown if ongoing, drug hypersensitivity from an unknown date and unknown if ongoing. Concomitant medication included hctz (HCTZ) and valaciclovir hydrochloride (VALTREX). The patient previously took levaquin and experienced drug hypersensitivity, percocet [oxycodone hydrochloride;paracetamol] and experienced drug hypersensitivity and influenza vaccine. On 02Jan2021, the patient woke up from a deep sleep diaphoretic and unable to breathe. She felt like a sticky film was in my throat and I could not swallow nor get any air in. It took over an hour to clear my airway enough to feel like I was getting a good breath and I felt weak and had tightness in my chest for 2 days after also. The outcome of the events felt like a sticky film was in my throat, could not swallow and unable to breathe were recovering while other events were unknown.
42 2021-01-13 hypertension, hypertension Systemic: dizzy and bp high 149/95
42 2021-01-13 blood pressure increased The day of the vaccination blood pressure went up. Then on 01/13/2021 she developed some rash starti... Read more
The day of the vaccination blood pressure went up. Then on 01/13/2021 she developed some rash starting by earas, eyes and then all over body. Patient refers she also take Methotrexate for her medical conditions.
42 2021-01-13 lightheadedness acute onset nausea; diaphoresis; presyncope; left arm weakness with numbness; numbness and tingling ... Read more
acute onset nausea; diaphoresis; presyncope; left arm weakness with numbness; numbness and tingling of first 3 fingers in left hand (median nerve distribution); tingling of first 3 fingers in left hand (median nerve distribution).; significant cervical lymphadenopathy; painful neck; This is a spontaneous report from a contactable physician reporting for herself. A 42-year-old adult female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, Lot number: EJ1686, via an unspecified route of administration, in left arm, on 06Jan2021 at 9:52 am, at 42-years of age, at single dose for COVID-19 immunization. The patient was vaccinated in Hospital. Medical history included overweight and no known allergies. Concomitant medications included the second dose of HPV VLP vaccine rL1 4v (yeast) (GARDASIL) received in left arm on 18Dec2020 and ergocalciferol (Vitamin D). On 06Jan2021 by 10:05 the patient experienced acute onset nausea, diaphoresis, presyncope and concomitant left arm weakness/flaccid arm with numbness and tingling of first 3 fingers in left hand (median nerve distribution). The patient informed vaccine staff of symptoms and advised ongoing observation. Flaccid arm/weakness/numbness continued for more than 24 hours, although at the time of the report it was slowly improving. At the time of the report the patient further reported significant cervical lymphadenopathy and painful neck (specific onset date not provided - captured as Jan2021). The events were reported as non-serious. The reporter specified that the injection was not given anywhere near brachial plexus. At the time of the report the events "Left arm weakness" and "Left arm numbness" were resolving, the outcome of the events "Nausea", "Diaphoresis", "Presyncope", "Tingling of first 3 fingers in left hand", "Cervical lymphadenopathy" and "Painful neck" was unknown.
42 2021-01-13 chest discomfort chills; body ache; headache; fatigue; upper chest discomfort with deep breath; This is a spontaneous... Read more
chills; body ache; headache; fatigue; upper chest discomfort with deep breath; This is a spontaneous report from a contactable other health professional (patient herself). A 42-year-old female patient (non-pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL3246), via an unspecified route of administration on 02Jan2021 11:00 in left arm at single dose for covid-19 immunization. The patient medical history was not reported. Allergies to medications, food, or other products was no. Concomitant medication included escitalopram oxalate (LEXAPRO, 10 mg) and vitamins nos (MULTIVITAMIN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The most recent COVID-19 vaccine was administered in pharmacy or drug store. The patient experienced symptoms chills, body ache, mild headache, fatigue, and upper chest discomfort with deep breath on 06Jan2021. Patient never had a fever. Symptoms were resolved by the next day (07Jan2021). No treatment was received for the events. All events were reported as non-serious. No follow-up attempts are possible. No further information is expected.
42 2021-01-13 palpitations headache; injection site is itchy and swelled up; injection site is itchy and swelled up; But this o... Read more
headache; injection site is itchy and swelled up; injection site is itchy and swelled up; But this one turned red; can't lift her arm it's heavy and painful; can't lift her arm it's heavy and painful; shortness of breath; palpitation; Dizziness, lightheaded/ feeling dizzy; Uneasiness; hands are so cold; nauseous; This is spontaneous report from a contactable nurse reported for herself. This 42-year-old female patient (No pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via Intramuscular on Left arm on 29Dec2020 17:00 PM on left arm at single dose (Lot # EL1284) for COVID-19 immunisation. Medical history included None. No Allergies to medications, food, or other products. Concomitant medications included ascorbic acid, bioflavonoids nos, hesperidin, malpighia glabra, rosa canina, rutoside (VITAMIN C), collagen, colecalciferol (VITAMIN D), cynara cardunculus, malus spp. vinegar extract, taraxacum officinale (APPLE CIDER). No other vaccine in four weeks. The patient experienced Dizziness, lightheaded, palpitation, uneasyness, shortness of breath on 29Dec2020 17:15 pm. Then when the patient drove home, she felt so uneasy and hands are so cold, nauseous and feeling dizzy on 29Dec2020 17:15 pm. Felt the same way in the house for a good 2 hours after the vaccination. Drank water and didn't sleep right away. Tried to monitor herself. After that day the patient felt better but with bouts of headache and dizziness every now and then. The injection site was itchy and swelled up. But it went down if didn't scratch it. The patient didn't have allergies to any medications. But this one turned red. And the next day after the vaccination (30Dec2020) the patient can't lift her arm it's heavy and painful. Then pain went away. But now it was the itchiness in the site that bothered her. But the patient didn't scratch it. So it didn't swell up as much. Prior to vaccination, was the patient did not diagnose with COVID-19. Lab data on 07Jan2021 Nasal Swab post vaccination for Covid 19: result was pending. No treatments received for the events. Outcome of the events Dizziness, lightheaded/ feeling dizzy, palpitation, Uneasiness, shortness of breath, hands are so cold, nauseous was recovering. Outcome of the event pain in arm was recovered. Outcome of other events was unknown.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the dizziness, lightheaded, palpitation, shortness of breath and other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including chest x-ray, EKG and chemistry panel, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
42 2021-01-14 lightheadedness, hypotension 5 min after vaccine administration, developed 3 pre-syncopal episodes and low blood pressure. Conti... Read more
5 min after vaccine administration, developed 3 pre-syncopal episodes and low blood pressure. Continued with paresthesias in lips, mouth, tongue, finger, legs, and toes. 2-3 hours after administration developed lip, face and tongue swelling. Administered Zyrtec and tylenol. Symptoms improved but continued into next day. 18 hours after administering vaccine developed rigors, fever (Tmax 103), severe myalgias, fatigue, nausea, vomiting, diarrhea, abdominal cramping. These symptoms persisted for another 12 hours. Tylenol was given to assist fever and pain.
42 2021-01-14 lightheadedness, hypotension After 5 min following administration, developed low blood pressure and 3 pre-syncopal events. Conti... Read more
After 5 min following administration, developed low blood pressure and 3 pre-syncopal events. Continued with paresthesias in lips, tongue, mouth, fingers, legs, and toes. 2-3 hours after administration, developed lip swelling, facial swelling, and swelling of tongue. Zyrtec and tylenol were given. This improved but was still present the next day. At 18 hours following administration, developed rigors, fevers (Tmax 103), severe myalgias, nausea, vomiting, diarrhea, and abdominal pain. These persisted for another 18 hours.
42 2021-01-14 chest discomfort Chest tightness. On the inside , felt like I needed to exhale; administration date=07Jan2021, admini... Read more
Chest tightness. On the inside , felt like I needed to exhale; administration date=07Jan2021, administration time=02:00 PM, dose number=2/administration date=18Dec2020, administration time=11:00 AM, dose number=1; This is a spontaneous report from a contactable nurse (patient herself). A 42-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3246; expiry date: unknown) via an unspecified route of administration (left arm), on 07Jan2021 at 14:00 at a single dose, for COVID-19 immunization. Relevant medical history included allergies to penicillin. Concomitant medication included acyclovir (ACYCLOVIR). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL 0140; expiry date: unknown) in the right arm on 18Dec2020 at 11:00 AM, for COVID-19 immunization. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. On 08Jan2021, at 21:00, the patient experienced chest tightness. On the inside, she felt like she needed to exhale. The patient did not receive treatment for the event. Outcome of the event chest tightness was not recovered.
42 2021-01-14 palpitations Patient felt like heart was racing 15 minutes after injection. Resolved spontaneously after a couple... Read more
Patient felt like heart was racing 15 minutes after injection. Resolved spontaneously after a couple minutes. No interventions performed
42 2021-01-14 blood pressure increased Symptoms started next day with tiredness, low grade temp of 99 and over all not feeling well. Contin... Read more
Symptoms started next day with tiredness, low grade temp of 99 and over all not feeling well. Continued into Saturday. Sunday, Monday and most of Tuesday felt normal. Tuesday evening started to fell worse and Wednesday 1.13.21, 6 days after shot, headache, nauseous, very tired, could not go to work. Called Doctors office and spoke to two different nurses who advised these were normal reactions although maybe delayed. By end of day headache and nausea were gone but still felt unwell. 1.14.21 well enough to work, mostly normal. Took blood pressure and it was elevated by 20 points! BP is still elevated on 1.15.21.
42 2021-01-14 lightheadedness Vaso vagal response. No LOC. No additional medical treatment required.
42 2021-01-15 chest discomfort Headache, fever 101, severe body aches, joint pain, chills, sore throat, shakes, chest tightness, sh... Read more
Headache, fever 101, severe body aches, joint pain, chills, sore throat, shakes, chest tightness, shortness or breath, muscle stiffness all over and muscle weakness, nausea
42 2021-01-17 fast heart rate, chest pain 10:35a: COVID vaccine #1 Sitting in monitoring room. 11:05a: checked for symptoms and reports shor... Read more
10:35a: COVID vaccine #1 Sitting in monitoring room. 11:05a: checked for symptoms and reports shortness of breath and wheezing. Has history of asthma and has albuterol with her. 11:08a: O2 100% RA, HR 116 Took albuterol inhaler x2 puffs Ongoing shortness of breath. Reports sharp pain in her chest. Reports dizziness. 11:10am BP: 110/84, O2 99%, HR 113. No wheezes on exam Drank fluids and given snack. Reports difficulty swallowing. Sharp pain in chest is worsening. Shortness of breath worsening. Reports nausea. 11:18a: glucose 178. HR 112, O2 100%. Ongoing sharp pain in chest and worsening shortness of breath 11:20a: Given Benadryl 25mg and orange juice. 11:30a: Requests to go to ER ? 911 was called. Repeats albuterol inhaler 11:40a Reports shortness of breath worsening and closing sensation in her throat. Burning sensation in her mouth. Chest pains worsening and ongoing dizziness. Given epipen 0.3mg [due to shortness of breath, sensation of throat closing, nausea, dizziness, tachycardia] 11:43a: EMS arrive, assess and transport to ER
42 2021-01-17 pallor AFTER INJECTION PATIENT FELT WARM SENSATION IN HER TORSO. PATIENT ALSO STATED SHE HAD A HEADACHE, NA... Read more
AFTER INJECTION PATIENT FELT WARM SENSATION IN HER TORSO. PATIENT ALSO STATED SHE HAD A HEADACHE, NAUSEA AND BOIDY PAIN. PATIENT WAS PALE WHEN PLACED IN AMBULANCE AND GIVEN OXYGEN AND HAD HER FEET ELEVATED. PATIENT WAS IN AMBULANCE FOR ABOUT 25 MINUTES AND COLOR DID NOT COME BACK TO NORMAL EVEN AFTER THE OXYGEN ADMINISTRATION. THE PATIENT WAS ADVISED AND CONVINCED TO ALLOW THE AMBULANCE TO TRANSPORT HER TO HOSPITAL TO BE ASSESSED WHICH SHE AGREED TO. I CALLED THE PERSON ON 1/17/2021 @ 8:54 PM AND SHE STATED THAT SHE STILL FEELS A LITTLKE UNDER THE WEATHER BUT IT HAS GOTTEN BETTER
42 2021-01-17 pallor About 20 minutes after Dose 1 of vaccine administration, pt developed urticaria to neck. Denies SOB,... Read more
About 20 minutes after Dose 1 of vaccine administration, pt developed urticaria to neck. Denies SOB, resp difficulty, swelling of oral mucosa. Visual inspection of upper torso and extremities, no further urticaria noted. 5 minutes later, urticaria more pronounced. Pt sent to convenient care. pt presented with hives in the neck, slightly itchy. Pt denies respiratory distress, swollen lips, swollen tongue. Pt does have a history of asthma and has been on prednisone many times. Pt had urticarial rash with erythematous patches on anterior chest that are blanchable. No welts anywhere. No rashes anywhere else. Pt was given diphenhyramine 25 mg IM x 1 and rash/itchiness started to get better. Pt discharged home with a prescription for prednisone 40 mg PO QD x 5 days and instructions to take diphenhydramine Q6h PRN. Pt already on loratadine. Pt instructed to f/u with PCP.
42 2021-01-17 chest discomfort At approximately 30 hours after the second dose, had acute onset of mild-moderate chest tightness, d... Read more
At approximately 30 hours after the second dose, had acute onset of mild-moderate chest tightness, drop in peak flow (~20% decrease) and coughing. This was treated with a single dose of Albuterol 2.5mg/3mL nebulized with complete resolution. No further shortness of breath. (Concurrently, also had mild tiredness and muscle aches.)
42 2021-01-17 blood pressure increased Elevated BP with migraine headache. BP 160/104, HR 106. Reported- visited doctor and BP returned to... Read more
Elevated BP with migraine headache. BP 160/104, HR 106. Reported- visited doctor and BP returned to normal.
42 2021-01-17 palpitations Employee reported palpitations 5 minutes after vaccine was administered then began having rash on ch... Read more
Employee reported palpitations 5 minutes after vaccine was administered then began having rash on chest and tingling in lips and face. Benadryl 25mg and Epi-pen were administered. Symptoms got better and employee went home. Had to go back to Emergency Room for tingling all over and flushing to face.
42 2021-01-17 blood pressure increased Patient reports she stared experiencing hives 10 min after 2nd dose, was held in observation room fo... Read more
Patient reports she stared experiencing hives 10 min after 2nd dose, was held in observation room for high BP and was given 2 doses of Benadryl, was sent home after 1 hr, 2nd day reports severe HA which resolved same day with Aleve, today 1/18 reports still experiencing hives & continues to take PO Benadryl daily
42 2021-01-18 heart rate increased, chest discomfort Every time I stood up, my heart rate went up into the 120's and I felt an intense pressure in my che... Read more
Every time I stood up, my heart rate went up into the 120's and I felt an intense pressure in my chest. I felt like I couldn't breathe. All day that day I has also experienced feeling hot but I never got a fever. The chest pressure last for a few hours every time I tried to get up. I had a couple of minor episodes over the next 2 days where my heart rate went into the 120's and I felt slightly short of breath but no pressure.
42 2021-01-18 lightheadedness, heart rate increased, blood pressure increased Patient was administered 2nd vaccine on 1-8-21 by a nursing student. During 15 observation period, ... Read more
Patient was administered 2nd vaccine on 1-8-21 by a nursing student. During 15 observation period, arm began to feel cold at injection site area. At that point the patient realized the vaccine was given toward the back of upper left arm near the fatty tissue instead of toward the middle of the arm. Approximately 20 min after vaccine administration, patient became short of breath, dizzy, light headed, and throat felt a little swollen and almost passed out. A rapid response was called and the patient was seen by Occupational Health. The patient's BP and heart rate were elevated but normalized during observation in Occupational Health. At this time, the patient did not feel they needed to be seen in the emergency department. The patient was discharged home at this time. 12 hours after the shot, the patient began experiencing normal side effects from the vaccine. The nursing student was informed of administration at the incorrect site.
42 2021-01-18 blood pressure increased Uncontrolled elevated BP ranging 192/102 on multiple readings.
42 2021-01-19 palpitations Heart was racing and lightheadedness
42 2021-01-19 heart rate increased Immediate arm and neck soreness/12 hours later joint pain , Back pain, muscle aches, headache, rapid... Read more
Immediate arm and neck soreness/12 hours later joint pain , Back pain, muscle aches, headache, rapid heart rate, metallic taste in mouth. weakness, fatigue, Symptoms still current after 2 weeks post vaccine.
42 2021-01-19 hypertension Initial difficulty breathing and altered mental status, with hypertension 152/98 at 15 minutes (no o... Read more
Initial difficulty breathing and altered mental status, with hypertension 152/98 at 15 minutes (no other vitals available), gradually improving over about 30 minutes, followed by severe fatigue
42 2021-01-19 chest pain substernal chest pain and pain in axillary region of rib cage on both sides
42 2021-01-20 heart rate increased Joint tightness/tightness of her joints and muscles; Muscle tightness/tightness of her joints and mu... Read more
Joint tightness/tightness of her joints and muscles; Muscle tightness/tightness of her joints and muscles; Tiredness/felt tired; fast heartbeat; Difficulty breathing; Dizzy; Nausea; Joint pain; Muscle pain; she was not feeling well; swelling and tightness in her left arm; swelling and tightness in her left arm; Injection site redness/redness of her left arm and injection site swelling; Injection site swelling; This is a spontaneous report received from a contactable other healthcare professional (who is also the patient). A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248, expiry date unknown), via an unspecified route of administration in upper left arm, on 08Jan2021 09:25, at single dose, for COVID-19 immunization, in a public health department. There were no medical history and concomitant medications. The patient did not receive prior vaccinations within 4 weeks. The patient reported she received the COVID-19 Vaccine on Friday, clarified as 08Jan2021 at 9:25 in her left upper arm. She stated experiencing a little bit of side effects since receiving the COVID-19 Vaccine. Shortly after receiving the COVID-19 Vaccine, on 08Jan2021, she was not feeling well. She said she had swelling and tightness in her left arm that started approximately a half hour (30 mins) after receiving the COVID-19 Vaccine on 08Jan2021. She then experienced redness of her left arm and injection site swelling on 08Jan2021. On 10Jan2021 (at night), she felt tired, and had tightness of her joints and muscles. She also experienced a fast heartbeat, and difficulty breathing last night, 10Jan2021. She said her dizzy feeling, nausea, tiredness, and joint and muscle pain were persisting at the time of the report. She reported she thought she was feeling fine up until Sunday, 10Jan2021. She stated her new symptoms started in the late afternoon, and the symptoms have stayed into the morning of 11Jan2021. She reported having previously scheduled a doctor's appointment for 22Jan2021 and will speak with her doctor at that time if she continues to have symptoms. The patient declined treatment for the events. The outcome of the events are joint stiffness, muscle tightness, fatigue, dizziness, nausea, arthralgia and myalgia was not recovered; peripheral swelling, musculoskeletal stiffness, heart rate increased and dyspnea were recovering; vaccination site erythema and vaccination site swelling were recovered on an unspecified date; and malaise was unknown.
42 2021-01-20 fast heart rate Tachycardia/shortness of breath 160-180?s sustained 20 min
42 2021-01-21 heart rate increased Receiver second Pfizer shot on January 20 2021 and that night at 01:30 January 21,2021 I woke up wit... Read more
Receiver second Pfizer shot on January 20 2021 and that night at 01:30 January 21,2021 I woke up with a rapid heart rate extreme headache and a fever of 102 I had shortness of breath and was taken to hospital. The ER performed a work up and my main complaint was my heart was hurting really bad I felt like my left carotid artery was swollen or occluded
42 2021-01-22 fainting, chest pain Day 1. Fatigue. Sleepiness. Loss of appetite Day 2. Muscle aches. Headache. Chills. Loss of appetit... Read more
Day 1. Fatigue. Sleepiness. Loss of appetite Day 2. Muscle aches. Headache. Chills. Loss of appetite. Episode of severe abdominal pain, chest pain, right shoulder pain, shortness of breath, syncope, diaphoresis, vomiting Day 3. Fatigue. Headache. Chest pain.
42 2021-01-22 blood pressure increased, pallor While sitting in observation patient became dizzy, felt nauseated and became pale. EMS was called t... Read more
While sitting in observation patient became dizzy, felt nauseated and became pale. EMS was called to her side. Her BP was elevated and she remained pale & dizzy. She was taken to ED. No medications were administered.
42 2021-01-23 chest discomfort, fast heart rate, hypertension, chest pain Blurred vision, headache, disorientation, fatigue, chest pain, chest pressure, shortness of breath, ... Read more
Blurred vision, headache, disorientation, fatigue, chest pain, chest pressure, shortness of breath, severe muscle and joint pain, hypertension, tachycardia, severe skin sensitivity, abdominal epigastric pain and spasms, severe cough, dizziness, lightheadedness. Reaction symptoms were not all immediate and developed over next 3 days requiring evaluation and treatment in the ER. I required decadron injection to stop inflammatory response and was sent home on oral decadron. I am still experiencing symptoms but not as severe. I have to take my albuterol inhaler so I can breathe easier. My monocytes count was elevated.
42 2021-01-24 chest pain, heart rate increased, fast heart rate About 8 minutes into shot, I got rapid heartbeats, sudden fatigue, chest pain, shortness of breath, ... Read more
About 8 minutes into shot, I got rapid heartbeats, sudden fatigue, chest pain, shortness of breath, and itching. I was taken to the hospital where I received Benadryl and compazine in an IV for nausea and headache and to fight reaction. Released at 5pm. Next three days felt like I was having panic attacks, very jittery, tired, body aches, nauseated, and a headache. Felt extremely bad. Today first day about to focus and fill out paperwork. I had COVID 10/27/2020. Fought it for 32 days and was given colchicine for paracarditist.
42 2021-01-24 fainting Faint; Shaking; Febrile; Rigors; light-headed; This is a spontaneous report from a non-contactable c... Read more
Faint; Shaking; Febrile; Rigors; light-headed; This is a spontaneous report from a non-contactable consumer (patient). A 42-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number unknown), via an unspecified route of administration on Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had no known allergies to medications, food, or other products. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on Dec2020 for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and unknown if there is any other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and unknown if the patient had been tested for COVID-19 since the vaccination. On Jan2021, the patient experienced faint, shaking, febrile for around 36 hours, rigors, and light-headed. No treatment was received for the adverse events. Outcome of the events was recovered on Jan2021. The events were considered non-serious by the reporter. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
42 2021-01-24 loss of consciousness Felt miserable, collapsed, blacked out for unknown length of time, diarrhea, sweating, hot flashes.
42 2021-01-24 heart rate increased RAPID HEART RATE 160-180, NO INTERVENTION.
42 2021-01-24 chest discomfort Second round of vaccine at 7:20am. On Jan 6, 2021. By 4pm, I felt achy and low grade fever. By 6pm I... Read more
Second round of vaccine at 7:20am. On Jan 6, 2021. By 4pm, I felt achy and low grade fever. By 6pm I had temperature of. 101.8. Achy, body/joints, headache. About 11pm I had a temp of 102.8. All the same symptoms, slightly heavy chest with breathing but not problematic. Very tired and no energy.The symptoms 36 hrs. Medication to help reduce fever did not work. After 36 hours I felt better except I still had no energy, and I had a migraine that lasted approximately 5 days ( lasted through Sunday January 10, 2021) I am a white female with red hair.
42 2021-01-24 palpitations Shortness of breath, hot all over, diaphoresis, tightening of the throat, feeling of passing out, he... Read more
Shortness of breath, hot all over, diaphoresis, tightening of the throat, feeling of passing out, heart racing. Within 5 minutes of vaccine. Epinephrine auto injection and oxygen followed by steroid, Benadryl and omeprazole with oxygen in the ER.
42 2021-01-25 chest discomfort 1st 5 to 7 min dizziness, 10 to 15 min right tongue heaviness and left lower lip tingling, chest tig... Read more
1st 5 to 7 min dizziness, 10 to 15 min right tongue heaviness and left lower lip tingling, chest tightness. All mild symptoms. tongue and Lip Issues resolved in abt 1 hour and chest tightness in abt 2 hours.
42 2021-01-25 fast heart rate, chest pain Extreme fatigue, weakness, slept 36 hrs, stomach cramping, nausea, diarrhea, chills, muscle aches, h... Read more
Extreme fatigue, weakness, slept 36 hrs, stomach cramping, nausea, diarrhea, chills, muscle aches, headaches, chest pain, tachycardia up to 201, bp up to 210/101 with no cardiac history
42 2021-01-26 platelet count decreased After getting the second shot of Pzifer vaccine on Jan 14, 2021, I developed a drop in platelet coun... Read more
After getting the second shot of Pzifer vaccine on Jan 14, 2021, I developed a drop in platelet count. I have no pre existing conditions before taking the vaccine . Last year my platelet count was 166. After 1 week of taking the second shot of vaccine my platelet count dropped to 129. After 5 days later I had reexamined the cbc and the platelet dropped to 121. I believe it is a reaction to the vaccine.
42 2021-01-26 palpitations Heart issues, palpitations, shortness of breathe. Seeing physician. reported this on 1/27/2021.
42 2021-01-26 nosebleed Less than an hr after the vaccine I suffered a gushing bloody nose. About 10pm I started having at ... Read more
Less than an hr after the vaccine I suffered a gushing bloody nose. About 10pm I started having at gurgling, discomfort feeling in my stomach which had me in the restroom all night followed by fever and diarrhea. On 12/31 I was sent for a COVID test and results on 1/1 showed that I was positive resulting in me being out of work for a total of 3 weeks. And as of today I am still experience mild COVID like symptoms
42 2021-01-26 blood pressure increased, heart rate increased, palpitations heart started to race; tingling sensation from her left arm that radiated to all over her body to th... Read more
heart started to race; tingling sensation from her left arm that radiated to all over her body to the point where she felt paralyzed; tingling sensation from her left arm that radiated to all over her body to the point where she felt paralyzed; heart rate jumped to 160; heart rate jumped to 160 and blood pressure went up; choking sensation on her neck; This is a spontaneous report from a contactable healthcare professional. A 42-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL1284/expiration date), dose number 2 via an unspecified route of administration on 12Jan2021 at a single dose on the left arm for COVID-19 immunization. Medical history was not reported. The patient did not have COVID prior vaccination. The patient previously took nitroglycerin and experienced drug allergy. Historical vaccine included BNT162B2 (lot number EL0140, dose number 1) for immunization on 22Dec2020 after which the patient experienced mild headache. Concomitant medications were not reported. There were no other vaccines received within 4 weeks. The patient had no adverse reaction other than mild headache after the first dose, so she was very relaxed and she felt comfortable getting the 2nd dose. However, after 10 minutes after the second dose, her heart started to race and she started to feel a tingling sensation from her left arm that radiated to all over her body to the point where she felt paralyzed. Her heart rate jumped to 160 and her blood pressure went up. She couldn't even open her eyes nor speak a word. She was transported to the ER and was given steroids and anti-histamine. She refused to get an epinephrine shot at first, but she started to feel choking sensation on her neck so she asked for an epi shot. The patient had not been tested for COVID post-vaccination. The outcome of the events was recovering.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for reported events heart racing, tingling sensation, paralyzed, heart rate high, blood pressure increased and chocking sensation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
42 2021-01-27 chest pain Chills, fever, Severe muscle pain in arms, legs, back and eventually I had chest pain for about an h... Read more
Chills, fever, Severe muscle pain in arms, legs, back and eventually I had chest pain for about an hour
42 2021-01-27 fast heart rate, chest discomfort Fever of 38 C for 3 days. Been feverish since then. Generalized Myalgia and arthralgia that not impr... Read more
Fever of 38 C for 3 days. Been feverish since then. Generalized Myalgia and arthralgia that not improves with NSAID. Tachycardia, headache, insomnia, fatigue, chest pressure.
42 2021-01-27 palpitations after waiting the 15 minutes patient started feeling palpitations. Registered Nurse took her pulse a... Read more
after waiting the 15 minutes patient started feeling palpitations. Registered Nurse took her pulse and noticed it was 120. Pt stated she felt dizzy but nothing else. walked pt over to vehicle where her husband was parked. pt decided to be taken to ED in her own vehicle for further eval
42 2021-01-27 heart rate increased, chest discomfort chills; heart rate shot up to the 120's; chest pressure; felt like I couldn't breathe every time I s... Read more
chills; heart rate shot up to the 120's; chest pressure; felt like I couldn't breathe every time I stood up; This is a spontaneous report from a contactable nurse (patient). A 42-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899, expiration date: unknown), intramuscular on the right arm on 29Dec2020 at 09:30 at a single dose for COVID-19 immunization. Medical history included occasional premature ventricular contractions (PVCs) and high blood pressure. The patient had no known allergies, is not pregnant and had no COVID prior vaccination. Concomitant medications included vitamin C [Ascorbic Acid] (VITAMIN C [ASCORBIC ACID]), vitamin D3 (VITAMIN D3), bromelains (BROMELAIN), quercetin (QUERCETIN), zinc (ZINC), acetylcysteine (NAC [ACETYLCYSTEINE]) and Probiotic. The patient had no other vaccines in four weeks. On 06Jan2021 at 21:00, the patient experienced chills all day but no fever. Around 9pm, her heart rate shot up to the 120s and she had chest pressure and felt like she couldn't breathe every time she stood up. When she laid down, it was better. These lasted about 3 hours. She had some very mild shortness of breath twice after this on the 7th and 9th, but it was not nearly as bad as on the 6th. The patient did not take any medication when these happened. The patient tested for COVID post-vaccination (07Jan2021) through COVID-19 PCR (Nasal Swab) which resulted negative. The events resulted in doctor or other healthcare professional office/clinic visit. No treatment was administered for the events. The events resolved on an unknown date in Jan2021.
42 2021-01-27 palpitations palpitations; fatigue; stomach cramping; This is a spontaneous report from a contactable consumer (p... Read more
palpitations; fatigue; stomach cramping; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3249), via an unspecified route of administration in left arm on 11Jan2021 12:00 at single dose for COVID-19 immunization. Medical history included Congenital Heart Disease, Transposition of the Great Arteries, Mustard Procedure. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID tested post vaccination and did not have COVID prior vaccination. The patient had no known allergies. Concomitant medication included losartan, ethinylestradiol, norethisterone acetate (JUNEL), bifidobacterium lactis (PROBIOTIC), ergocalciferol (VIT D). The patient experienced palpitations, fatigue, stomach cramping on 05Jan2021 14:00 (as reported, pending clarification) with outcome of recovering. The events resulted in Doctor or other healthcare professional office/clinic visit. No treatment was received.
42 2021-01-28 lightheadedness, pallor Given 1st dose of Covid vaccine on 1/5/21 and 24 weeks pregnant with hx of hypotension with pregnanc... Read more
Given 1st dose of Covid vaccine on 1/5/21 and 24 weeks pregnant with hx of hypotension with pregnancy. Felt nauseous and lightheaded after about 15 minutes, near syncopal episode, pallor color, taken to ED for evaluation and discharged
42 2021-01-28 chest pain, chest discomfort Hot to cold, headache, fatigue, cough, chest pain, boughts of breathlessness this was day 2, day 3 h... Read more
Hot to cold, headache, fatigue, cough, chest pain, boughts of breathlessness this was day 2, day 3 headache, body ache, chest pain probably from coughing. Cough was deep and hard in the morning after waking through out the morning I would cough a couple more time by noon I'm not coughing but my chest is heavy.
42 2021-01-29 heart rate increased Elevated heart rate, dizziness, flushing, numbness in hands - twice, one and five hours after shot. ... Read more
Elevated heart rate, dizziness, flushing, numbness in hands - twice, one and five hours after shot. Passed by itself.
42 2021-01-29 palpitations Patient felt lightheaded after shot. She drank water and ate candy and felt slightly better. She got... Read more
Patient felt lightheaded after shot. She drank water and ate candy and felt slightly better. She got up to leave and then felt palpitations; VS: BP 122/81, HR 74, O2 sat 97% on RA Pulse regular She sat down and symptoms resolved. Patient then left to go home, and was instructed to seek help if she felt worse.
42 2021-01-30 blood pressure increased 12/26/20: rec?d 1st dose Pfizer Vaccine?shortly afterward, she noticed swelling to the affected area... Read more
12/26/20: rec?d 1st dose Pfizer Vaccine?shortly afterward, she noticed swelling to the affected area Jan. 2 & 3: didn?t sleep well Jan. 4: mental fatigued Jan. 7: fever 101.2F, shallow breathing, upper quadrant pain, rash on neck Jan. 8: rash on abdomen; right flank pain?spoke with her Endocrinologist who think reactions are auto-immune related Jan. 15: increased blood pressure?consulted a Cardiologist and was prescribed a medication Jan. 15: had labs drawn?IgG 69 Jan. 28: consulted with a Neurologist who think she may have acute encephalitis related to the vaccine and recommended not to get the 2nd dose
42 2021-02-03 pallor (This RN was not direct observer of initial incident. Initial events as reported by initial respondi... Read more
(This RN was not direct observer of initial incident. Initial events as reported by initial responding RNs). Pt had just received Pfizer vaccination and was seated in observation area. Was observed to be "not looking well" and approached by staff. Pt began to hyperventilate, exhibit repetitive jerking motions to upper body/"pseudo seizure-like activity", and reported feeling nauseated. Began to slide out of chair, x2 RNs assisted pt to floor. Pt then placed in wheelchair and taken to Triage tent A. Pt remained alert and oriented throughout duration of event. VS @0915- BP 128/77 HR 131 Sats 100% on RA. 0.3mg IM epinephrine given at 0919. VS @ 0920 HR 108 0938 O2 sats 87% on RA, applied 0.5L O2 via nonrebreather mask. Sats back up to 100% @ 0939. Pt remains alert, intermittently exhibits periods of jerking actions and hyperventilation between periods of calm. With staff assist, called husband who was en route. VS @ 0940- HR 101, Sats 100% on 0.5L via nonrebreather. 50mg IM Benadryl given at 0940. VS @ 0950 HR 109 sats 100% on RA. Husband, to bedside. Pt remains alert. 1007 EMS arrives for transport to Emergency Department
42 2021-02-04 haemoglobin decreased On Saturday, her arm was sore, having chills, fatigued as well. The symptoms kind of went away. On... Read more
On Saturday, her arm was sore, having chills, fatigued as well. The symptoms kind of went away. On Thursday night, 1/28/21 had burning sensation on her feet, like fire on her feet. Went to bed, the feeling went over her entire body. The sensation continued on her hands and her feet. She went to the ER on Saturday morning, early in the AM on 1/30/21, informed her hemoglobin was a little low. Said that it could be neuro, saw her doctor and informed that she had received the vaccination and he prescribed Gabapentin for the neuropathy. He did blood work and going to check what would trigger the neuropathy pain.
42 2021-02-05 blood pressure increased Patient self pre-medicated with diphenhydramine at 0730 due to reaction from Pfizer 1st COVID vaccin... Read more
Patient self pre-medicated with diphenhydramine at 0730 due to reaction from Pfizer 1st COVID vaccination. Today 2/5/2021, 2nd vaccination approximately 0800. Started to feel chills and numbness/tingling in left arm which was vaccination side. Then developed numbness/tingling in both legs below the knees. Placed on pulse oximeter and vitals monitored. Vital signs normal although initially blood pressure elevated but came back down. ~0830 Patient placed on gurney, covered with warm blankets and given oral medications: diphenhydramine 25mg, famotadine 20mg, acetaminophen 500mg. At 0930 patient taken to ED as symptoms were not resolving. Patient had difficulty transferring from gurney to wheelchair for transfer due to leg numbness.
42 2021-02-07 blood pressure increased blood pressure skyrocketed; body was really hot touch; Dizziness; Shortness of breath; Headache; Thi... Read more
blood pressure skyrocketed; body was really hot touch; Dizziness; Shortness of breath; Headache; This is a spontaneous report from a contactable consumer(patient). The 42-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at left arm on 22Jan2021 13:10 at single dose for COVID-19 immunization. Medical history included ongoing injury to right foot. Concomitant drug included Steroid from 21Jan2021 and ongoing for injury to right foot. There was no prior Vaccinations within 4 weeks. On 22Jan2021, the patient experienced blood pressure skyrocketed and body was really hot touch with outcome of recovering, dizziness and shortness of breath with outcome of recovered on 22Jan2021, headache with outcome of not recovered. Patient went to Emergency Room for all events on 22Jan2021. It was reported that Patient received the first dose of the Covid-19 vaccine today. Patient had a severe reaction and went to the Emergency Room. Her blood pressure shyrocketed. She experienced dizziness, her body was really hot. You could feel it to touch. She had a headache and shortness of breath. Then She was given Benadryl, Zofran and steroids at the Emergency Room, no physician office. She was released because she was going home and going to bed. Information about Lot/Batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
42 2021-02-08 heart rate increased anaphylactic reaction; not able to breathe or talk; Her throat was closing up; This is a spontaneous... Read more
anaphylactic reaction; not able to breathe or talk; Her throat was closing up; This is a spontaneous report from contactable pharmacists and an other hcp and a nurse. A 42-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EN5318) intramuscularly on 25Jan2021 15:15 in right deltoid at single dose for COVID-19 immunization. Medical history included hypertension. No known allergies. Concomitant medications included high blood pressure medication. Patient was not able to breathe or talk. Her throat was closing up. They had to use epinephrine to help her breath. It was reported as anaphylactic reaction. The vaccine was administered at 15:15, patient was interacting with HCPs who asked basic questions and at some point (15:17) patient was not responsive, patient was not able to breath and talk. All events started from 25Jan2021 15:17. Patient was administered Epipen (also reported as Benadryl and Epinephrine) and "she came back". Patient was taken to hospital. Patient refused to call an ambulance. She was taken to hospital. The patient was not seen in the Emergency Department. The patient was not admitted to an Intensive Care Unit. No other vaccine in four weeks. No covid prior vaccination. Unknown if covid tested post vaccination. The patient did not receive any recent vaccines for any other conditions prior to the event being reported. The patient has not received any other vaccines around the time of bnt162b2 vaccination. The patient underwent lab tests and procedures, which included heart rate with result of went up as soon as epipen was administered, O2 saturation and vitals with unknown results, all on 25Jan2021. The outcome of the events was recovering. Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the very close temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the anaphylactic reaction with throat closing up and being unable to breathe or talk. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
42 2021-02-09 palpitations I have been really brain fogged; weird like feeling in her legs and it hardly lasted for five minute... Read more
I have been really brain fogged; weird like feeling in her legs and it hardly lasted for five minutes but it came with weakness/ same sensation in my arms, in arm that I got shot in and it came with hand weakness; I had a weird like feeling in my legs and it hardly lasted for five minutes but it came with weakness and it felt like a short of energy or anxiety; I had a weird like feeling in my legs and it hardly lasted for five minutes but it came with weakness and it felt like a short of energy or anxiety; Lethargy; Very tired; My heart kind of feel like it is pounding out from the chest like off and on throughout the day; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, on 17Jan2021 as a single dose, for COVID-19 immunization, lot number: unknown. Medical history and concomitant medications were not provided. Patient got the vaccine on 17Jan2021 and she had been really brain fogged and on Tuesday and Wednesday she had a weird like feeling in her legs and it hardly lasted for five minutes but it came with weakness and it felt like a short of energy or anxiety and then Friday evening, patient had the same sensation in her arms, in arm that she got shot in and it lasted for about ten minutes and it came with hand weakness and then she had no muscle pain necessarily but lethargy, very tired and her heart kind of feel like it was pounding out from the chest like off and on throughout the day, events occurred on unknown date in Jan2021. Patient called the doctor and he said to wait but it is kind of there now, so she had an appointment on Wednesday. Outcome of the events was unknown. Information on the lot/batch number has been requested.
42 2021-02-09 blood pressure increased I have lightheaded; elevated blood pressure; elevated blood pressure; This is a spontaneous report f... Read more
I have lightheaded; elevated blood pressure; elevated blood pressure; This is a spontaneous report from a Pfizer sponsored program. A 42-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL1283), intramuscular on 21Jan2021 08:00 at single dose on left arm for COVID-19 immunisation. Medical history included blood pressure elevated. Concomitant medications were none. When she took the first dose of the vaccine on Thursday 21Jan2021, about 2 minutes after receiving the injection she got really light-headed. They wanted her to be assessed by an EMT and when they assessed her, she had an elevated blood pressure. Last time her blood pressure was taken it was elevated and she had not had it checked since then. She was asking if it was safe to get the second dose. Patient declined any medical treatment, she was told to eat food and drink water. Outcome of lightheadedness was resolved on 21Jan2021. Outcome of blood pressure elevated was unknown.
42 2021-02-09 chest discomfort, palpitations shortness of breath; Several episodes of racing heart; chest pressure; fatigue; This is a spontaneou... Read more
shortness of breath; Several episodes of racing heart; chest pressure; fatigue; This is a spontaneous report from a contactable nurse (patient). A 42-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at arm right on 04Jan2021 at 15:30 at single dose for COVID-19 immunization. The patient medical history included allergies: shellfish from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On 04Jan2021 at 15:45, the patient experienced several episodes of racing heart, shortness of breath, chest pressure and fatigue. The events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included SARS-COV-2 test: negative on 11Jan2021. Therapeutic measures were taken as a result of the events and included treatment with albuterol. The patient outcome of the event was recovering. The information on the batch number has been requested.
42 2021-02-14 haemoglobin decreased developed diffuse tender adenopathy, weakness and fevers. Admitted with severe neutropenia - ANC 0.
42 2021-02-15 blood glucose increased Diabetic ketoacidosis without coma associated with type 2 diabetes mellitus (CMS/HCC) (2/15/2021) PO... Read more
Diabetic ketoacidosis without coma associated with type 2 diabetes mellitus (CMS/HCC) (2/15/2021) POA: Yes Active Problems: Uncontrolled type 2 diabetes mellitus with hyperglycemia, with long-term current use of insulin (CMS/HCC) (5/6/2016) POA: Not Applicable Lactic acidosis (2/15/2021) POA: Yes Vaccination reaction - suspected (2/15/2021) POA: Yes Hyponatremia (2/15/2021) POA: Yes Was admitted to the ICU for further treatment
42 2021-02-15 cerebrovascular accident Vaccine given 1-6-21, patient had a stroke left occluded carotid with dissection 1-11-21, no risk fa... Read more
Vaccine given 1-6-21, patient had a stroke left occluded carotid with dissection 1-11-21, no risk factors. 1-20-21 had second stroke, hospitalized for both episodes without residual symptoms.
42 2021-02-18 palpitations could not lift arm/move body; her tongue started to be tingly; fuzzy feeling; tongue swollen a bit; ... Read more
could not lift arm/move body; her tongue started to be tingly; fuzzy feeling; tongue swollen a bit; hives; hard to swallow; weird taste in mouth; a high grade fever over 103, went down on 03Feb2021 to 102, 101, 99, then 98.6; chills uncontrollably; heart racing a bit; joint-muscle pain; headache; dizziness; swollen lymphnodes; red rash on chest/arms/stomach with some hives; This is a spontaneous report from a contactable consumer reporting for herself. This 42-year-old non-pregnant female patient received the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EN9581) on 02Feb2021 at 10:30, in left arm, for COVID-19 immunisation. The first BNT162B2 vaccine dose was administered on 12Jan2021 at 13:30, lot number EL3246, in left arm, for COVID-19 immunisation. Medical history included heart murmur, acute sinusitis, allergies to acetaminophen/oxycodone (PERCOCET), cephalexin (KEFLEX), codeine, trees, pollen, grass, mold, cats, some dogs. The patient had no COVID prior to vaccination and COVID was not tested after vaccination. Concomitant medications were not reported. The patient received the second vaccine dose on 02Feb2021 at the hospital and was monitored for 30 minutes. Within that time her tongue started to be tingly, she experienced fuzzy feeling, tongue swollen a bit with hives, hard to swallow, weird taste in mouth. The nurse on staff walked her to the ED, she was admitted and treated for allergic reaction to the vaccine and received prednisone for 5 days and diphenhydramine (BENADRYL). Epipen if needed. Later that night, on 02Feb2021, the patient had a high grade fever over 103, chills uncontrollably, heart racing a bit, could not lift arm/move body, joint-muscle pain, headache, dizziness, swollen lymphnodes, hard to swallow, every side effect on sheet just really bad. Her fever eventually went down on 03Feb2021 to 102, 101, 99, then 98.6. She still had all other symptoms not as severe, later that night she had a bit of a red rash on chest/arms/stomach with some hives, swallowing was still a bit hard. She continued to take BENADRYL and steroid. 06Feb2021 was her last day of steroid. As of 06Feb2021 she was feeling a bit better with no fever, swallowing a bit hard but other symptoms were less. The events resulted in Emergency room/department or urgent care. Fever resolved on an unspecified date in Feb2021. The other events were resolving.
42 2021-02-21 blood pressure increased, hypertension Developed acute pericarditis on 2/14/2021. Completely healthy 42 yr old with no recent illnesses oth... Read more
Developed acute pericarditis on 2/14/2021. Completely healthy 42 yr old with no recent illnesses other then the vaccine. Developed myalgia, severe headache, and slightly elevated blood pressures 24 hours post second vaccine. Then 4 weeks later acute pericarditis.
42 2021-02-21 palpitations Palpaltations and dizziness
42 2021-02-21 chest pain, fibrin d dimer increased, heart attack Two days after the 2nd injection I started to have chest pain and not feel right. I went to the Stat... Read more
Two days after the 2nd injection I started to have chest pain and not feel right. I went to the Station where I volunteer. I did and EKG which showed Anterior Infarct. I went to the ER. They gave me 4 baby aspirin to take and some blood work. I was told the blood work showed elevated levels consistent with a blood clot as well. I had a CT scan to rule out a clot in my heart or lungs. Which it was negative. I was released and told to see a cardiologist in the next few days. I saw the cardiologist two days later who said I ended up with Pericarditis and that it should resolve on its own. I was feeling better until two days ago when I developed chest pain again. I again went to my fire station I volunteer for and did an EKG which showed Anterior Infarct. I am currently waiting for treatment from my cardiologist.
42 2021-02-22 fainting I woke up at 4:30am to shower. Once in the shower I got lightheaded, yelled for my husband, and as... Read more
I woke up at 4:30am to shower. Once in the shower I got lightheaded, yelled for my husband, and as he was getting there I fainted in the shower. I came to, rested a second but when he helped me up I fainted a second time. Laid in bed for several hours. Took blood pressure/heart rate around noon and heart rate was 115.
42 2021-02-22 heart rate irregular, blood pressure increased, heart rate increased Per patient report, 7 mins after vaccine she felt a head rush and felt faint. had a rash on chest, ... Read more
Per patient report, 7 mins after vaccine she felt a head rush and felt faint. had a rash on chest, increased HR and BP. Given Benadryl, was monitored and released. She felt normal from 2/15 to 2/18. Then on 2/19 she felt dizzy, tongue felt fuzzy, heart rate erratic. Came to the ED. Had normal labs. Vitals normalized. Went home. Thereafter from 2/19 to 2/23, felt dizzy, had erratic heart rate, was light headed and was having a hard time focusing. Came back to the ED on 2/23 and had a HR of 135 and BP of 177/108. Got IV fluids and vistaril. Her HR improved to 119 and her BP improved to 161/98.
42 2021-02-23 chest pain per patient she experienced nausea and pain after 1st dose received on 1/14/2021 patient states that... Read more
per patient she experienced nausea and pain after 1st dose received on 1/14/2021 patient states that after her second dose she experienced facial swelling, hives, chest pain , joint pain and feels tingling in her body
42 2021-02-24 chest discomfort 10 minutes after vaccination she developed mid-sternal chest tightness. No other allergic symptoms ... Read more
10 minutes after vaccination she developed mid-sternal chest tightness. No other allergic symptoms or SOB
42 2021-02-24 chest discomfort, blood pressure increased complaining of mild tightness of chest immediately following vaccination. Pt stated that tightness ... Read more
complaining of mild tightness of chest immediately following vaccination. Pt stated that tightness not uncommon with history of asthma and anxiety. Denied : any itching or allergy related complaints, any respiratory difficulty.
42 2021-02-24 chest pain, hypertension, fast heart rate tachycardia up to 201; up to BP 210/101; chest pain; Extreme weakness; slept 36hrs; nausea; no appet... Read more
tachycardia up to 201; up to BP 210/101; chest pain; Extreme weakness; slept 36hrs; nausea; no appetite; stomach cramping; headache; site soreness; dizziness; full body aches; chills; diarrhea; This is a spontaneous report from a non-contactable nurse who reported for herself, a 42-year-old female patient who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date unknown), via an unspecified route of administration on 21Jan2021, at the age of 42 years, at a single dose for COVID-19 immunization. Medical history included depression. Patient had no cardiac history. Patient had no COVID prior vaccination, and was not COVID tested post vaccination. The patient was not pregnant, and not pregnant at time of vaccination. Concomitant medication included celecoxib (CELEXA). On 22Jan2021, the patient experienced extreme weakness, slept 36hrs, tachycardia up to 201, up to BP 210/101, nausea, no appetite, stomach cramping, headache, site soreness, dizziness, chest pain, full body aches, chills, and diarrhea. No treatment was received for the events. The outcome of the events was recovering. No follow-up attempts are possible; Information about lot/batch number cannot be obtained.; Sender's Comments: The reported events including serious events hypertension, tachycardia, and chest pain were likely related to due to plausible temporal relationship. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
42 2021-02-25 chest discomfort 1st vaccine 1/22/21; 2nd vaccine 2/12/21; developed cough and chest tightness onset 2/25/21 and seen... Read more
1st vaccine 1/22/21; 2nd vaccine 2/12/21; developed cough and chest tightness onset 2/25/21 and seen at ICC same day; was COVID tested at ICC negative
42 2021-02-25 palpitations, chest discomfort Complained of chest tightness, flushed and palpitations, self resolved
42 2021-02-25 chest discomfort felt like I might pass out /dizzy; brain fog/hard time thinking; tightness of chest and throat; diff... Read more
felt like I might pass out /dizzy; brain fog/hard time thinking; tightness of chest and throat; difficulty swallowing; hard time thinking and talking normal; hard time thinking and talking normal; This is a spontaneous report from a contactable consumer (patient) A 42-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: en9815) on 11Feb2021 at 15:45 at single dose via an unspecified route of administration on right arm for COVID-19 immunization. Relevant medical history included congenital adrenal hyperplasia and slight lactose intolerance. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), prednisone and naphazoline hydrochloride (EYE DROPS [NAPHAZOLINE HYDROCHLORIDE]). On 11Feb2021 patient experienced dizzy, felt like she was to pass out, brain fog/hard time thinking and talking normal, tightness of chest and throat, difficulty swallowing. Events resulted in visit to emergency room. The latter 2 events continued to get worse so they gave the patient an epinephrine injection (reported as EPI shot). Benadryl IV was also administered. At the time of the reporting the patient was recovering from reported events.
42 2021-02-26 chest discomfort Throat itching, hoarse voice, nasal stuffiness, facial swelling (subjective), chest tightness Treatm... Read more
Throat itching, hoarse voice, nasal stuffiness, facial swelling (subjective), chest tightness Treatment - self treated with Benadryl (75mg), Zyrtec 10mg. Mild improvement 2 hours later, s/s not completely resolved at time of submission
42 2021-02-26 palpitations, hypertension extreme brain fog 8 days post vaccine - had it a little after shot for day and a half came back very... Read more
extreme brain fog 8 days post vaccine - had it a little after shot for day and a half came back very strong have had it all week intermittently. Shaky, racing heart, high BP all intermittent, gastrointestinal upset, headache, feeling run down, trouble breathing but lungs fine Disruptive to working, thinking daily life feel very weird on and off
42 2021-02-27 heart rate increased 9 hours after vaccine: Unable to lift arm more than 30 degrees up. 12 hours after vaccine: fatigue... Read more
9 hours after vaccine: Unable to lift arm more than 30 degrees up. 12 hours after vaccine: fatigue 15 hours after vaccine: fever 100.3-100.6. severe body aches. chills. elevated heart rate (100bpm), extreme fatigue. arm pain. unable to sleep 24 hours after vaccine: body aches, fatigue, skin did not want anything on it. general feeling unwell 36 hours after vaccine: fatigue 48 hours after vaccine: no symtoms
42 2021-02-28 nosebleed Bloody Nose, Headache, Body aches, Chills, Back Pain
42 2021-02-28 palpitations, chest discomfort, heart rate increased Within 5 minutes of getting the vaccine, felt HR going up. Walked straight for the door as she thou... Read more
Within 5 minutes of getting the vaccine, felt HR going up. Walked straight for the door as she thought fresh air might help. Felt shaky and cold sweats. Was very itchy. No visible rash. Felt a lump in her throat and tightness in her chest. Paramedics sat with her outside. Dizzy and confused and had to sit for an hour before feeling comfortable driving home. Then slept for the entire day. Felt heart palpitations throughout the day. HR was up to 128 at home. 2 days later started to feel better. Felt normal 4 days later.
42 2021-03-02 blood glucose increased I experienced sharp pain laterally through my deltoid muscle; ached/painful/ douloureux; Higher than... Read more
I experienced sharp pain laterally through my deltoid muscle; ached/painful/ douloureux; Higher than normal blood sugar; This is a spontaneous report from a contactable consumer (patient herself). A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not provided), via an unspecified route of administration in left arm on 27Jan2021 14:00 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. She had no allergies to medications, food, or other products. She was not pregnant. She did not receive any other vaccines within 4 weeks prior to the COVID vaccine or any other medications within 2 weeks of vaccination. The patient stated "I experienced sharp pain laterally through my deltoid muscle, ached/painful, and higher than normal blood sugar" on 27Jan2021 14:30. The events were reported as non-serious and no treatment was received. The outcome of the events was recovering. The patient had not been tested for COVID-19 since the vaccination. Information on the lot/batch number has been requested.
42 2021-03-04 heart rate increased chills; increased heart rate; poor sleep; fatigued; This is a spontaneous report from a contactable ... Read more
chills; increased heart rate; poor sleep; fatigued; This is a spontaneous report from a contactable consumer. A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL3247), via an unspecified route of administration in the right arm on 25Jan2021, at 12:15 as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 26Jan2021, at 12:15 the patient experienced chills, increased heart rate, poor sleep, and fatigued, which were non-serious. The patient underwent lab tests and procedures which included heart rate: increased on 26Jan2021. Details were as follows: hours after injection (just after midnight), the patient had chills, increased heart rate and poor sleep; next day she was fatigued and side effects subsided 24 hours after onset (midnight). The outcome of chills, increased heart rate, poor sleep, and fatigued was recovered in Jan2021, with no treatment No follow-up attempts are possible. No further information is expected.
42 2021-03-14 pallor, hypotension unexplained bruising; hypotension; pale face; diarrhea; facial numbness; nausea; general weakness/Lo... Read more
unexplained bruising; hypotension; pale face; diarrhea; facial numbness; nausea; general weakness/Low energy; dizzy; mild headache/severe headache; Sore arm; tired/Fatigue; This is a spontaneous report from a non-contactable Pharmacist reporting for herself. A 42-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3247), via an unspecified route of administration at right arm on 29Jan2021 13:45 at single dose for covid-19 immunisation. The COVID-19 vaccine was administered at Hospital. The patient's medical history included allergies to Sulfa, PCN, Ceph. Concomitant medications included calcium, colecalciferol (VITAMIN D) and Multivitamin. Patient was not pregnant. On 29Jan2021 07:00 PM: Sore arm, tired at night, 30Jan2021: Sore arm, fatigue, mild headache, 31Jan2021: Fatigue, severe headache, hypotension, pale face, diarrhea, facial numbness, nausea, general weakness, dizzy, 01Feb2021: Fatigue, severe headache, unexplained bruising, facial numbness, nausea, general weakness, dizzy. Employee Health sent patient for COVID testing at 13:20 (result: Negative). 02Feb2021: Fatigue, severe headache, facial numbness, nausea, general weakness, dizzy. 03Feb2021- 12Feb2021: Fatigue, severe headache, facial numbness, nausea, general weakness, dizzy. 11Jan2021: Fatigue, facial numbness. 12Feb2021: Fatigue, severe headache, facial numbness, general weakness. 23Feb2021 - Present: Low energy, intermittent mild-medium headaches. Adverse events resulted in: Doctor or other healthcare professional office/clinic visit, Disability or permanent damage. Therapeutic measures were taken as a result of sore arm and headache included Pain relievers. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was not recovered.; Sender's Comments: Considering temporal association and lacking of alternative explanation, a possible contributory role of BNT162B2 to all reported events cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
42 2021-03-15 pulmonary embolism n/v, chills, SOB, pulmonary embolism, pericardial effusion
42 2021-03-19 pulmonary embolism, deep vein blood clot Patient had calf swelling and then more after Covid Vaccine. Patient then had SOB. Patients primary ... Read more
Patient had calf swelling and then more after Covid Vaccine. Patient then had SOB. Patients primary obtained dopplers and CT chest, which showed DVT's and PE. Patient had shoulder surgery 3 months ago, is more sedentary than had been.
42 2021-03-21 cardiac arrest Miscarriage; Heart stopped on pregnancy; This is a spontaneous report from a contactable consumer (p... Read more
Miscarriage; Heart stopped on pregnancy; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration in the left arm on 26Feb2021 06:00 PM at a single dose for COVID-19 immunisation. The patient's medical history was not reported. The patient had no known allergies. The patient was 8 weeks pregnant at the onset of the event. Last menstrual date was on 01Jan2021. There were no concomitant medications in two weeks and no other vaccine in four weeks. The patient previously received her first dose of BNT162B2 on an unspecified date at 06:00 PM in the left arm for COVID-19 immunisation. The patient had not been diagnosed with COVID prior to vaccination. The patient experienced miscarriage and heart stopped on pregnancy on 02Mar2021 03:00 PM. Treatment was unknown. Event resulted in doctor or other healthcare professional office/clinic visit. The patient was due to deliver on an unknown date. The patient underwent Covid PCR test post vaccination on 04Mar2021, pending results. Outcome of the events was unknown. Information on lot/ batch has been requested.
42 2021-03-22 pulmonary embolism Pulmonary Emboli, shortness of breath
42 2021-03-29 fainting extreme pain in left side of neck with difficulty moving; fainted; dizziness; Extreme pain in left s... Read more
extreme pain in left side of neck with difficulty moving; fainted; dizziness; Extreme pain in left side of neck with difficulty moving; gout-like reaction in feet; arm pain; fatigue; weakness; body aches; left hand knuckles swelled turned red stiff and painful; left hand knuckles swelled turned red stiff and painful; left hand knuckles swelled turned red stiff and painful; headache; vision disturbances; shakiness; This is a spontaneous report from a contactable other health care professional (patient). A 42-year-old female patient (non-pregnant) received first dose BNT162B2 (Solution for injection, COVID 19, Pfizer, lot number: EN6198) via Intramuscular in Left arm on 04Mar2021 at 10: 45 at single dose for COVID-19 immunisation. Patient medical history included Gluten allergy. Concomitant medications included Phentermine, hydrochlorothiazide, ibuprofen. On 04Mar2021 at 16:00, patient had extreme pain in left side of neck with difficulty moving, gout-like reaction in feet, arm pain, fatigue, weakness, body aches, left hand knuckles swelled turned red stiff and painful, fainted, headache, vision disturbances, shakiness, dizziness. Adverse events was not resulted in Emergency room/department or urgent care. treatment was not given. No covid prior vaccination and no covid tested post vaccination. Outcome of events were not recovered.; Sender's Comments: Based on temporal assosciation, the causal relationship between BNT162B2 and the serious event, syncope cannot be completely ruled out.The impact of this report on benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events.
42 2021-04-01 hypertension, chest discomfort Ten days after the vaccine was administered I woke up feeling like something was wrong. I just didn?... Read more
Ten days after the vaccine was administered I woke up feeling like something was wrong. I just didn?t feel right. I tried to lay down to see if I could feel better but this did not help. Even while in a relaxed state my blood pressure was up to 170/97 and heart rate of 220. I was very dizzy and felt like fainting but did not lose consciousness. I had a terrible pressure in my chest, in the left side of my neck and along the inside of my left arm. Also notable my vision was blurred. Called 911 ambulance took me to the Hospital ER and the ekg they performed was abnormal and also notable when they drew my blood my sodium level was below the normal threshold. I had taken 3 nitroglycerin tablets and my symptoms subsided enough for them to let me go home. Since coming home my bp has remained elevated much higher than normal at around 135/85. I continue to feel not quite normal and have the pressure in my left side of neck, chest and left arm. I feel very certain this is all due to the covid vaccine I received.
42 2021-04-02 pulmonary embolism, blood clot, heart rate increased 10 days after my first shot my feet were swollen and I didn't feel well by 18 days after it was not... Read more
10 days after my first shot my feet were swollen and I didn't feel well by 18 days after it was not getting better. I got my 2nd shot on day 21 and the day after I got an alert on my Watch regarding resting heart rate exceeding 125bpm and have been inactive for 10mins, so my husband call the doctor's office to make an appointment. They said we could go to the appointment or hospital, so we went to the hospital.
42 2021-04-02 fainting, fast heart rate, loss of consciousness like blurry vision and then she lost her senses/loss of consciousness (fainting)/passed out; like bl... Read more
like blurry vision and then she lost her senses/loss of consciousness (fainting)/passed out; like blurry vision and then she lost her senses/loss of consciousness (fainting); tachycardia; mental confusion; loss of sphincter control (urinary incontinence)/pissed on herself; diarrhea; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered on arm left on 15Mar2021 13:15 (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunization at the pharmacy. Medical history was not reported. There were no concomitant medications. The patient was not pregnant (including at the time of vaccination). On 16Mar2021 13:15, she came around to feeling really something bad in her body. She described this as she had loss of consciousness (fainting) which started to feel like blurry vision and then she lost her senses. She then passed out for 5-8 minutes and she had loss of sphincter control (urinary incontinence) as she pissed on herself. She also had tachycardia and mental confusion by that time. They called an ambulance and she was brought to the emergency or urgency department/room. The events [loss of consciousness (fainting), loss of sphincter control (urinary incontinence), tachycardia and mental confusion] were considered as serious (medically significant). She also had several diarrhea (noted in 2021) episodes during one week. She had no COVID prior vaccination and not tested post vaccination. She would like to know if the reaction that she had with first dose vaccination was normal as she was afraid of the second one. The patient did not receive any treatment for the events of loss of consciousness (fainting), loss of sphincter control (urinary incontinence), tachycardia and mental confusion. Outcome of the event of diarrhea was unknown while recovering for the remaining events. Information on the lot/ batch number has been requested.
42 2021-04-06 hypertension, blood pressure increased 3/11/2021 vaccination Home BP, 3/14 was elevated 3/15 I called the midwives and they told me to come... Read more
3/11/2021 vaccination Home BP, 3/14 was elevated 3/15 I called the midwives and they told me to come in for monitoring. I had got in range of gestation hypertension and that they should induce me. I was induced on 3/15. This was my second pregnancy, EDD was 3/16, birth weight was 6lbs 9oz. *Post partem; high blood pressure. Magnesium treatment on 3/25
42 2021-04-09 fainting fainting; nauseous; I hit my head and chin on the dresser; I hit my head and chin on the dresser; I ... Read more
fainting; nauseous; I hit my head and chin on the dresser; I hit my head and chin on the dresser; I hit my head and chin on the dresser/seven stitches in my chin; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot ER8727) via an unspecified route of administration, administered in left arm on 25Mar2021 09:00 as single dose for COVID-19 immunization. The patient had no medical history. The patient was not pregnant and no known allergies to medications, food, or other products. The patient was not diagnosed with COVID-19 prior to vaccination and since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included hair vitamins, and tru metabolism in which the patient received within 2 weeks of vaccination. The patient received first dose of bnt162b2 for Covid-19 immunization on 04Mar2021, 09:30. On 26Mar2021, the patient reported that she went to use the restroom around 0300 am as she was feeling nauseous. The next thing she remembered was being woken up on the floor of her bedroom by her husband. As a result of fainting, she hit my head and chin on the dresser. This resulted in needing seven stitches in her chin. The events resulted in emergency room/department or urgent care and therapy included stitches, x-rays, EKG and urine test on an unspecified date with unknown results. Outcome of events was recovering.
42 2021-04-10 loss of consciousness Blackout; Sleeping a lot; This is a spontaneous report from a contactable consumer (patient). A 42-y... Read more
Blackout; Sleeping a lot; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Mar2021 (Batch/Lot Number: EN6204) at the age of 42-years-old as single dose for covid-19 immunisation. Medical history included seizure from 1994 to an unknown date (it is been happening since the patient was a teenager), epileptic from an unknown date and unknown if ongoing. Concomitant medication included levetiracetam taken for seizure from an unspecified start date and ongoing. The patient reported that she had like blackout from, assuming the vaccine the next day on 23Mar2021. It was kind of later in the day and then next day, 23Mar2021, she was just having kind of had a blackout and she was sleeping a lot and may have had a seizure, she was not really sure as she was sleeping a lot and may had a seizure; she was not sure and she was epileptic. The patient was grateful that she got the vaccine. The patient underwent lab test and procedures which included blood test: unknown on an unspecified date. The patient was recovering from the events. Information on the lot/batch number has been requested
42 2021-04-12 chest pain Patient received 1st dose of Pfizer COVID vaccine on 4/1/21. Patient developed shortness of breath, ... Read more
Patient received 1st dose of Pfizer COVID vaccine on 4/1/21. Patient developed shortness of breath, chest pain, cough, headache, body aches, and low grade fevers shortly after vaccination. She was tested for COVID on ~4/2/21 and on 4/11/21, and both tests came back positive. Patient presented to the ER on 4/11/21 and was admitted for COVID treatment.
42 2021-04-12 blood clot Three days after receiving the vaccine, I developed a blood clot in the lining of my stomach.; This ... Read more
Three days after receiving the vaccine, I developed a blood clot in the lining of my stomach.; This is a spontaneous report from a contactable consumer. A 42-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/Lot Number: EN6201), dose 1 via an unspecified route of administration, administered in Arm Left on 15Mar2021 11:30 as SINGLE DOSE for covid-19 immunization. The patient medical history was not reported. Concomitant medication(s) included ethinylestradiol, norgestimate (SPRINTEC) taken for an unspecified indication, on an unspecified date. On 18Mar2021 05:30 the patient experienced three days after receiving the vaccine, developed a blood clot in the lining of her stomach (thrombosis). The patient was hospitalized for three days after receiving the vaccine, developed a blood clot in the lining of her stomach for 3 days. Therapeutic measures with blood thinners were taken as a result of three days after receiving the vaccine, developed a blood clot in the lining of her stomach. The outcome of the event was recovered. Information on Lot/Batch number was available. Additional information has been requested.
42 2021-04-13 loss of consciousness, cerebrovascular accident I was admitted to ER with stroke and right arm weakness. While I was in the ER, I also developed ... Read more
I was admitted to ER with stroke and right arm weakness. While I was in the ER, I also developed unconsciously seizure. The diagnosis are Cerebral Venous Thrombosis (CVT, multiple clots) and Cerebral Venous Sinus Thrombosis (CVST), Focal motor seizure and Cerebral Edema.
42 2021-04-14 pulmonary embolism Patient at 27 weeks of pregnancy, reported to midwife at regular visit on 4/14/21 that she was exper... Read more
Patient at 27 weeks of pregnancy, reported to midwife at regular visit on 4/14/21 that she was experiencing SOB but all blood work normal - assumed normal SOB with pregnancy. Night/morning of 4/15 started seizures, transported to ED. Diagnosed with massive pulmonary embolism. Emergency C-section prerformed by Dr. Pt. did not survive.
42 2021-04-14 excessive bleeding Subdural Hematoma. Blood bleed
42 2021-04-22 palpitations, chest discomfort Delayed onset (day 4): headache, dizziness and vertigo, brain fog, chest pressure, increased heart p... Read more
Delayed onset (day 4): headache, dizziness and vertigo, brain fog, chest pressure, increased heart palpitations, tinnitus
42 2021-04-24 chest pain, chest discomfort Anaphylactic reaction to vaccine; Felt like an elephant was sitting on my chest; Could not take a de... Read more
Anaphylactic reaction to vaccine; Felt like an elephant was sitting on my chest; Could not take a deep breath; dizzy lightheaded; Had tingling in my feet; headache; chest pains; This is a spontaneous report from a contactable consumer (patient). A 42-years-old non pregnant female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 10Apr2021 10:00 (at the age of 42-year-old) (Batch/Lot Number: Ew0158) as SINGLE DOSE for covid-19 immunisation. Medical history included Asthma, anaphylactic reactions to shellfish, PCN, codeine. Known allergies included: PCN, codeine, nuts, shellfish, potatoes, green beans, apples, tomatoes. Concomitant medication(s) included loratadine (CLARITIN [LORATADINE]) taken for an unspecified indication, start and stop date were not reported; polycarbophil calcium (FIBER) taken for an unspecified indication, start and stop date were not reported; vitamin b complex (B COMPLEX [VITAMIN B COMPLEX]) taken for an unspecified indication, start and stop date were not reported; magnesium (MAGNESIUM) taken for an unspecified indication, start and stop date were not reported; iron (IRON) taken for an unspecified indication, start and stop date were not reported. The patient took Clartin, fiber, b complex, magnesium, iron, probot in two weeks. The patient previously took first dose of bnt162b2 in left arm on 20Mar2021 at 14:15 (lot number=Er2613) for covid-19 immunisation. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. On 11Apr2021 02:00 AM, the patient experienced Anaphylactic reaction to vaccine. Felt like an elephant was sitting on her chest. Could not take a deep breath. She was also dizzy lightheaded. Had tingling in her feet, headache and chest pains. Most of her symptoms went away after she was given a high dose of Benadryl and prednisone. She also has asthma and a history of delayed anaphylactic reactions. It will be a 4-5 days before her lungs completely recover from this. AE Resulted in Emergency room/department or urgent care. Outcome of the events was recovering.
42 2021-04-27 deep vein blood clot, pulmonary embolism DVT; PE; This is a spontaneous report from a contactable physician. A 42-year-old female patient rec... Read more
DVT; PE; This is a spontaneous report from a contactable physician. A 42-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscularly in the left arm, on 28Jan2021 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension (HTN) and fibroids. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies. Concomitant medication included amlodipine besilate (MANUFACTURER UNKNOWN). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscularly in the right arm, on 07Jan2021 (at the age of 42-years-old) for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced deep vein thrombosis (DVT) and pulmonary embolism (PE) on 29Jan2021, which caused hospitalization for 5 days from an unspecified date to an unspecified date. Therapeutic measures were taken as a result of the events, which included direct oral anticoagulants (DOAC). The clinical outcome of DVT and PE was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19. The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect vaccine BNT162B2 or comirnarty in triggering the onset of Deepvein thrombosis,pulmonary embolism cannot be excluded.But also consider relevant medical history of hypertension and fibroids tendency to form blood clots and concomitant medications also have possible contributory role. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
43 2020-12-31 blood clot Soreness at injection site 3 hours post injection. 30 hours post injection, pt experiences a huge bl... Read more
Soreness at injection site 3 hours post injection. 30 hours post injection, pt experiences a huge blood clot from vagina, about the circumference of a clementine. was not old blood, looked like frank blood. over the next 30 hours, pt experiences more clots, much smaller, about the size of a pea. pt has a headache and chills throughout. 48+ hours, experiencing what feels like menstrual cramps. no blood clots 72 hours post injection
43 2021-01-02 palpitations Racing heart, dizziness, lightheadedness
43 2021-01-03 heart rate increased Approx 25 min after injection I became dizzy and my HR went to the 130?s, at around 30 min post inje... Read more
Approx 25 min after injection I became dizzy and my HR went to the 130?s, at around 30 min post injection my tongue started to swell
43 2021-01-03 chest pain First day I had muscle ache. Second day worst muscle pain on my left arm. Fourth Day at 9pm sever c... Read more
First day I had muscle ache. Second day worst muscle pain on my left arm. Fourth Day at 9pm sever chest pain I took Ibuprofen to relive the pain the next morning I had to see the doctor because I had sever pain but not related to the heart .
43 2021-01-03 chest discomfort My arm was sore the 1st day, by noon the next day my HR was 160s, I was referred to go to the ER but... Read more
My arm was sore the 1st day, by noon the next day my HR was 160s, I was referred to go to the ER but I didnt and took benedryl went to sleep, woke up and I felt a little SOB but more like something was tied around my ribs preventing me from breathing. I saw the cardiologist who believed it to be sinus tackycardia as a result as an AE to vaccine. Felt as if my face and lips were swelling so I took benedry and laid down again and the next morning when I woke up and my face and lips were super swollen. But by the 3rd day the symptoms began to subside a little. By the 24th my HR had balanced out and I only had residual swelling around the eye area.
43 2021-01-03 palpitations Pounding heart, fast breathing, warm/tingling in arms/hands, feeling like I might faint.
43 2021-01-04 heart rate increased, palpitations About 2-3 minutes after my vaccination, my heart rate went up, pounding, I got dizzy, dry mouth; Abo... Read more
About 2-3 minutes after my vaccination, my heart rate went up, pounding, I got dizzy, dry mouth; About 2-3 minutes after my vaccination, my heart rate went up, pounding, I got dizzy, dry mouth; About 2-3 minutes after my vaccination, my heart rate went up, pounding, I got dizzy, dry mouth; About 2-3 minutes after my vaccination, my heart rate went up, pounding, I got dizzy, dry mouth; This is a spontaneous report from a contactable other healthcare professional, the patient. A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 21Dec2020 at 13:00 (at the age of 43 years old) as a single dose in the right arm for COVID-19 vaccination. Medical history included supraventricular tachycardia, asthma, seasonal and environmental allergies, anxiety, and allergies to latex, adhesives, ragweed, and Keflex. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included buspirone hydrochloride (BUSPAR), piroxicam (PAXIL), cannabidiol, and levosalbutamol hydrochloride (XOPENEX), all for unknown indications from unknown dates and unknown if ongoing. Past drug history included epinephrine for dental work, where she experienced a similar reaction. The patient did not receive any other vaccines within four weeks prior to the vaccination. The vaccine was given at a hospital. On 21Dec2020, about 2-3 minutes after her vaccination, the patient experienced heart rate went up, pounding, she got dizzy, and dry mouth. She never had a hard time swallowing, no rash. This episode went on for about 2-3 minutes, they provided her a large amount of juice which seemed to help. Then it resolved completely and she finished off her 15 minutes without issue. It happened very suddenly and unexpectedly. The clinical outcome of about 2-3 minutes after her vaccination, her heart rate went up, pounding, she got dizzy, and dry mouth was recovered on 21Dec2020. It was also reported that since the vaccination, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
43 2021-01-04 blood pressure increased Became flushed and described a scratchy swallowing sensation. Blood pressure was elevated. SPO2 re... Read more
Became flushed and described a scratchy swallowing sensation. Blood pressure was elevated. SPO2 remained steady at 98%. Sat with healthcare staff for additional 40 minutes. Benadryl 25mg given.
43 2021-01-04 palpitations Dizziness, nausea, light headedness, palpitations
43 2021-01-04 heart rate increased No appetite; congested head; congested head, cough; headache; fatigue; nausea; about an hour after f... Read more
No appetite; congested head; congested head, cough; headache; fatigue; nausea; about an hour after flush, increased heart rate, very jittery - able to continue to work but unpleasant; about an hour after flush, increased heart rate, very jittery - able to continue to work but unpleasant; about an hour after flush, increased heart rate, very jittery - able to continue to work but unpleasant; This is a spontaneous report from a contactable other health care professional. A 43-year-old female patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on 18Dec2020 11:00 at single dose at arm (pending clarification) for COVID-19 immunization. Medical history included asthma, allergies, depression, penicillin allergy, allergies to: Mangoes, Cashews, Peaches. Concomitant medications included sertraline hydrochloride (ZOLOFT), montelukast sodium (SINGULAIR), fexofenadine hydrochloride (ALLEGRA), fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]). The patient previously took amoxicillin and experienced known allergies: Amoxicillin. On 18Dec2020: about an hour after flush, increased heart rate, very jittery - able to continue to work but unpleasant. Lasted about an hour. On 19Dec2020: afternoon - headache, nausea, fatigue started. On 20Dec2020: continued to feel fatigued and same symptoms. On 21Dec2020: headache, waves of nausea along with feeling flush (no fever ever) and elevated heart rate. On 22Dec2020: Same. The patient continued to work through all this but felt lousy. On 23Dec2020: stayed home from work because work wanted the patient to take a Covid Test (this was negative) - so laid around. Still with headache and nausea, easily fatigued. Cough started PM. On 24Dec2020: no nausea but continued headache, congested head, cough. On 25Dec2020: feeling better. No appetite. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient been tested for COVID-19, and was negative on 23Dec2020. The outcome of the events was recovered. The patient did not receive treatment for the events. Information about lot/batch number has been requested.
43 2021-01-04 heart rate increased, palpitations, blood pressure increased Rushing feeling-hands turned red and warm and face turned red and warm; Rushing feeling-hands turned... Read more
Rushing feeling-hands turned red and warm and face turned red and warm; Rushing feeling-hands turned red and warm and face turned red and warm; redness of hands; Rushing feeling-hands turned red and warm and face turned red and warm; Palpitations-increases heart rate; Palpitations-increases heart rate; Increased blood pressure; This is a spontaneous report from a contactable Nurse. A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 24Dec2020 at 04:15 (at the age of 43-years-old) at an unspecified dose in the left arm for COVID-19 vaccination. The patient's medical history was not reported. The patient was allergic to morphine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. The patient was administered the vaccine in a workplace clinic. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Dec2020 at 04:30 the patient experienced a rushing feeling during which her hands turned red and warm and her face turned red and warm. At this same time, she also experienced increased blood pressure, palpitations and increases in her heart. The patient did not receive any treatment for the events. The clinical outcomes of rushing feeling during which her hands and face were warm and turned red, increased blood pressure, palpitations, increased heart rate were reported as recovered on an unspecified date in Dec2020. It was also reported that since the vaccination the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
43 2021-01-04 heart rate increased, hypertension, pallor fever; Nausea; suddenly felt there was something hot going through my body; suddenly felt there was ... Read more
fever; Nausea; suddenly felt there was something hot going through my body; suddenly felt there was something hot going through my body; She said she felt a wave of heat going through her blood vessel, and her legs and arms felt hot.; It made it hard to breathe; felt like a rush of hot and felt horrible; My heart rate and BP was high; My heart rate and BP was high; she looked pale, and did not have rashes; This is a spontaneous report from a contactable Other HCP reporting for herself A 43-years-old female patient received bnt162b2 (BNT162B2; Lot # EH9899) vaccine , via an unspecified route of administration on 26Dec2020 10:15 at single dose for Covid-19 immunisation . Medical history included thyroid cancer from 2009 , blood calcium decreased from an unknown date , depression from an unknown date , anxiety from an unknown date. Concomitant medication included cetirizine hydrochloride (ZYRTEC) [fluoxetine (FLUOXETINE), calcium carbonate, colecalciferol, menaquinone (VITAMIN K2 + VITAMIN D3 + CALCIUM), calcium carbonate (TUMS) vitamin C (VITAMIN C) , vitamin D2 (VITAMIN D2), levothyroxine sodium (SYNTHROID). On 26Dec2020, about thirty minutes after receiving the vaccine the patient suddenly felt there was something hot going through her body it made it hard to breathe , felt like a rush of hot and felt horrible , her heart rate and BP were high, she said she felt a wave of heat going through her blood vessel, and her legs and arms felt hot. , she looked pale, and did not have rashes. The patient believed she was having an allergic reaction and gave a shot of epinephrine before going to ER. The doctors told her that her oxygen was fine (SatO2: 98%) and therefore she was not having an allergic reaction. She felt like she had trouble breathing. Her heart rate would go up to 120 to 150. Her blood pressure was high. She also received a shot of lorazepam (ATIVAN) at about 15:30 on 26Dec2020. She went bed and woke up on 27Dec2020, she had fever at 99.4°F and had nausea. The outcome of the reported events was unknown. The patient stated this was a terrible experience and she felt like she was going to die. Also she is not going to receive the second shot of the vaccine.
43 2021-01-05 heart rate increased Elevated HR up to 130 for a few hrs after administration and intermittently for several days; Severe... Read more
Elevated HR up to 130 for a few hrs after administration and intermittently for several days; Severe fatigue; This is a spontaneous report from a contactable nurse. A 43-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: eh9899, expiry date not reported), intramuscular on the left arm on 16Dec2020 12:00 at single dose for COVID-19 immunisation. Medical history included asthma. Concomitant medications were not reported. On 16Dec2020 14:00, the patient experienced elevated HR up to 130 for a few hours after administration and intermittently for several days and severe fatigue. No therapeutic measure was taken as a result of the events. Clinical outcome of the events was recovered with sequelae on Dec2020. Follow-up attempts are not possible. No further information is expected.
43 2021-01-06 chest discomfort ED Note: This is a 43-year-old female with history of asthma who presents for evaluation of chest ti... Read more
ED Note: This is a 43-year-old female with history of asthma who presents for evaluation of chest tightness. The patient is an employee and received her COVID-19 vaccine, first dose 20 minutes prior to ED arrival. She subsequently developed chest tightness and wheezing. She used he albuterol r inhaler and now feels improved. She says that she has been having increased asthma exacerbations lately because of the change in weather. She has had no prior allergic reaction to any vaccine. She denies any hives. Denies any throat tightness. Her symptoms at this point have resolved. Monitored in ED x 4 hrs. No treatment.
43 2021-01-06 fast heart rate Immediate flushing of skin, tachycardia, impaired cognition
43 2021-01-06 palpitations heart palpitations starting 3 days after receiving vaccine; This is a spontaneous report from a cont... Read more
heart palpitations starting 3 days after receiving vaccine; This is a spontaneous report from a contactable Nurse reporting for self. A 43-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscularly on 18Dec2020 08:45 as a single dose (Dose 1), right arm (age at vaccination 42-years old) for COVID-19 immunization. The patient is not pregnant and did not receive any other vaccine in the 4 weeks prior to the COVID-19 vaccine. Medical history included diabetes mellitus, drug hypersensitivity, and allergies sulfa. the patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included omeprazole (PRILOSEC), aripiprazole (ABILIFY), zolpidem tartrate (AMBIEN), famciclovir (FAMVIR), semaglutide (OZEMPIC), and cetirizine hydrochloride (ZYRTEC). On 21Dec2020 at 16:00, the patient experienced heart palpitations starting 3 days after receiving vaccine. The event was reported as non-serious. No treatment was received for the event. The palpitations were resolving. The patient wasn't COVID tested post-vaccination. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
43 2021-01-07 fast heart rate, hypertension Angioedema, HYPERtension & Tachycardia Acute mild allergic reaction //Patient placed in a cardiac mo... Read more
Angioedema, HYPERtension & Tachycardia Acute mild allergic reaction //Patient placed in a cardiac monitor //Given Solu-Medrol as well as Pepcid //No evidence of anaphylaxis, epinephrine is not indicated at this time //No worsening of sx. vs improved. //will DC home with steroids.
43 2021-01-07 fast heart rate Dizziness, NauseaVomiting, Tachycardia, Pt reported feeling "heaviness" in legs "can't move" and "le... Read more
Dizziness, NauseaVomiting, Tachycardia, Pt reported feeling "heaviness" in legs "can't move" and "left eye feels funny, like twitching and my blood pressure feels high" Narrative: Pt reports high anxiety along with stated symptoms.
43 2021-01-07 hypotension FATIGUE, MALAISE, INJECTION SITE PAIN, VERTIGO, HYPOTENSION
43 2021-01-07 chest discomfort I had pretty severe symptoms about 12 hours after the vaccine. I received the vaccine on 1/6 at 8 am... Read more
I had pretty severe symptoms about 12 hours after the vaccine. I received the vaccine on 1/6 at 8 am. Serve headache, body aches, chill, fever. They lasted about 12 hours and then most of today just overall fatigue. I now have discomfort in my back and chest. Is this normal?
43 2021-01-07 blood pressure increased, heart rate increased Itching and redness over whole body/I turned all red and was itching all over my body by about 10:30... Read more
Itching and redness over whole body/I turned all red and was itching all over my body by about 10:30- 10:45 am/I still have mild itching; Itching and redness over whole body/I turned all red and was itching all over my body by about 10:30- 10:45 am/I still have mild itching; Elevated heart rate and blood pressure; Elevated heart rate and blood pressure; Had an allergic reaction; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female patient received the first dose of bnt162b2 (BNT162B2) lot no: EK9231, via an unspecified route of administration in left arm on 30Dec2020 09:00 at a single dose for COVID-19 immunization. Medical history HTN and exercise-induced asthma, both from an unspecified date and unknown if ongoing. The patient was not pregnant at the time of vaccination. The patient had no covid prior to vaccination and was not covid tested post vaccination. Concomitant medication included colecalciferol (VITAMIN D), montelukast sodium (SINGULAIR), and biotin. No other vaccines were administered in four weeks. Known allergies include tapendalol (NUCYNTA) and trimethoprim/sulfamethoxazole (BACTRIM). On 30Dec2020 09:30, the patient experienced itching and redness over whole body, elevated heart rate, and blood pressure. The patient was given IV diphenhydramine (BENADRYL) 50 mg, IV famotidine (PEPCID), IV methylprednisolone (SOLU MEDROL), "flui" as treatment for AEs. The patient further clarified that she received the COVID 19 vaccine on 30Dec2020 at 9:00 and she had an allergic reaction. She turned all red and was itching all over her body by about 10:30- 10:45 am and was at the ER by about 11am. She started on prednisone 40mg for 3 days and diphenhydramine every 6 hours, as needed on 30Dec2020. On Sunday (03Jan2021), she was still severely itching and turning red so prednisone was continued for an additional 3 days and was switched to cetirizine (ZYRTEC) because she can't function on diphenhydramine. Cetirizine was not helping so she had to take diphenhydramine yesterday morning (04Jan2021). Last night (04Jan2021), she was ok without any diphenhydramine but this morning (05Jan2021), she still have mild itching, and no redness. The redness comes and goes; it is on the face, chest, arms, legs. When it first started, it was whole body redness. Then it moved to different areas on different days; she don't have a rash or hives, just redness. She had a 4 inch band of redness on both arms one day. The events were reported as non-serious. The patient had not recovered from the events.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of allergic reactions cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product. The underlying predisposing condition of drug allergies to multiple materials may put the patient at high risk of allergic reactions. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
43 2021-01-07 hypertension RespDepression & HYPERtension Narrative: Employee reported difficulty breathing within 15 minutes of... Read more
RespDepression & HYPERtension Narrative: Employee reported difficulty breathing within 15 minutes of vaccine administration. She was given oral Benadryl and one dose of epinephrine per epi pen. She was taken to the ER for further evaluation.
43 2021-01-07 heart rate increased extremely high heart rate (142bpm); muscle aches; chills; O2 sats "dropped to 97%"; This is a sponta... Read more
extremely high heart rate (142bpm); muscle aches; chills; O2 sats "dropped to 97%"; This is a spontaneous report from a contactable healthcare professional (HCP) for herself. A 43-year-old female patient received first dose of BNT162B2 (Pfizer/ BioNTech Covid-19 vaccine) at a single dose on 28Dec2020 at 13:30 for Covid-19 immunization. The patient had recently diagnosed with Covid-19 and "recover/off quarantine" on 12Dec2020. Concomitant medications were not reported. After vaccination, the patient experienced extremely high heart rate (142bpm), muscle aches, chills, O2 saturation dropped to 97%. The patient did seek medication attention/went to ER. She had to miss work. High heart rate resolved on the same day and other events resolved after 48 hours. The patient stated that she believed she took it too soon because she still had the antibodies from Covid, the doctors were saying they were not sure it was from vaccine, but she was sure it was. The patient made up her mind to not take the 2nd dose as she was scared. She stated that she did not want to go through that again, she could have had cardiac arrest. Information on the lot/batch number has been requested.
43 2021-01-07 palpitations increased new palpitations/an increase in the amount of chest palpitations; This is a spontaneous re... Read more
increased new palpitations/an increase in the amount of chest palpitations; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female patient receive the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number EH9899), intramuscular on the left deltoid on 29Dec2020 at SINGLE DOSE as COVID prevention at the hospital. Medical history included ongoing hypothyroidism for about 3 or 4 years, sinus headache, and ear pressure. It was reported that the patient had palpitations in the past but has not had any recently. Concomitant medications included ongoing liothyronine sodium (CYTOMEL) for hypothyroidism and phenylephrine (PHENYLEPHRINE) from unknown date until 31Dec2020 for ear pressure and sinus headache. The patient had her first dose of the COVID vaccine on 29Dec2020 and she had no problems at first, but she stated that she was seeing an increase in the amount of chest palpitations that she was having since 31Dec2020. She knew it was cold and fly season (uncommon for her to have ear pressure and headaches with weather changes) and she had to take some sinus medicines, so she just blew the palpitations off as having come from those sinus medicines but she was no longer taking those medicines and the palpitations were still persisting. The patient also mentioned that she was watching her caffeine intake, and she even was not having any more caffeine than she normally does. She really noticed the palpitations over the holiday weekend, and it felt like it was getting worse, and then she started feeling like she needed to reset herself. Outcome of the event was not recovered. As per causality, the patient also mentioned that it was unknown if the palpitations were caused by the vaccine, but she feared that they were. She also mentioned that she had no other vaccines on the same day as the COVID Vaccine so she was not sure.
43 2021-01-08 fibrin d dimer increased Generalized edema, shortness of breath, change in taste
43 2021-01-09 chest discomfort Dry cough, itchy throat, wheezing, SOB, heaviness in chest, headache. Resolved about two hours later... Read more
Dry cough, itchy throat, wheezing, SOB, heaviness in chest, headache. Resolved about two hours later after taking Benadryl and aleve.
43 2021-01-09 nosebleed fatigue and body aches developed about 12 hours after 1st injection which resolved after two days. A... Read more
fatigue and body aches developed about 12 hours after 1st injection which resolved after two days. About 3-4 days after injection had stuffy nose with extreme dryness and sores throughout both nasal passage resulting in epistaxis. It has been over 1 week without resolution of sores despite keep nasal passages moist and running humidifer.
43 2021-01-10 chest pain Friday evening - arm soreness, headache, Saturday morning - achy, chest pain, shoulder pain, shortne... Read more
Friday evening - arm soreness, headache, Saturday morning - achy, chest pain, shoulder pain, shortness of breath, fatigue - all resolved
43 2021-01-10 chest discomfort Left side burning. Flushed, Lightheaded, Heaviness in her Chest Tylenol
43 2021-01-11 blood pressure increased Patient presented approximately 25 minutes following vaccine dose with swelling of her upper lip and... Read more
Patient presented approximately 25 minutes following vaccine dose with swelling of her upper lip and tingling to the roof of her mouth, tongue, and upper lip. Vital signs with mildly elevated blood pressure at 132/80, oxygen saturation 99%, and pulse 72. She was given diphenhydramine (Benadryl) 50 mg by mouth as a single dose and water to drink. She was observed for 30 minutes and symptoms gradually improved. Vital signs after 30 minutes of observation with blood pressure 120/78, oxygen saturation 100%, and pulse 61. She had her husband come to drive her home due to receiving a dose of Benadryl and due to the potential for drowsiness with this medication. She was instructed to take another dose of Benadryl in 6-8 hours if her symptoms continue to persist. She states that her husband will be home with her for the remainder of the day and will observe her and seek medical attention if needed. She was also instructed to follow up with her primary care provider if symptoms persist beyond the next few hours today and certainly if they persist following a second dose of Benadryl in 6-8 hours. She expressed understanding. She stated that she was comfortable going home and continuing to monitor her symptoms.
43 2021-01-11 fast heart rate first day after shot, nausea, body aches, 2nd day Sunday headache, Monday 5 am woke up itching, the... Read more
first day after shot, nausea, body aches, 2nd day Sunday headache, Monday 5 am woke up itching, then 9 am hives everywhere, trouble breathing, anaphylaxis, went to ER, got epi X 2, solumedrol, benadryl, pepcid, then still with hives, tachycardia, dyspnea, iv fluids were influsing and epi drip started, went to ICU
43 2021-01-12 hypertension, chest pain HYPERtension chest pain (mild), anxiety
43 2021-01-12 chest discomfort, chest pain I?m not sure if this is in my head but I think the vaccine has flared up my reflux. I received firs... Read more
I?m not sure if this is in my head but I think the vaccine has flared up my reflux. I received first dose on 12/23/2020 and second dose on 1/10/2021. Since vaccine I?ve noticed my reflux has been flared. I haven?t had to take Protonix in months; however, I really started to experience indigestion and chest burning/pressure a week after first dose. I started back taking Protonix and had to increase dose to twice a day on 1/5/2021. Symptoms have improved significantly but it?s still somewhat aggravated. I also experienced lower back pain and upper and lower extremities numbness/tingling maybe 2-3 time since first vaccine
43 2021-01-12 palpitations Pfizer-BioNTech COVID-19 Vaccine Patient received 2nd dose of Pfizer-BioNTech vaccine on 1/8/2021 at... Read more
Pfizer-BioNTech COVID-19 Vaccine Patient received 2nd dose of Pfizer-BioNTech vaccine on 1/8/2021 at 8:23am and 5 minutes later she experienced palpitations. HR 150 -190. Sent to ED for evaluation at 8:37am. In ED, her HR was in the 90s and patient feeling better. BP 134/95. No further treatment. Patient discharged at 9:13am
43 2021-01-13 pallor Began with tingling/itching to tongue and roof of mouth approx 15 minutes after administration, prog... Read more
Began with tingling/itching to tongue and roof of mouth approx 15 minutes after administration, progressed to tingling of lips, was sent to the ED for observation. Within 20-30 minutes developed cough, throat tightness, difficulty swallowing, breathing, vomiting, shortness of breath. Noted to have uvular swelling and wheezing on examination. Given Benadryl, Pepcid, Solumedrol, Zofran, Albuterol MDI, Epi IM. within a few minutes symptoms returned and were worse where I felt like I could not breathe, throat was closing, could not talk. Noted to be pale, HR in 140?s. Given second dose of epi IM and symptoms improved. Was transferred to Obs Unit., within 2 hours (approx 6 hours after administration), developed SOB, throat tightness, cough, vomiting, difficulty breathing. Again noted to have swelling of uvula, wheezing on exam. Given Solumedrol, Benadryl, SQ epi, Albuterol, Racemic Epi nebulizer. Was transferred to ICU, all meds held except Pepcid. Day #2 ~10 am (25 hours from administration) developed throat tightness, diffuse red rash to arms, difficulty breathing, vomiting. Again noted to have uvular swelling and wheezing. Given Solumedrol, Benadryl, Pepcid, Albuterol MDI, Racemic Epi neb. Solumedrol started q12hour dosing. Strange feeling/fullness in throat continued all day, got additional racemic Epi neb that night with improvement of symptoms. Following morning (day#2 after vaccine) noted to have diffuse red rash to chest and face, spread to arms, then began coughing. Given Solumedrol, Pepcid, Benadryl, Advair, Racemic Epi nebulizer. Solumedrol changed to q8 dosing. Approx 4 hrs later nurse noted rash worse on face, associated with itching, throat tightness. Given additional Benadryl, Racemic Epi neb with improvement. Rash continued that night with throat tightness, got additional Benadryl and Racemic Neb that night (total of 3 Racemic nebulizer on Day#2 post vaccine). Transferred to telemetry floor. Day#3 post vaccine rash improved, but still present to chest and face. Throat fullness present, especially after drinking. Am still hospitalized while writing this report
43 2021-01-13 heart rate increased I felt dizzy as soon as I got the vaccine. My heart rate increased but nothing to worry about. It to... Read more
I felt dizzy as soon as I got the vaccine. My heart rate increased but nothing to worry about. It took me at least 30 min to feel myself. That afternoon I felt L hip pinching pains and joints pain. A week later I had sudden vertigo , unable to walk normally with no tinnitus or loss of hearing . I took meclizine 50 mg and it helped. It?s already day 5 , vertigo has subsided , I still don?t feel myself but I am able to go around, drive and move. I only feel dizzy at times and feel vertigo when laying down
43 2021-01-13 chest discomfort, palpitations Patient started feeling shaky and felt weak, said chest felt heavy and felt like her heart was beat... Read more
Patient started feeling shaky and felt weak, said chest felt heavy and felt like her heart was beating fast. She also said that arms and feet felt "tingly". Patient felt this immediately after injection upon standing. Patient was escorted to chair for assessment. She was given water and pulse was normal. Patient said that she was feeling a bit better after a couple of minutes but then started experiencing chest heaviness and shakiness again. Patient alert, oriented, pulse normal, respirations normal. ER called and nurse came to clinic for assessment. Pulse was still normal upon his assessment but offered to take patient to ER via wheelchair for further assessment and patient agreed. Patient left clinic at approximately 8:55am to go to ER.
43 2021-01-13 chest pain Right sided chest pain and shortness of breath 2 hours after vaccine administration. Patient was exa... Read more
Right sided chest pain and shortness of breath 2 hours after vaccine administration. Patient was examined in ER. CT of chest showed "questionable minimal small airway inflammation in upper lobes". Patient was discharged from ER home with Methocarbamol 750mg PO Q12 hours as needed.
43 2021-01-13 chest discomfort arm is red, warm, and itchy; arm is red, warm, and itchy; arm is red, warm, and itchy; Chest tightne... Read more
arm is red, warm, and itchy; arm is red, warm, and itchy; arm is red, warm, and itchy; Chest tightness; bitter taste in her mouth; funny feeling; arm was hurting; swelling; patient thinks the vaccine was given to her subcutaneously instead of intramuscularly; This is a spontaneous report from a contactable nurse (reporting for herself). A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EK9231), subcutaneously in the left arm on 05Jan2021 15:00 at 0.3 mL, single for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included an unspecified multivitamin, taken at one tablet daily by mouth for supplementation therapy. The patient previously took the flu vaccine (MANUFACTURER UNKNOWN) in 2016 for immunization and experienced chest tightness, which she took diphenhydramine hydrochloride (BENADRYL). The patient experienced arm is red, warm, and itchy on 05Jan2021, which was reported as being medically significant. On 05Jan2021, the patient experienced chest tightness, bitter taste in her mouth, funny feeling, arm was hurting, swelling and patient thinks the vaccine was given to her subcutaneously instead of intramuscularly. On 06Jan2021, the patient experienced arm is red, warm, and itchy was reported as worsened. The outcome of arm is red, warm, and itchy, chest tightness and arm is red, warm, and itchy was reported as worsened was not recovered and of bitter taste in her mouth, funny feeling, arm was hurting, swelling and patient thinks the vaccine was given to her subcutaneously instead of intramuscularly was unknown. The reporter assessed the relatedness to the event, arm is red, warm, and itchy to the Covid-19 Vaccine as related; Sender's Comments: Based on the time association, the possible contribution of suspect BNT162B2 to the events pruritus, erythema and feeling hot cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
43 2021-01-13 heart rate irregular fever, aches, head pain, elevated heartrate, fatigue for 24- 48 hrs, elevated hr still intermittent
43 2021-01-14 fast heart rate 5 minutes after receiving dose 2 of Pfizer COVID-19 vaccine started getting hives rash shortness of ... Read more
5 minutes after receiving dose 2 of Pfizer COVID-19 vaccine started getting hives rash shortness of breath tachycardia, nausea. Taken to ER and given IM Epi, IV Benadryl, Solumedrol, Pepsi?s, albuterol and racemic epi breathing treatments and put on Epinephrine IV drip to treat anaphylactic reaction
43 2021-01-14 deep vein blood clot Hospital Course:   Patient is a 43 y.o. female patient who originally presented to the hospital on... Read more
Hospital Course:   Patient is a 43 y.o. female patient who originally presented to the hospital on 1/3/2021 due to Left lower extremity pain and swelling. Patient found to have extensive DVT of left lower extremity and started on heparin drip. Vascular was consulted and recommended thrombolysis. Patient was also seen by IR who took patient for thrombectomy and left iliac stent placement on 01/05/2021. Patient tolerated procedure well. Patient was transitioned from heparin drip to Eliquis upon discharge. Patient given vascular follow-up as well as Hematology follow-up.
43 2021-01-14 hypertension On 1/9/21, patient reported to urgent care for lower back pain. Patient also reported chills, adenop... Read more
On 1/9/21, patient reported to urgent care for lower back pain. Patient also reported chills, adenopathy, headache, and hypertension. Patient was given prescription of diclofenac and cyclobenzaprine. No further escalation of care.
43 2021-01-14 chest discomfort Patient experienced chest tightness after her first COVID vaccine dose. Pt reported similar reactio... Read more
Patient experienced chest tightness after her first COVID vaccine dose. Pt reported similar reactions to vaccines in the past.
43 2021-01-14 palpitations Patient to ED for evaluation of symptoms after a Covid vaccine earlier today. She had her second Co... Read more
Patient to ED for evaluation of symptoms after a Covid vaccine earlier today. She had her second Covid vaccine here at the hospital where she works about 8:30 AM. About 10:00 she started having shakes and a headache and just not feeling right. She has had some periods of palpitations and feeling like her heart is racing as well. She called employee health and was referred in to see us. At this time she says she still has some headache and overall feels weird but no other new symptoms. No chest pain or shortness of breath or palpitations at this time. No trouble breathing. No fever. No visual changes but the light does bother her eyes. She does have a history of migraine headaches that are like this at times. The pain is in her forehead, not globally or in her neck. She has no neck pain or stiffness. She did not have much of reaction after her first vaccination. She does have a history of hypertension but has been taken off her medication because her blood pressures have been well controlled. She states that she does check them regularly at home and they have been okay. She denies any other recent sick symptoms. No other significant chronic underlying medical problems. Medications administered in the ED included ibuprofen 600mg and diphenhydramine 25mg orally at 1415, and acetaminophen 1000mg orally at 1000mg. Headache was better at 1540, blood pressure was lower at 139/90, no shaking. Pt discharged home.
43 2021-01-14 chest discomfort Symptoms - ? Patient reports approx. 1 hour after vaccination, burning at injection site and burning... Read more
Symptoms - ? Patient reports approx. 1 hour after vaccination, burning at injection site and burning sensation up her arm and behind her L ear. Approx. 4 hours after vaccine, + fatigue, abd pain, abd cramping and chest tightness. Patient report cardiac hx. + nausea and feeling ?flu like?. Patient called off of work the night of 13th and 14th due to feeling unwell. Patient denies fever. At time of call, patient reports still feeling very fatigued, congested and abd pain/cramping. Patient denies COVID-19 exposure without proper PPE and travel. Last day of work and shift - ? 1/12 (night shift) Home remedies? - rest Any improvement? ? mild improvement Recommendation? Patient has been referred for testing. Patient reports previously tested in March (negative result). Patient encouraged to remain quarantine at home and to contact EH command center for assistance with testing. Patient verbalized back understanding and denied further questions at this time.
43 2021-01-14 chest discomfort Symptoms - ? patient reports approx. 1 hour after vaccination, burning at injection site and burning... Read more
Symptoms - ? patient reports approx. 1 hour after vaccination, burning at injection site and burning sensation up her arm and behind her L ear. Approx. 4 hours after vaccine, + fatigue, abd pain, abd cramping and chest tightness. Patient report cardiac hx. + nausea and feeling ?flu like?. Patient called off of work the night of 13th and 14th due to feeling unwell. Patient denies fever. At time of call, patient reports still feeling very fatigued, congested and abd pain/cramping. Patient denies COVID-19 exposure without proper PPE and travel. Last day of work and shift - ? 1/12 (night shift) Home remedies? - rest Any improvement? ? mild improvement Recommendation? Patient has been referred for testing. Patient reports previously tested in March (negative result). Patient encouraged to remain quarantine at home and to contact EH command center for assistance with testing. Patient verbalized back understanding and denied further questions at this time.
43 2021-01-15 blood pressure increased Right arm cold feeling progressed to neck and legs. Tried to return to facility after 25 minute int... Read more
Right arm cold feeling progressed to neck and legs. Tried to return to facility after 25 minute interval after the vaccination. Then felt faint and called 911 who responded reported passed out while on 911 dispatch.
43 2021-01-16 chest pain Shortness of breath Sp02 in high 80s Chest pains Severe pain everywhere Exhusted Inability to m... Read more
Shortness of breath Sp02 in high 80s Chest pains Severe pain everywhere Exhusted Inability to move with out shaking
43 2021-01-17 nosebleed Fever for 5 days; rash on neck; body aches; sore throat; bloody nose; cough; fatigue; This is a spon... Read more
Fever for 5 days; rash on neck; body aches; sore throat; bloody nose; cough; fatigue; This is a spontaneous report from a contactable nurse. A 43-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscularly on 05Jan2021 08:00 at single dose for COVID-19 immunization. The patient medical history was not reported. No known allergies. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), zolpidem tartrate (AMBIEN), cyanocobalamin (B12), lamotrigine (LAMICTAL), paracetamol (TYLENOL), vilazodone hydrochloride (VIIBRYD), colecalciferol (VITAMIN D). The patient experienced fever for 5 days, rash on neck, body aches, sore throat, bloody nose, cough, fatigue, all on 06Jan2021 04:00. The adverse events resulted in Emergency room/department or urgent care. No treatment received. This is a non-serious repot. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19: Nasal Swab on 08Jan2021, test name: PCR, pending result. The outcome of the events was recovering. Information on the lot/batch number has been requested.
43 2021-01-17 palpitations, heart rate increased Received vaccine on 1/4 in the morning and it was fine until the evening, then got the sore site and... Read more
Received vaccine on 1/4 in the morning and it was fine until the evening, then got the sore site and mild malaise, wen to be early and slept all night. Next several days feeling extra tired especially in the evenings. On 1/12 I got up at 05:30 feeling fatigued and super tired, i call out work. I slept for most of the day and called occupational health (OH) and they scheduled a PCR Covid test for the next day 1/13, which came back negative. (1/14) still feeling fatigued, having palpitations and noticed my heart rate increasing significantly with mild exertion such as walking and eating, so I reached out to my PCP, who ordered labs and a second PCR Covid test for 1/15. Labs returned the next day 1/15 with elevated WBC and second Covid test came back negative on 1/16. Felt a bit better on Sunday 1/17, but today 1/18, I am still very tired and my heart continues to increase when I get out of bed, eat, shower or do any simple thing, my heart rate jumps from 64-68 to 115-120s, called my PCP back and he is seeing me tomorrow morning for an EKG and other tests, and I have been out of work for a week. I take no prescriptions drugs and have no health problems.
43 2021-01-17 fast heart rate, hypertension Three hours after I received Vaccine I became extremely dizzy , had shortness of breath, was tachyc... Read more
Three hours after I received Vaccine I became extremely dizzy , had shortness of breath, was tachycardic and hypertensive. I was taken to the Emergency room . 48 hours after exam I had extreme periods of confusion and extreme forgetfulness.
43 2021-01-17 chest pain, chest discomfort, palpitations Within 30 minutes of shot-Fleeting itching in both ears, fingertips, and soles of feet. Blurred per... Read more
Within 30 minutes of shot-Fleeting itching in both ears, fingertips, and soles of feet. Blurred peripheral vision in left eye only. Dizziness, wooziness. All resolved with 35 minutes of injection, initially. Within 4 hours of shot-Exponential increase in pain from waist down, including lower back pain. Took Motrin 600 mgs which resolved pain within 1 hour of taking it. Felt off/not myself-Felt foggy-headed-pressure in head and ears was not normal. 2100-0000 (Evening of shot)-Moderate sporadic dizziness that became moderate constant dizziness-Took 1 25 mg chewable Meclizine with 1 cup of water. Pain increased and Motrin wore off. Fatigue grew worse. 1/13/21-1/14/21-SEVERE back pain. Intense pain in legs and hips. Upper respiratory symptoms-Nasal congestion, ear pressure, sinus pain/pressure, chest and upper back discomfort, chest congestion, irritation, and aching. Cheeks and nose looked puffy/swollen. Eye pain, headache on and off. Fatigue, dragging. Felt feverish but no actual fever. Body aches-sides, legs-front, back, and sides, lower back, and glutes. Felt like arthritis from waist down, including lower back. Took nighttime cold syrup, etc. to be able to sleep and/or at least dull the pain. Also used heating massage pad to assist with pain relief. 1/15/21-1/16/21-Pain lessened in terms of intensity. Had longer spells of less intense pain. Also less pain with movement after resting/lying down. However, pain still intense at this point. Meds more helpful with the pain at this point as well. On Sat, felt dizzy and unwell all day, including extra tired. Hot, sweaty on Sat. Racing heart, chest tightness. Used inhaler and Metoprolol. 1/17/21-Felt unwell-intense pain still, dizziness, fatigue. Took Meclizine 25 mg that morning. Also took another 25 mg Meclizine later that afternoon. Nausea, dry heaving to the point I almost vomited 2x. After napping, nausea returned slightly but immediately went away. Felt very tired remainder of the evening. 1/18/21-Went to MD to get clearance to return to work. Dizziness prior to visit and took 1/2 25 mg Meclizine. Felt better until I got to doctor's office. While waiting to be called back, dizziness started up again and got severe. While waiting on MD to come in and talk to me, I got nauseated and felt like I might dry heave/vomit. I took another 1/2 Meclizine 25 mg and sucked on a mentholated cough drop to help with nausea, which did subside. Dizziness continued to be severe. MD took blood pressure, pulse ox, checked my ears, checked my pupils, listened to me breathe, asked me about my symptoms, return to work, and advised on safety of taking 2nd COVID injection when it is time but leaving it up to me in terms of if I feel benefits outweigh possible side effects of 2nd injection. He prescribed anti-nausea meds, pain meds, and stated he wants to see me for a follow-up visit in 1 week. He also prescribed steroid and pain med injections to be administered in office immediately, steroid injection sometimes contains Benadryl and based on how I felt after the shot, there may have been Benadryl in this one. He also requested I message him later in the day to let him know how I was feeling. Injections did GREATLY assist with pain and dizziness/foggy-headed feeling, once they kicked in. I did message him letting him know how I was feeling after napping. 1/18/21 evening-I am still feeling weak and tired and having stinging like pain in both legs along with minor lower back pain. Some chest and throat irritation as well as stomach discomfort. Going to take a gentle laxative as well as some of the nighttime cold medicine I purchased. Still also having dizziness on and off. I plan to return to work tentatively, on 1/19/21, per my return to work note from MD. I will keep my MD notified of how I feel between now and next Monday's follow-up.
43 2021-01-18 cerebrovascular accident Hospitalized for stroke on 31Dec two days after vaccine.; sudden loss of hearing to right ear; dizzy... Read more
Hospitalized for stroke on 31Dec two days after vaccine.; sudden loss of hearing to right ear; dizzy and lightheaded/severe dizziness/felt like fainting; difficulty breathing; vomiting; This is a spontaneous report from a contactable nurse (patient). This 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (Lot number: EL1285) via intramuscular route on 29Dec2020 14:30 at single dose on the left arm for COVID-19 immunization. Medical history included anxiety. No known allergies. Concomitant medications were not reported. Patient was not pregnant. Facility type vaccine was Nursing Home/Senior Living Facility. No other vaccine received in four weeks. Patient hospitalized for stroke on 31Dec2020 two days after vaccine (Days of hospitalization: 4). Day of vaccine-6 hours after patient had dizzy and lightheaded for about 45 min then went away. On 31Dec2020 at 19:15 had sudden loss of hearing to right ear and severe dizziness, difficulty breathing, vomiting, and felt like fainting. Paramedics were called-sent to ER, had CTA which showed partial blockage and received TPA. Treatment included TPA, fluids, medications, hospital stay, outpatient follow ups, physical therapy. Patient was not diagnosed with COVID prior to vaccination. Patient has been tested for COVID post vaccination. The patient underwent lab tests and procedures which included Nasal Swab: Negative and Pixel: Negative on 08Jan2021. Outcome of the events was recovering.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported events including stroke, dizzy/lightheaded/felt like fainting, difficulty breathing, vomiting, and sudden loss of hearing to right, and the administration of the COVID-19 vaccine, BNT162B2. More information regarding the patient's underlying medical conditions, relevant lab tests would be helpful for the Company to make a more meaningful causality assessment.
43 2021-01-18 chest discomfort, palpitations Palpitations and mild chest discomfort Palpitations have been intermittent throughout the day but o... Read more
Palpitations and mild chest discomfort Palpitations have been intermittent throughout the day but occur all day long - few beats stop and then recur Some midsternal chest discomfort non radiating at rest The only change that would have occurred is the vaccine
43 2021-01-19 chest discomfort Patient called to report a severe reaction today, 1/20/21. She stated approximately 12 hours after s... Read more
Patient called to report a severe reaction today, 1/20/21. She stated approximately 12 hours after she received the vaccine, she began having severe chills and muscle aches with fever up to 102.6 that did not respond to Tylenol. Also had headache, vomiting, fatigue, shortness of breath, and chest tightness. After approximately 12-18 hours, her symptoms started improving, but still having mild to moderate muscle aches, fatigue, and shortness of breath. Using albuterol prn. Currently recovering at home.
43 2021-01-19 blood pressure increased Started itching within (left arm) 15 minutes. THey said I was fine and to go back to work. About an ... Read more
Started itching within (left arm) 15 minutes. THey said I was fine and to go back to work. About an hour later, I started breaking out in hives and whole body itching. I went back in and they gave me to full strength Benadryl and it was not helping and my BP was 190/140 (stroke level) and they tried to bring that down. About 10:15 my face was starting to swell and I was short of breath and 10:30 they took me to ER - and gave me Cortisol shot. And IV fluids. And I was in ER for two hours. They wrote me a prescription for six days for 2 prednisone for every day for one week. The PA saw me at the ER and he prescribed. I went home but couldn't drive home because I couldn't see straight so got a ride home. They tested my O2 levels before they left me. Oxygen was 96. My blood pressure was down to 140/95 - so it was down but still elevated. I still had facial swelling for 3 days. But after three or four days it resolved the face swelling. Had a weakness from the shot and still itching but nothing like it was that day still after the four days. Dr. told me I couldn't get second dose. It was an anaphalactic reaction. Dr - prescribed me an EpiPen in case I have another bad reaction to anything.
43 2021-01-19 fast heart rate Systemic: Tachycardia diagnosed by physician
43 2021-01-19 chest discomfort approximately 12 hours after vaccine was administered, patient experienced the following symptoms: s... Read more
approximately 12 hours after vaccine was administered, patient experienced the following symptoms: severe chills and muscle aches; fever of 102.6 that did not respond to Tylenol, headache, vomiting, fatigue, shortness of breath, and chest tightness. She states they lasted for approximately 18 hours, and have started improving in the past 24 hours. Still having symptoms of mild to moderate muscle aches and some shortness of breath. Using albuterol inhaler as needed. Patient is recovering at home currently.
43 2021-01-19 lightheadedness, heart rate increased near syncope w/in 30 min. of vaccine- taken to ER immediately monitored, EKG, and kept for observat... Read more
near syncope w/in 30 min. of vaccine- taken to ER immediately monitored, EKG, and kept for observation increased heart rate, light headed, orthostatic after vaccine continued w/ rapid heart rate, light headed and orthostatic for 3 days day 2 severe body aches, chills, fatigue and headache,, arm pain only at injection site, swollen lymph nodes- Tylenol taken but barely touched pain day 3 still joint aches and headache, fatigue and chills, slight arm pain only at injection site, swollen lymph nodes- Tylenol and rest day 4 felt better, rash began on torso and spread to arms, groin , neck, swollen lymph nodes day 4 rash which began to itch lasting day 4,5,6,7,8- took Benadryl so I could sleep, swollen lymph nodes Continue w/ intermittent chills, body aches, headache and light headed for day s 4,5,6,7,8 Continue w/ swollen lymph nodes under left and right arm and today is day 14
43 2021-01-20 chest pain Chest pain, muscle pain, left arm soreness, fatigue
43 2021-01-21 heart rate increased 20 minutes following vaccine I suddenly experienced tingling in mouth and throat, muscle twitches i... Read more
20 minutes following vaccine I suddenly experienced tingling in mouth and throat, muscle twitches in hands, rapid heartbeat, and rash. I returned to vaccine clinic and was referred to ER. I was observed for several hours and symptoms resolved.
43 2021-01-21 fast heart rate About 40 mins after the injection, I was beyond extremely tired. Extreme body aches, nausea, dizzine... Read more
About 40 mins after the injection, I was beyond extremely tired. Extreme body aches, nausea, dizziness and migraine followed shortly after. I felt to have more of an agitated PVC, PAC and tachycardia activity than usual. This lasted Friday 1/8 through all day Sunday 1/10. On 1/11 I only suffered from the migraine. A very sore arm was only during the first night and alleviated on Saturday afternoon.
43 2021-01-21 chest discomfort Client had vaccine around 5:55pm and was instructed to wait in the lobby for 30 minutes after vaccin... Read more
Client had vaccine around 5:55pm and was instructed to wait in the lobby for 30 minutes after vaccine to monitor for reaction. Around 6:30 pm she went out to her car and came back into the clinic stating that she had pressure in her chest and a lump in her throat. 911 was called and client when to the emergency room where it was determined that she had an allergic reaction to the vaccine. We have called client to follow up but she has not returned our voicemail.
43 2021-01-21 blood pressure increased ELEVATED BP 180 SYS, TINGLING IN FACE , DIZZY, WEAK IN LEGS.
43 2021-01-21 pallor, heart rate increased, chest pain Lightheaded, pale, rapid pulse, chest pain, anxiety, clammy.
43 2021-01-21 pallor Received her second dose of vaccine on 1/12/21 and 2.5 hours later felt shaky, dizzy, nauseated, pal... Read more
Received her second dose of vaccine on 1/12/21 and 2.5 hours later felt shaky, dizzy, nauseated, pale and diaphoretic. Seen in the ED and was given fluids and monitored a couple hours and released. On 1/21/20 she continued to feel poorly with dizziness and ringing in her ears. She was seen by her physician and given a steroid injection and a meclizine prescription. Physician believes her symptoms are a continued reaction to the vaccine.
43 2021-01-22 chest discomfort Patient felt like a belt was tight around her chest from 40 minutes after vaccine and symptoms laste... Read more
Patient felt like a belt was tight around her chest from 40 minutes after vaccine and symptoms lasted for 4 hours. Patient did not feel short of breath or pain, just chest tightness to the point of irritation
43 2021-01-22 palpitations, lightheadedness, chest discomfort Started with mild headache 1/7 night. Near 5am 1/8 had severe rib pain on right, 7am loose stools, m... Read more
Started with mild headache 1/7 night. Near 5am 1/8 had severe rib pain on right, 7am loose stools, midday body aches, chills, finger swelling and joint swelling ha, fvr low grade. I took ibuprophen. By evening add nausea, vomitting, near syncopal event (had to sit quickly b4 passing out), heart palpitations, light headed, chest pressure and just off feeling, fatigue. By 1/9 all same symptoms, 2 more near -syncopal events, rt knee pain, and asthma (I used inhaler x 3 times). Then 1/10 upon waking, I felt amazing and 100% better. During first 3days of symptoms, I slept alot.
43 2021-01-24 fainting, loss of consciousness COVID-19 immunization on 22Dec2020/ COVID-19 immunization on 09Jan2021; Syncopal episode; loss of co... Read more
COVID-19 immunization on 22Dec2020/ COVID-19 immunization on 09Jan2021; Syncopal episode; loss of consciousness; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ek9231) via unspecified route on right arm single dose for COVID-19 immunization on 09Jan2021, 11:00 AM, at 43-year-old. Medical history included: allergies: Cephlasporins; sulfa; clarithromycin (BIAXIN); metronidazole benzoate (FLAGYL). The patient did not have COVID prior vaccination. Concomitant medications in two weeks included: ibuprofen; loratadine, pseudoephedrine sulfate (CLARITIN-D); fluticasone propionate (FLONASE). The patient did not have other vaccine in four weeks. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on right arm for COVID-19 immunization on 22Dec2020, 12:00 PM, at 43-year-old. On 11Jan2021, 12:15AM, the patient had syncopal episode, loss of consciousness for approximate 10 minutes, more than two hours to fully recover. This resulted in emergency room/department or urgent care. Treatment received included: IVFs, sutures. The patient was not tested for COVID post vaccination. Action taken for BNT162B2 was not applicable. Outcome of the events syncope and loss of consciousness was resolved on 11Jan2021, of else event was unknown.; Sender's Comments: Based on the time association, the possible contribution of suspect BNT162B2 to the events syncope and loss of consciousness cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
43 2021-01-24 haemoglobin decreased, palpitations Red blood cells are a little low; Hemoglobin and hematocrit were slightly low; Hemoglobin and hemato... Read more
Red blood cells are a little low; Hemoglobin and hematocrit were slightly low; Hemoglobin and hematocrit were slightly low; fluttering in chest; Rash on left side of face and neck; skin started burning; Anxiety and fear; Anxiety and fear; Racing heart beat; Dizziness/Lightheadedness; Headache; Nausea; Has been on her period for three weeks/Is premenopausal/Was bleeding at time of vaccination; This is a spontaneous report from a contactable Nurse reporting for herself. A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), via an unspecified route of administration at right arm on 06Jan2021 15:22 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital, No agency site. Medical history reported included breast implants, She was healthy and had no medical diagnoses. The patient's concomitant medications was reported as none, She took no medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient wanted to report a possible reaction to the COVID Vaccine. Has been to the ER three times. Had a racing heart beat, dizziness, lightheadedness, and nausea on 08Jan2021. Developed a rash and skin started burning on 11Jan2021. The rash was on the left side of her face and neck. Racing heart beat started first. Then dizziness, headache, lightheadedness, and nausea began. She also had anxiety and fear. All symptoms began on 08Jan2021. Went to the ER on 08Jan2021. Was discharged from the Emergency room. Last night, 11Jan2021, she felt fluttering in chest, but it wasn't as severe as two nights ago. Her EKG was normal. Patient Hoped nothing occurs today. Took three Benadryl last night. Racing heart beat, rash, dizziness, headache, lightheadedness, nausea were all ongoing. The patient was wearing a Halter monitor until 12Jan2021 at 15:00, total duration for Halter monitor is 24 hours. Seriousness: Definitely disabling. Sunday night she thought she might not wake up Monday. She was fearful of all of the weird. Investigations: The patient was advised her labs were ok. Red blood cells are a little low. Hemoglobin and hematocrit were slightly low. Thought hemoglobin was 10.7. EKG was normal, Chest X-Ray was negative. The patient was just trying to figure out why reaction occurred. She Had been on her period for three weeks, was pre-menopausal. Was bleeding at time of vaccination on 06Jan2021. She did have breast implants, and didn't know if that was related or not. The patient Would not be getting the second injection. The nurse assessed the events of Racing heart beat, Anxiety and fear and Rash on left side of face and neck as related. The outcome of the event fluttering in chest was recovering, the outcome of the events Racing heart beat, rash, dizziness/ lightheadedness, headache, and nausea was not recovered and the outcome of the other events was unknown.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events cardiac flutter, palpitations, headache, dizziness and nausea cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
43 2021-01-24 heart rate increased, blood pressure increased, fast heart rate Sensation of fullness in back of throat, progressing to tingling sensation of mouth/face and upper b... Read more
Sensation of fullness in back of throat, progressing to tingling sensation of mouth/face and upper body, and then tachycardia. Became very nervous with the strange sensation and took pulse which was initially in normal range. This however progressed to a rapid heart rate. Overall symptoms lasted 3-4 minutes. Pulled over and exited a busy highway. Called 911 (2:22 pm) during symptoms and they said they could only call an ambulance. Had some confusion when speaking to operator, as I couldn't tell them which exit I was at although I know the exit. Ultimately, drove myself to the hospital parking lot (about 4-5 min away) as heart rate had started to return to normal. Heart rate was in normal range when I rechecked in hospital parking lot. Sat in car for about 5 minutes before deciding to drive back to vaccine clinic to report my symptoms. Clinic about 3-4 minutes away. Pulse ox was normal x 2. BP was actually elevated x 2. Waited 30 minutes before being released home.
43 2021-01-24 palpitations Severe joint pain, hands tingling and then after a few hours they started burning, severe headache, ... Read more
Severe joint pain, hands tingling and then after a few hours they started burning, severe headache, heart racing. These symptoms lasted throughout the night and the next morning the left side of my face was bright red and stayed that way throughout the day.
43 2021-01-25 chest pain As soon as patient received vaccination her left arm became heavy, she became dizzy with chest pain ... Read more
As soon as patient received vaccination her left arm became heavy, she became dizzy with chest pain on deep inspiration. Patient has a PMHx of anxiety which they believe instigated the side effects. Patient was transported via EMS to Palms of Pasadena hospital with non-urgent acuity.
43 2021-01-25 chest pain As soon as patient received vaccination, her left arm became heavy, then she became dizzy with chest... Read more
As soon as patient received vaccination, her left arm became heavy, then she became dizzy with chest pain on deep inspiration. Initially became short of breath, which resolved prior to EMS arrival. EMS transported patient to the emergency room with non-urgent acuity.
43 2021-01-25 chest pain Immediately following vaccination, the patient reported her left arm "becoming heavy", then she beca... Read more
Immediately following vaccination, the patient reported her left arm "becoming heavy", then she became dizzy with chest pain on deep inspiration. EMS transported patient to hospital under non-urgent acuity. Primary impression was generalized anxiety consistent with PMHx of anxiety episodes.
43 2021-01-25 chest discomfort chest tightness, shob, lip tingling, facial edema, peripheral edema, cough - improved w/ 10 mg cetir... Read more
chest tightness, shob, lip tingling, facial edema, peripheral edema, cough - improved w/ 10 mg cetirizine x 1 po vital signs stable
43 2021-01-26 blood pressure increased, heart rate increased 1st 24hrs= Rt (right) side Facial, cheek, jaw, swelling; 1st 24hrs= Rt (right) side Facial, cheek, j... Read more
1st 24hrs= Rt (right) side Facial, cheek, jaw, swelling; 1st 24hrs= Rt (right) side Facial, cheek, jaw, swelling, numbness, tingling. Begin of Rt (right) eye pain, tingling, Rt (right) eye lower lid internal tenderness, softness, sensitivity to touch; 1st 24hrs= Rt (right) side Facial, cheek, jaw, swelling, numbness, tingling. Begin of Rt (right) eye pain, tingling, Rt (right) eye lower lid internal tenderness, softness, sensitivity to touch; 1st 24hrs= Rt (right) side Facial, cheek, jaw, swelling, numbness, tingling. Begin of Rt (right) eye pain, tingling, Rt (right) eye lower lid internal tenderness, softness, sensitivity to touch; 1st 24hrs= Rt (right) side Facial, cheek, jaw, swelling, numbness, tingling. Begin of Rt (right) eye pain, tingling, Rt (right) eye lower lid internal tenderness, softness, sensitivity to touch; 1st 24hrs= Rt (right) side Facial, cheek, jaw, swelling, numbness, tingling. Begin of Rt (right) eye pain, tingling, Rt (right) eye lower lid internal tenderness, softness, sensitivity to touch; eye lower lid internal tenderness; Behind lower Rt (right) ear pain, Rt (right) sided neck pain, Rt (right) side buttocks pain, Rt (right) side thigh pain, swelling, Rt (right) knee pain, and swelling; Behind lower Rt (right) ear pain, Rt (right) sided neck pain, Rt (right) side buttocks pain, Rt (right) side thigh pain, swelling, Rt (right) knee pain, and swelling; Behind lower Rt (right) ear pain, Rt (right) sided neck pain, Rt (right) side buttocks pain, Rt (right) side thigh pain, swelling, Rt (right) knee pain, and swelling; Behind lower Rt (right) ear pain, Rt (right) sided neck pain, Rt (right) side buttocks pain, Rt (right) side thigh pain, swelling, Rt (right) knee pain, and swelling; Behind lower Rt (right) ear pain, Rt (right) sided neck pain, Rt (right) side buttocks pain, Rt (right) side thigh pain, swelling, Rt (right) knee pain, and swelling; Behind lower Rt (right) ear pain, Rt (right) sided neck pain, Rt (right) side buttocks pain, Rt (right) side thigh pain, swelling, Rt (right) knee pain, and swelling; Dizziness; sleepiness; increased blood pressure and pulse; increased blood pressure and pulse; Then sleeplessness till 4am next day; This is a spontaneous report from a contactable Nurse A 43-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), via an unspecified route of administration on 15Jan2021 14:45 at single dose for covid-19 immunisation. Vaccine location was right arm. Medical history included attention deficit hyperactivity disorder from an unknown date, hypothyroidism from an unknown date. The patient's concomitant medications were not reported. The patient previously took cipro [ciprofloxacin] and experienced drug hypersensitivity. The patient experienced 1st 24hrs= Rt (right) side Facial, cheek, jaw, swelling, numbness, tingling. Begin of Rt (right) eye pain, tingling, Rt (right) eye lower lid internal tenderness, softness, sensitivity to touch on 15Jan2021 15:15 with outcome of not recovered, behind lower rt (right) ear pain, rt (right) sided neck pain, rt (right) side buttocks pain, rt (right) side thigh pain, swelling, rt (right) knee pain, and swelling on 15Jan2021 15:15 with outcome of not recovered, dizziness on 15Jan2021 15:15 with outcome of not recovered, sleepiness on 15Jan2021 15:15 with outcome of not recovered, increased blood pressure and pulse on 15Jan2021 15:15 with outcome of not recovered, then sleeplessness till 4am next day (as reported) on 15Jan2021 15:15 with outcome of not recovered. Information on the lot/batch number has been requested.; Sender's Comments: Based on the time association, the possible contribution of suspect BNT162B2 to the events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
43 2021-01-26 nosebleed I had a prolonged nosebleed. i could not get it to stop for 20 minutes, i held my nose, took a showe... Read more
I had a prolonged nosebleed. i could not get it to stop for 20 minutes, i held my nose, took a shower. I have not had a nose bleed in years. I was so strange. Even when i was younger it would typically stop after 1-2 minutes. but this was just a prolonged bleed. I was concerned that my platelets were low and making an appointment to get them checked. As i read information about ITP but i wanted to insert this as a possible vaccine VAERS in case others experiences a similar manifestation after the vaccine
43 2021-01-26 heart rate increased I received my first vaccine on Dec 18. By Dec 25, I had already started with rapid weight loss and a... Read more
I received my first vaccine on Dec 18. By Dec 25, I had already started with rapid weight loss and a feeling of increased energy/metabolism with a fast heart rate. Over the next week, the symptoms escalated and my heartrate was consistently in the range of 95-125. I was losing 2lbs a day without any change in my diet. I lost 12lbs over 2 weeks as I tried to compensate and eat more. I had my thyroid checked with the concern of possible thyroiditis, but my TSH was well within normal limits. My FT3 was on the high end of normal but still within normal limits. Over this time frame, I am also having significant difficulty sleeping and only sleep for 3-5 hours most days. After my second vaccine on Jan 10th, my heartrate and weightloss stabilized and consistently still experiencing a heartrate around 100. I usually weigh around 120 lbs +/- 2 pounds and my weight is now consistently 110 +/- 2 lbs. I am an ER doctor, just for background reference of my medical knowledge. I had the nurse do an ECG on me at work and there were no concerning disruptions in the electrical conduction system of the heart. My blood pressure has been normal throughout, and sometimes rather high up to 160/110. My usual vital signs are BP 110/60 and HR 60-70.
43 2021-01-26 fast heart rate extreme headache; muscle aches; chills; nausea; diarrhea; sweating; tachycardia; This is a spontaneo... Read more
extreme headache; muscle aches; chills; nausea; diarrhea; sweating; tachycardia; This is a spontaneous report from a contactable nurse. This 43-year-old female nurse (patient) reported that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular at left arm on 11Jan2021 06:15 PM at single dose for COVID-19 immunization. Patient was not pregnant. Medical history included anxiety, migraines, palpitations and known allergies: latex, adhesive. Concomitant drugs included paroxetine hydrochloride (PAXIL), alprazolam (XANAX), and unspecified multivitamin. Historical vaccine included the first dose of BNT162B2 on 21Dec2020 06:15 PM via intramuscular at left arm for COVID-19 immunization, and patient had headache and nasal congestion. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. On 11Jan2021 09:45 PM, patient experienced extreme headache, muscle aches, chills, nausea, diarrhea, sweating, tachycardia. No treatment was received. Outcome of events was unknown. Information on the lot/batch number has been requested.
43 2021-01-26 palpitations hot sensation/weird very hot rush down her right arm that was vaccinated and went up the back of her... Read more
hot sensation/weird very hot rush down her right arm that was vaccinated and went up the back of her neck only on the right side; dizzy; Heart racing; Her arm was very sore- it was difficult to lift it; Her arm was very sore- it was difficult to lift it; She did feel a little out of it, as it produced a little bit of anxiety; A mild allergic reaction; This is a spontaneous report from a contactable Other Health Professional (patient). A 43 years old female patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL3248, Expiration Date: Apr2021), via an unspecified route of administration on 12Jan2021 at 13:22 at single dose on right arm for covid-19 immunisation. Medical history included vasovagal (she did have a history of vasovagal. She talked to her doctor about this prior to the vaccine. At first when she had it her previous doctor felt a little confused. She was unsure if it was vasovagal or a blood clot in her lungs. She did get it checked out with a cat scan and there was no clot. They had to have tested her for anaphylaxis at that time. It was not a clear diagnose. Then she saw a cardiologist. She was diagnosed with vasovagal at that time. It lasted only a few months and she was fully recovered). Concomitant medications included ongoing ergocalciferol (VIT D) and ongoing vitamins NOS (MULTIVITAMIN). Patient received the vaccine on Tuesday, 12Jan2021. Her appointment was at 12:54, but she got the vaccine at 13:22. She was looking at her phone to re-schedule her second dose. She felt totally fine. At 13:27 she had this weird very hot rush down her right arm that was vaccinated and went up the back of her neck only on the right side. She looked up from her phone and was very dizzy. She stood up and as she did her heart started to race. It was a really weird feeling that she has never felt. She was a little out of it. She had no trouble breathing. Within 30 seconds she was completely fine. She did feel a little out of it, as it produced a little bit of anxiety. She had no other symptoms. She stayed at the facility for 30 minutes. As she was leaving one person asked how she felt and she was told to let the EMTs know. She let them know what happened. One woman working there said it could have been an anxiety attack. She did not have a lot of anxiety but she did have some. It did not feel like that. She had never had the warm sensations or heart racing. She was totally fine when talking to the EMTs. They did not seem concerned and they let her schedule her second shot. She read on Pfizer about allergic reactions. She was assuming this was what happened. A mild allergic reaction. She had no breathing issues or hives. Her arm was very sore- it was difficult to lift it. She had also never had this type of soreness with vaccines. Dizziness: She has had the dizziness a couple of times. Twice now. One when she had gotten home. It was very mild and nothing compared to what she had when she got the vaccine. Then another last night at bedtime. It was a woosh of dizziness. Arm soreness: very improved now. felt like she would normally have after getting a vaccine. The first day was intense but after a few hours was less. The next day she woke up and it was pretty much gone. She still had a little but it has mostly improved. Caller stated she would still like to get the second dose but she was a little nervous. She had it maybe once or twice since then and it has been mild with no extreme pressure drops. They thought maybe it was a virus that affected her. Her reaction to the vaccine was different. The difference was pretty significant. Vasovagal felt like her heart will stop and she will pass out. After the vaccine she felt dizzy but didn't feel faint, and had a racing heart. Nobody seemed concerned about her reaction and getting the second dose. But she read that Pfizer does not recommend getting the second dose even if you had a mild reaction. She was wondering what she should do. Her second dose is scheduled for 02Feb2021. Outcome of hot sensation/weird very hot rush down her right arm that was vaccinated and went up the back of her neck only on the right side and heart racing was resolved on 12Jan2021, dizzy was resolved on 13Jan2021, outcome of anxiety was unknown, outcome of her arm was very sore- it was difficult to lift it and a mild allergic reaction was resolving.
43 2021-01-27 palpitations, fast heart rate, hypertension Dizzy, palpitations, tachycardia, high blood pressure
43 2021-01-27 chest pain intermittent sharp pain in left arm, chest and shoulder blade; intermittent sharp pain in left arm, ... Read more
intermittent sharp pain in left arm, chest and shoulder blade; intermittent sharp pain in left arm, chest and shoulder blade; intermittent sharp pain in left arm, chest and shoulder blade; redness in face and eyes; redness in face and eyes; feels warm; This is a spontaneous report from a contactable consumer (patient is girlfriend). A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EKH176), via an unspecified route of administration on 12Jan2021 morning at single dose for covid-19 immunization. Vaccine location was left arm and it was the second dose. Patient received the first dose of vaccine on unspecified date for covid-19 immunization. The patient medical history was none. There were no concomitant medications. The patient was currently having side effects, stated she was having on and off, intermittent, sharp pain in her left arm, left chest and left shoulder blade, feeling the pain all on her left side on 13Jan2021. The reporter stated the patient looked worse than she did 2 hours ago, that her face was turning red and her eyes were turning red and she felt a little warm on 12Jan2021. The reporter wants to know when she should take the patient to the hospital. The reporter was encouraged to reach out to a health care provider. The outcome of events was not recovered.
43 2021-01-28 chest discomfort, chest pain Next day fever 100.8 and chills. 2 days later very bad headaches that lasted until 1/23. ER visit ... Read more
Next day fever 100.8 and chills. 2 days later very bad headaches that lasted until 1/23. ER visit on 1/21 for chest pressure, lightheadedness, dizzy. Cardiac work up- negative. Discharged. Still lightheaded and dizzy 1/22 - 1/24. On 1/25 sharp chest pains went to see my PCP. She prescribed a steroid pack. 1/26 at 3:30 pm felt weak, felt like I was going to black out. Went back to the ER- full cardiac work up, head CT, admitted to the hospital for observation. Stress test on 1/27. Everything normal. Follow up with PCP on 1/29 still very lightheaded. Ordered a 48 hour heart monitor and Neurology consult.
43 2021-01-28 chest pain Starting on the 18th I started having pain and numbness in my limbs and chest. I ended up going to t... Read more
Starting on the 18th I started having pain and numbness in my limbs and chest. I ended up going to the ER where they tested me for Covid and checked my heart. Everything came back negative. The next day I started having severe muscle weakness to where I couldn't stand for more than 5 or 10 mins without feeling like I was going to fall over. I couldn't hold anything up for long without my arms giving out. I started having muscle twitching all over including in my face. I would also have what I would describe as electrical shock nerve pain all over. I went to the ER again and everything came back okay again. I went to Urgent Care and my MD. My doctor stated after looking at the results from the ER that it was related to the vaccine. I was put on high doses of vitamins to see if it would help my body fight the reaction to the vaccine. I was taken out of work for the week because I literally couldn't do anything. I took the vitamins for 5 days before I started finally feeling better. I'm okay now for the most part. I still am having muscle twitching and nerve pain, but it is far more tolerable than it was.
43 2021-01-29 chest discomfort Muscles twitches in different parts of the body, started in left arm and have been ongoing. Frequenc... Read more
Muscles twitches in different parts of the body, started in left arm and have been ongoing. Frequency has gone down since the injection. Tremors (chest feels like it is shaking/pulsating) - this started about 10 days after the injection
43 2021-01-29 chest pain cellulitis in arm given an antibiotic and a steroid right arm is swollen red and hot cause pain to ... Read more
cellulitis in arm given an antibiotic and a steroid right arm is swollen red and hot cause pain to chest back and i developed a lump in a armpit
43 2021-01-31 chest discomfort 01/29/2021 930 noticed an itch on left thigh, like I wanted to hive - on various spots throughout t... Read more
01/29/2021 930 noticed an itch on left thigh, like I wanted to hive - on various spots throughout the day. 01/30/2021 very tired (to be expected), noticed I had burning in what feels like my gall bladder and developed an ?odd? stomach ache later in the day. Thought it had to do with something I ate, but consumed nothing out of the ordinary. Went to bed early, felt like I wanted to fever but never did. decided to take a tsp of children?s Allegra because I still felt ? itchy? at times. 01/31/2021 woke up to what felt like pressure on my chest, like someone was squeezing me. Thought that was odd and thought it was perhaps the way I slept. Was still tired (4AM) went back to sleep. Woke up again feeling more rested and the same feeling. It was an awful feeling. Grabbed my pulse oximeter and my oxygen was about 96 laying down. Called an. ER, thought maybe I had Covid or something as I have never felt that way before. Receptionist told me she felt the same way after she got the shot. I ate, felt better but then developed a horrific headache akin to a migraine that was so sensitive to any movement I made. Felt like someone was shaking my head, it was so painful and I became disoriented. Like. I would get confused in my thoughts. Became very sensitive to light and movement. Looking at Facebook, I had to stop because I felt like I was going to seizure. Had to really rest. Ate lunch and took a multivitamin to see if that helped. Eventually I felt better but had to be careful, take it easy. 02/01/2021 woke up this morning still tired, like my body is fighting something. And I could fell the headache coming on and noticed I was getting confused in my thoughts. I decided to stay home from work. The morning was very bad as I felt as though I wanted to seizure. Could not get a hold of my doctor. My head still hurts, not as bad, but after I eat, I get confused and can?t hold two thoughts at once if that makes sense. Head seems very sensitive to eye movement like yesterday. It?s a gross feeling, even in absence of the pain.
43 2021-01-31 chest discomfort dizziness, woozy feeling, lightheaded; Pressure in chest; Feeling of heat across body; Frontal lobe ... Read more
dizziness, woozy feeling, lightheaded; Pressure in chest; Feeling of heat across body; Frontal lobe headache; This is a spontaneous report from a contactable other HCP (patient). A 43-year-old female patient (Not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration at right arm on 18Jan2021 10:45 at single dose for covid-19 immunization. Medical history included hypothyroidism, asthma, known allergies: penicillin and sulfa, bee stings. Concomitant medication in two weeks included salbutamol (ALBUTEROL), levothyroxine, liothyronine (NP THYROID). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced dizziness, woozy feeling, lightheaded, pressure in chest, feeling of heat across body, frontal lobe headache on 18Jan2021 at time of 11:30 am. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was unknown. Information on the Lot/Batch number has been requested.
43 2021-02-01 heart rate increased, hypertension Racing pulse and High blood pressure
43 2021-02-02 heart rate increased, hypertension, blood pressure increased felt numbness in mouth; felt numbness in mouth. It spread to arms and hands; Eexperienced muscle twi... Read more
felt numbness in mouth; felt numbness in mouth. It spread to arms and hands; Eexperienced muscle twitching in hands; feel dizzy; A light rash covered my chest and arms; My heart rate and blood pressure were elevated; My heart rate and blood pressure were elevated; This is a spontaneous report from a contactable Other Health Professional reported for herself. A 43-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Jan2021 19:45 for covid-19 immunization, via Left arm in hospital. Medical history included arthritis from an unknown date and unknown if ongoing. She had no allergies to medications, food, or other products. Concomitant medication included probiotics (PROBIOTICS) and Multivitamins. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. 20 minutes following injection, the patient experienced felt numbness in mouth, felt numbness in mouth, it spread to arms and hands. She went to ER (Emergency room/department or urgent care) and started to feel dizzy and experienced muscle twitching in hands, a light rash covered her chest and arms, heart rate and blood pressure elevated, all on 19Jan2021 20:15 with outcome of recovering. She had no history of these symptoms and was in good health. The action taken in response to the event(s) for bnt162b2 was not applicable. She received Benadryl as a result of events.; Sender's Comments: The reported events were causally related to the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), due to plausible temporal relationship and clinical course. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
43 2021-02-03 blood pressure increased Very dizzy, light headed, did not feel good felt unbalance like a motion sickness , headaches, ringi... Read more
Very dizzy, light headed, did not feel good felt unbalance like a motion sickness , headaches, ringing in ear, and nausea. Blood pressure was elevated.
43 2021-02-03 chest discomfort, fast heart rate Within 2 mins of shot: Tachycardia, dizziness, some mild shortness of breath/chest tightening, redd... Read more
Within 2 mins of shot: Tachycardia, dizziness, some mild shortness of breath/chest tightening, reddening of face/chest (and strange almost metallic taste in mouth). The metallic taste subsided quickly (within 2 mins) tachycardia subsided quickly (within 5-10min), and I felt dizzy for approx 30mins (the skin on my chest still looks slightly red approx 2 hours later). The next day/morning I awoke with slightly puffy/swollen face and upper lip lightly swollen/tingly
43 2021-02-03 chest pain fever 99.1 Fahrenheit; shivers and chills; shivers and chills; body aches; Headache; dull chest pain... Read more
fever 99.1 Fahrenheit; shivers and chills; shivers and chills; body aches; Headache; dull chest pain; Fatigue; Injection site pain; This is a spontaneous report from a contactable consumer, the patient. A 43-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EK4176), via an unspecified route of administration, in the left arm on 15Jan2021 at 08:50 AM (at the age of 43-year-old) as a single dose for COVID-19 immunization. Medical history was none. There were no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination On 15Jan2021, the patient experienced injection site pain. On 18Jan2021, the patient experienced fever 99.1 Fahrenheit, shivers and chills, body aches, headache, dull chest pain, fatigue,. The patient had lab tests which included: 18Jan2021: pyrexia: 99.1 Fahrenheit, 19Jan2021: pyrexia: 98.9 Fahrenheit. Treatment for the body aches included with Theraflu, and ibuprofen liquids for the headache. The clinical outcome of the event injection site pain was recovered on 16Jan2021, fever 99.1 Fahrenheit, and dull chest pain was recovered on 19Jan2021, shivers and chills was recovered on 20Jan2021. The clinical outcome of the body aches, headache, fatigue, was not recovered. It was also reported that since the vaccination, the patient had been tested for COVID-19 on 19Jan2021, the results of which was negative.
43 2021-02-04 excessive bleeding I was approximately 4 weeks pregnant at the time that I received dose #1 (12/23/20)- I was unaware o... Read more
I was approximately 4 weeks pregnant at the time that I received dose #1 (12/23/20)- I was unaware of the pregnancy. I was diagnosed with COVID on 12/28/20, but was first symptomatic on 12/24. I attributed my s/s initially to the vaccine. I was eventually tested on 12/28/20, as my symptoms worsened and I was positive for COVID. On 1/14/21 I received my second dose, my COVID s/s had been resolved since 1/4/21. On the evening of 1/18/21 I started experiencing mild abdominal pain. This progressed, on the evening 1/20 the pain was no longer tolerable. I went to the ER where I hemorrhaged and needed emergency surgery and a blood transfusion for a miscarriage. The surgery ultimately took place in the early morning hours of 1/22/21, followed by the blood transfusion.
43 2021-02-05 heart rate increased RAPID HEART RATE
43 2021-02-07 blood pressure increased Three min after vaccine, pt started feeling SOB racing heart. BP 148/100, HR 80, SPO2 100% RA, T:9... Read more
Three min after vaccine, pt started feeling SOB racing heart. BP 148/100, HR 80, SPO2 100% RA, T:97 Six minutes after: dose, lethargic, sleepy, eyes dropped (look tired) & dizzy & c/o anxiety. Friend P/U to take her to ER. BP 144/92
43 2021-02-09 hypertension Hypertension; Dizziness; Blurred vision; This is a spontaneous report from a contactable pharmacist.... Read more
Hypertension; Dizziness; Blurred vision; This is a spontaneous report from a contactable pharmacist. A 43-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), intramuscular on 25Jan2021 11:00 at single dose for covid-19 immunisation. Medical history included hypertension and Hypertension, allergies to peanuts. Concomitant medication included amlodipine, estradiol. The patient experienced Patient experienced Hypertension (BP 140/103), dizziness and blurred vision immediately after vaccine administration. All AE's resolved within 2 hours with dizziness and blurred vision resolving first (HTN took longer to resolve) on 25Jan2021 11:00. Outcome of events was recovered.
43 2021-02-21 chest discomfort Patient reported light headedness and cough 45 min after injection. with rest and oral fluids. res... Read more
Patient reported light headedness and cough 45 min after injection. with rest and oral fluids. resolved. over the next few days. patient reported increased fatigue and SOB. advised patient to seek medical attention for symptoms which she did today. reports she has now left sided chest discomfort. and left arm pain.
43 2021-02-22 blood pressure decreased Began feeling itchy in the roof of mouth. Began coughing. Felt like her blood pressure was dropping.... Read more
Began feeling itchy in the roof of mouth. Began coughing. Felt like her blood pressure was dropping. Received 20 mg IV Famotidine, 10 mg IV Dexamethasone, 0.3 ml sub Q Epinephrine, 25 PO Benadryl and 1 liter Normal Saline. RN documents that blood pressure did drop to 107/64, but did not become hypotensive. Discharged in stable condition at 1500. Doctor recommended that she not receive second dose.
43 2021-02-22 palpitations pt initially noted palpitations and shortness of breath. After several minutes improved and then pt ... Read more
pt initially noted palpitations and shortness of breath. After several minutes improved and then pt developed lip and tongue swelling
43 2021-02-23 fast heart rate "Received 2nd Covid vaccination have had headaches, earaches, tachycardia, and SOB since vaccination... Read more
"Received 2nd Covid vaccination have had headaches, earaches, tachycardia, and SOB since vaccination" TM was hospitalized 3xs after vaccination. On 1/24/21 TM was hospitalized and kept overnight for tachycardia and SOB and has to f/u with cardiology this week. The second time TM went to the hospital for a headache where an MRI was done. The third time she was also treated for a headache
43 2021-02-23 fast heart rate, chest discomfort Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: A... Read more
Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: epipen was administered at 1:02 PM by, benadryl 50 mg po, and O2 inhalation, and patient was transported to ED at 1:08 PM. patient was given a second dose of epipen in the ambulance and at 2:48 PM, patient is stable and improving-Severe, Systemic: Shakiness-Severe, Systemic: Tachycardia-Severe, Systemic: Weakness-Severe, Additional Details: at 12:20 PM, recieved the pfizer bointech covid vaccine- 1st dose. lot:el9269 exp:05/21 which was mixed by employee and injected by employee. prior to getting the vaccine, patient told employee that she recueves cortisone injections in her elbow, unknown frequency, and due for her next injection on the following day 02-24-2021 and employee told her that she can double check with her doctor and consented to recieving the vaccine. at 12:30 PM
43 2021-02-23 chest discomfort Systemic: Allergic: Anaphylaxis-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe
43 2021-02-24 hypotension A 43 y.o. female received her first dose of the COVID 19 vaccination. She was given the Pfizer vacc... Read more
A 43 y.o. female received her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the right deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience lightheadedness and feeling weak. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , hypotension, rapid progression of symptoms, respiratory distress, skin changes and tongue swelling. PMH: anxiety and bipolar. Takes Aripiprazole for this. No other medical history reported. ALLERGY REVIEW OF SYSTEMS: Patient complains of dizziness (lightheaded), Patient denies chills, fever, malaise/fatigue, facial swelling, sore throat, frequent throat clearing, eyes itching, cough, chest tightness, shortness of breath, wheezing, rash, hives, eczema, cysts, itching of skin, abdominal pain, joint pain and headaches. Previous Reactions: none. Vitals -- 02/19/21 0350 02/19/21 1610. BP: 131/77 125/77. Pulse: 89 75. Resp: (!) 22 16. SpO2: 100% 100% Physical Exam--Vitals and nursing note reviewed. Constitutional -- General: She is not in acute distress. Appearance -- Normal appearance. She is well-developed. She is not ill-appearing, toxic-appearing or diaphoretic. HENT: Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. Comments: Clear oral airway/intact Eyes: Conjunctiva/sclera: Conjunctivae normal. Neck: Thyroid: No thyromegaly. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing. Musculoskeletal -- Cervical back: Neck supple. Skin -- General: Skin is warm and dry. Capillary Refill: Capillary refill takes less than 2 seconds. Neurological -- General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time; Gait: Gait normal. Psychiatric -- Mood and Affect: Mood is anxious; Behavior: Behavior normal; Thought Content: Thought content normal; Judgment: Judgment normal. Assessment/Plan -- Treatment included: water and snacks. Follow up response to treatment: good. Patient discharge: Stable to go home and follow up with PCP; Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health). Pt aware of monitoring symptoms at home. Follow up as needed with pcp. Recommend that she eat a snack and hydrate prior to next vaccine #2 of Pfizer.
43 2021-02-24 fast heart rate, chest discomfort, chest pain Pfizer COVID-19 Vaccine EUA Pt received 2nd dose of COVID vaccine 1/15/21. A few hours after receiv... Read more
Pfizer COVID-19 Vaccine EUA Pt received 2nd dose of COVID vaccine 1/15/21. A few hours after receiving vaccine, pt developed shoulder and neck pain. She felt feverish, chills that night but did not check temperature. Over next few days, she developed increasing generalized body aches, joint aches, headaches, weakness, fatigue. On 1/21/21 pt noted SOB and chest tightness, so she reported to ED. She checked her pulse ox and was 99%, was tachycardic to 140-150. She takes propranolol for essential tremor, so she took propranolol 40 mg PO x 1 and presented to ED on 1/21/21. In ED, pt was no longer tachycardic. Pt also states her concern for blood clot (mother had DVT in her 30s). She presented with moderate chest pain and tightness, as well as headache, weakness, SOB. Pt given APAP 1000 mg PO x 1, ibuprofen 800 mg PO x 1, orphenadrine 100 mg PO x 1. Nitroglycerin 0.4 mg SL x 1 ordered, but not given on MD's orders. Pt discharged home. 1/22/21: Pt f/u with hospital. DO says her elevated WBX and Cr were likely d/t vaccine and dehydration. DO offered to schedule f/u BMP and CBC on Monday 1/25. Pt also scheduled for outpt fluids at infusion center on Monday 1/25 in case BMP and CBC still indicate dehydration.
43 2021-02-25 chest pain Neck/back chest pain; Neck/back chest pain; Neck/back chest pain; dizzy; weak; fever; This is a spon... Read more
Neck/back chest pain; Neck/back chest pain; Neck/back chest pain; dizzy; weak; fever; This is a spontaneous report from a contactable nurse (the patient). This 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL9262), dose 2, single dose via an unspecified route of administration in the left arm on 26Jan2021 at 10:00 AM (at the age of 43- years-old) for COVID-19 vaccination. The patient's medical history included hypertension, hyperlidemia, pre-cancer cells in cervix, hysterectomy and allergy to penicillin. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: ELO1423, expiration: 1/2021), single dose, dose 1 in the right arm on 05Jan2021 at 10:00 AM. Concomitant medications included atorvastatin, hydrochlorothiazide, losartan potassium (LOSARTAN/HCTZ), fluoxetine (PROZAC) and zolpidem (AMBIEN). On 27Jan2021, the patient had neck, back and chest pain, dizzy, weak and fever. The events were reported as non-serious. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. No therapeutic measures were taken as a result of neck, back and chest pain, dizzy, weak and fever. The clinical outcome of neck, back and chest pain, dizzy, weak and fever was not recovered . The patient has been tested for COVID-19 since having the vaccine. On 25Jan2021, COVID rapid test was negative.
43 2021-02-28 fast heart rate 10 minutes after vaccine pt developed sob, tachycardia, vomiting - taken to ED
43 2021-02-28 lightheadedness she may have been panicked; she already has a pre-existing cardiac arrhythmia, but it seemed to have... Read more
she may have been panicked; she already has a pre-existing cardiac arrhythmia, but it seemed to have gotten worse after receiving the 1st dose/More arrhythmia problems; she already has a pre-existing cardiac arrhythmia, but it seemed to have gotten worse after receiving the 1st dose/More arrhythmia problems; left arm soreness; she felt ugh, like she was getting sick; sensation like she was going to pass out; Headache; This is a spontaneous report from a contactable nurse (patient). This 43-year-old female patient female received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EM9810, intramuscular on left deltoid on 04Feb2021 as single dose (at the age of 43 years) for Covid-19 Immunization. No medical history reported, and no concomitant medication reported. Historical vaccine included BNT162B2 for Covid-19 Immunization. Medical history included Pacemaker in Jun2019 and ongoing, sick sinus syndrome, and pre-existing cardiac arrhythmia ongoing. Historical vaccine included Tetanus, Tetanus made her arm sore, the soreness from tetanus was worse than the soreness from COVID vaccine since it lasted a week with tetanus, no lot number reported. No concomitant medication was reported. The patient experienced she already has a pre-existing cardiac arrhythmia, but it seemed to have gotten worse after receiving the 1st dose/More arrhythmia problems on 05Feb2021 considered medically significant with outcome of not recovered, Within 15 minutes after receiving the vaccine she felt like she was going to pass out three times on 04Feb2021 considered medically significant and recovered on 04Feb2021, she may have been panicked on unspecified date with outcome of unknown, left arm soreness on 05Feb2021 with outcome of recovered on Feb2021, and she felt ugh, like she was getting sick on 05Feb2021 with outcome of unknown. The patient did not receive treatment for events. She stayed an extra 30 minutes to be monitored after the initial waiting of 15 minutes since she had to drive home, then she felt better. She has not called her cardiologist since she has the history of arrhythmias. She had the more arrhythmias start on the evening of the 05Feb2021, states it was weird because it seems to happen more in the evening between 6 and 9pm, sometimes as late as 10pm. However, 'yesterday' it started happening during the day, and it is more frequent, not constant, it just happens. States it is hard not think about it when her heart is having hiccups since that is what it feels like. She knows what it feels like because when her pacemaker goes off ventricularly she can feel it. She had arrhythmias before the vaccine but has not had issues with arrhythmias continuously. She was diagnosed with sick sinus syndrome and they do not know if it is cardiology or neurology, states it has been an issue for her for the last two years (2019). Lab data included weight of 284-286. She is asking if there is any data that supports her getting the second dose on 25Feb2021. She has read that some people tend to have more side effects with the second dose. The patient had no prior vaccinations (within 4 weeks).; Sender's Comments: Based on vaccine-event chronological association, a causal relationship between events worsening arrhythmia and pre-syncope and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
43 2021-03-01 heart rate increased heart rate jumped up; thought she was going to pass out; eyes were blurry; This is a spontaneous rep... Read more
heart rate jumped up; thought she was going to pass out; eyes were blurry; This is a spontaneous report from a contactable consumer. A 43-year-old female consumer received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9264) on 10Feb2021 at single dose via an unspecified route of administration on left arm for COVID-19 immunization. Relevant medical history included autoimmune issues diagnosed in 2006-2007. Concomitant medications were not reported. After 4 days from vaccination on 14Feb2021 the patient experienced blurred vision, increased heart rate, and feeling that she will pass out (as such) . She went to the Emergency Room and they did two EKGs, two COVID tests, and blood work to check the enzymes in her blood for her cardiac muscle, but there was no reason, nothing they could find about why her heart rate spiked. Patient also reported that her heart rate went up from about 03:00PM up thru midnight last night, and was still not down completely, it was a little erratic, but it was better than it was. She was prescribed treatment at the hospital to bring her heart rate down, but they didn't want to give her more and risk lowering her blood pressure. Patient was monitored through the night, and she was supposed to see a cardiologist there but they didn't show up, so she put a phone call in to hers. She was admitted to the hospital overnight. The patient recovered from the events on an unspecified date.
43 2021-03-03 blood pressure decreased, heart rate increased, chest discomfort 10 min after it felt like blood pressure dropped, quickly and sharp like if I had dropped from a tal... Read more
10 min after it felt like blood pressure dropped, quickly and sharp like if I had dropped from a tall building, then quick pulses, and then I felt my lungs were full/heavy.
43 2021-03-03 chest discomfort, fast heart rate Patient became significantly SOB w/ increasing coughing and chest tightness. Patient also developed... Read more
Patient became significantly SOB w/ increasing coughing and chest tightness. Patient also developed lightheadedness. She was transferred to a litter and had a pulse ox applied. She noted increased SOB after lying flat and was administered an Epi-pen and then placed in an upright seated position (supported). Symptoms did improve and she was also administered 4 puffs of her personal inhaler with additional improvement but not complete resolution. EMS was contacted and patient was evacuated to the ER for further evaluation and treatment. HR remained tachycardic and SPO2 98%.
43 2021-03-04 chest pain 11th in the evening, I suddenly had gastric pain in Stomach and was belching a lot. Then it started ... Read more
11th in the evening, I suddenly had gastric pain in Stomach and was belching a lot. Then it started hurting with a lot of chest pain. The pain started going behind my back and pressure and we went to ER and when I went to take my urine test and I threw up a lot. I felt pretty good after that. My reports from tests came back okay. They told me to take over the counter Prilosec and gave a prescription for Zofran.
43 2021-03-04 heart rate increased Pt c/o fast heart beat reported to EMT at 1445. EMT assessed pt. HR: 68, BP: 140/84. Pt denies chest... Read more
Pt c/o fast heart beat reported to EMT at 1445. EMT assessed pt. HR: 68, BP: 140/84. Pt denies chest pain, unlabored breathing. Pt reports no allergies to vaccines, denies throat irritation, denies nausea. Pt escorted by EMT outside at 1455. Pt advised to wait an extra 15 minutes. Pt symptoms resolved. Pt left facility at 1530 with her son.
43 2021-03-09 chest pain Fatigue swelling of face Shortness of breath Cough Joint pain Headache Chest pain dizziness
43 2021-03-14 deep vein blood clot, pulmonary embolism, fibrin d dimer increased Starting on February 24, 2021, I started to have shortness of breath. This slowly got worse until on... Read more
Starting on February 24, 2021, I started to have shortness of breath. This slowly got worse until on March 2, 2021 I was unable to breathe in all the way and was getting a sharp pain in my side/back when I tried to breathe in more than half way. I then went to the emergency room recognizing the symptom as likely being a pulmonary embolism, as I had experienced one four years earlier. It was, in fact, a PE. I was in the hospital for five days as they treated the clots with blood thinners. I slowly got my breathing more back to normal and was discharged. They are still runnying myriad tests to try to determine the cause or causes, but I thought it wise to report here in case the vaccine is a factor. I received my second dose on 2/26/21, a few days before I went to the hospital but my symptoms started a few days before that.
43 2021-03-14 palpitations sweating; palpitations; severe dizziness; This is a spontaneous report from a contactable other heal... Read more
sweating; palpitations; severe dizziness; This is a spontaneous report from a contactable other health professional (patient). A 43-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on Left arm on 01Feb2021 13:45 at single dose for covid-19 immunisation. Medical history included none. The patient's concomitant medications were not reported. On 03Feb2021 07:30, patient had sweating, palpitations, severe dizziness. The patient not received treatment for the event. the patient not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient diagnosed with COVID-19 was unknown; Since the vaccination, the patient not been tested for COVID-19.The seriousness was reported as non-serious. The outcome of the events unknown. Information on the lot/batch number has been requested.
43 2021-03-24 fainting Guillain Barre Syndrome; POTS; Syncope; This is a spontaneous report from a contactable other hcp. A... Read more
Guillain Barre Syndrome; POTS; Syncope; This is a spontaneous report from a contactable other hcp. A 43-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 23Dec2020 07:30 (Batch/Lot Number: EH9899) as SINGLE DOSE for covid-19 immunisation. Medical history included Known allergies as wine. Concomitant medication included loratadine (CLARITIN [LORATADINE]) 10 mg, as needed, daily for unspecified indication. On 23Dec2020 07:45 patient experienced Paresthesia tip of RIGHT little finger within 10 minutes of vaccine. Tachy arrhythmia, loss of function in RIGHT little finger/hand, and syncope 45 minutes after vaccine while driving. Tachycardia, hypertension, generalized weakness, and severe fatigue walking upstairs (persistent and worsened over several days). Loss of function/sensation RIGHT arm and RIGHT leg 8 days after vaccination. Symptoms persisted and worsened. Diagnosed with Guillain Barre Syndrome and POTS at follow up on 19Jan2021. She still have persistent weakness/paresthesias/neuropathy. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 31Dec2020. Seriousness criteria for all events was hospitalization.The events Guillan Barre syndrome and syncope were medically significant. Outcome of the event Guillain Barre Syndrome was recovering. Outcome of the other events was unknown.
43 2021-03-24 chest pain, heart rate increased Itching; Burning in my throat and chest and arm; Burning in my throat and chest and arm; Throat swel... Read more
Itching; Burning in my throat and chest and arm; Burning in my throat and chest and arm; Throat swelling; Chest pain/burning in her throat and chest; Rapid heart beat; This is a spontaneous report from a contactable consumer (patient). This 43-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in left arm on 16Mar2021 at 02:00 PM at single dose (lot number: EN6208, expiration date: 30Jun2021) for COVID-19 immunization. Medical history included known allergies to 32 meds and nuts and shellfish, asthma, COPD and seizures and chronic lung disease. Concomitant medications included prednisone and topiramate (TOPAMAX) in two weeks. The patient had no other vaccine in four weeks. The patient was not pregnant when vaccination. The patient was given the covid 19 shot and within mins. The patient tested the shot and started to have itching and burning in her throat and chest and arm and given 50 mgs of Benadryl in her inhaler then a hour later had to go to ER due her throat swelling closed and chest pain, rapid heart beat was given Benadryl n Prednisone. Events started from 16Mar2021 02:15 PM. AE resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, life threatening illness (immediate risk of death from the event). The patient was recovered with lasting effects. Treatment was received for AE at ER 50 mgs Benadryl and 60 mgs of Prednisone. The patient had no Covid prior vaccination, no Covid tested post vaccination. Outcome of all events was recovered with sequel. Seriousness criteria was reported as life-threatening.
43 2021-04-11 fast heart rate, hypertension Anaphylaxis, acute respiratory distress, mild tongue edema
43 2021-04-24 excessive bleeding bleeding; have not had a period in four years, five days after my second shot and I am having terrib... Read more
bleeding; have not had a period in four years, five days after my second shot and I am having terrible menstrual pain and bleeding; have not had a period in four years, five days after my second shot and I am having terrible menstrual pain and bleeding; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 43-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Formulation: Solution for injection) via unspecified route of administration on arm left at a SINGLE DOSE on 06Apr2021 15:15 for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Formulation: Solution for injection) via unspecified route of administration as a SINGLE DOSE on 16Mar2021 14:15 for COVID-19 immunization. The patient had no relevant medical history. Patient received other medications in two weeks are Lisinopril and LEVONORGESTREL (mirena). On 10Apr2021 patient use an iud for birth control and have not had a period in four years, five days after my second shot and I am having terrible menstrual pain and bleeding. Patient didn't received treatment for the events. The clinical outcome of the events not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
43 2021-04-28 fainting, heart rate decreased Fainted; fell down to the ground after using restroom; I was cold; sweating; slowed heartbeat and pu... Read more
Fainted; fell down to the ground after using restroom; I was cold; sweating; slowed heartbeat and pulse; extreme nausea; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine), dose 1 via an unspecified route of administration, administered in Arm Right on 15Apr2021 14:00 (Batch/Lot number was not reported), at the age of 43 years, as single dose for covid-19 immunization. Medical history included fibromyalgia and t5 back fracture. The patient is not pregnant. Concomitant medications included pregabalin (LYRICA); buspirone and cannabidiol (CBD OIL). On 16Apr2021 at 2 AM, the patient fainted 12 hours later and fell down to the ground after using restroom. She was cold, sweating, slowed heartbeat and pulse, extreme nausea. The patient did not receive treatment for the events. The patient had No COVID-19 prior to vaccination and had not been COVID-19 tested post vaccination. The outcome of the events fainted, fell down to the ground after using restroom, she was cold, sweating, slowed heartbeat and pulse, extreme nausea was unknown. Information about lot/batch number has been requested.
43 2021-04-28 palpitations, loss of consciousness almost passing out; Racing heart; tingling hands; dizziness; This is a spontaneous report from a con... Read more
almost passing out; Racing heart; tingling hands; dizziness; This is a spontaneous report from a contactable consumer (patient). A 43-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 15Apr2021 (Batch/Lot number was not reported) (age at vaccination: 43-years-old) as SINGLE DOSE for covid-19 immunisation. Medical history included hypothyroidism, and allergies: Penicillin. Concomitant medication included levothyroxine. No other vaccine in four weeks. No COVID prior vaccination. No COVID tested post vaccination. The patient was not pregnant. The patient experienced racing heart, tingling hands, almost passing out, dizziness. She was driving so she pulled over and called(#). Symptoms improved enough so that she did not request an ambulance. 10 minutes later she was home and became lightheaded again which has not resolved. It has been 1.5 hours since her dose. Adverse events started on 15Apr2021. No treatment received for the events. The outcome of events was recovering. Information on the lot/batch number has been requested.
44 2020-12-31 fibrin d dimer increased Pleuritic chest pain, seen in ED, 12/31/2020, had elevated ddimer, CT negative for PE, EKG and trop... Read more
Pleuritic chest pain, seen in ED, 12/31/2020, had elevated ddimer, CT negative for PE, EKG and troponin normal, Covid swab negative, diagnosed with pleurisy
44 2020-12-31 blood pressure increased, palpitations Rash from L arm, up to neck and down back, palpitations and dizziness within5 minutes of receiving v... Read more
Rash from L arm, up to neck and down back, palpitations and dizziness within5 minutes of receiving vaccine, elevated Bp. Treated with benadryl25mg oral. Symptoms returned within 45 minutes. Received another 25mg benadryl orally plus 40mg pepcid. Symptoms mostly resolved after that. Rash flared up again 4hours later. 25mg benadryl orally administered at home. Rash was present the next morning but resolved with no treatment.
44 2021-01-02 palpitations Diaphoretic palms, palpitations, jitteriness.
44 2021-01-03 hypertension 12/19 - fever, congestion, headache, cough 12/24 - body aches and night sweats in addition to the a... Read more
12/19 - fever, congestion, headache, cough 12/24 - body aches and night sweats in addition to the above 12/31 - add hypertension 1/04 - still have body aches, headache, cough, fever, hypertension
44 2021-01-03 hypertension 12/19 Started with fever, congestion, headache. 12/24 additional symptoms to include body aches, cou... Read more
12/19 Started with fever, congestion, headache. 12/24 additional symptoms to include body aches, cough, night sweat. 12/31 additional symptom of hypertension . As of today experiencing body aches, headache, cough, and hypertension. Medical Treatment 12/27/20 Urgent Care - 01/04/21 (virtual visit on 12/20)
44 2021-01-03 fast heart rate, hypertension, chest discomfort EXPERIENCED IMMEDIATE CHEST TIGHTNESS, TACHYCARDIA, AND HYPERTENSION. BROUGHT TO ED FOR MONITORING A... Read more
EXPERIENCED IMMEDIATE CHEST TIGHTNESS, TACHYCARDIA, AND HYPERTENSION. BROUGHT TO ED FOR MONITORING AND SYMPTOMS RESOLVED.
44 2021-01-03 chest pain, chest discomfort Fever (102.5 - 103.9), Pulse - 118, O2 - 94, Stabbing chest pain, Mediastinum tightness
44 2021-01-03 chest discomfort felt hot, prickly, right arm red. Later felt chest tightness
44 2021-01-04 palpitations, hypertension Anaphylactic Reaction, facial swelling, facial Redness, Face felt like it was burning, face flushin... Read more
Anaphylactic Reaction, facial swelling, facial Redness, Face felt like it was burning, face flushing, throat swelling, heart palpitations, trouble swallowing , feet swelling, light headed, anxiety. Hospitalized from the 12/23/20 to 12/26/2020 . Medications now on Epinephrine, diphenhydramine, cetirizine, famotidine, prednisone, lorazepam, cephalexin. on 1/1/2021 was taken to E.R. by ambulance around 11:00 am left hand was tingle started to go numb traveled up my arm into left side of my face ,ear, tongue, and then down to the left side of my leg and into left foot, could not move left side of body for a good 7 to 8 mins then went away transferred to ambulance enroute to ER blood pressure was high and and started having right ear pain and right side frontal severe headache, arrived to ER and was given diphenhydramine ,ketorolac, metoclopramide HCI, lorazepam. MRI was ordered and Neurologist found two small lesions on right side of frontal brain, following up now with neurologist. added more meds naproxen
44 2021-01-05 chest pain 15 minutes after the injection, I got some itching on my right shoulder near the injection site. I w... Read more
15 minutes after the injection, I got some itching on my right shoulder near the injection site. I waited around a bit longer and the itching and heat started to grow down my arm and across my chest and back. I was asked to go to the ER as it was not resolving. At about one hour, I started to get some mild chest pain, My BP was 173/101 and around 100+ for heart rate. O2 was 100% . ER staff did an EKG. The ER DR gave me Pepcid, Benadryl and Prednisone and 1 liter of normal saline. I was observed for about 3 hours. I went home and was feeling much better. The next 3 days I had a moderate headache and sore arm. I took Tylenol. I had some hot flushes and mild spikes of temperatures 100-101F, through the next couple of days.
44 2021-01-05 chest pain developed chest pain with radiation into axilla, shoulder, scapula and down the arm; axilla discomfo... Read more
developed chest pain with radiation into axilla, shoulder, scapula and down the arm; axilla discomfort; arm discomfort; Pain felt similar to sciatica; a full nagging pain and the muscles of my arm are fatigued from constant tension; a full nagging pain and the muscles of my arm are fatigued from constant tension; This is a spontaneous report from a contactable Nurse reported for herself. This 44-year-old female Nurse (patient) receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL1685), via an unspecified route of administration on 22Dec2020 09:30 at single dose on left arm for Covid-19 immunisation. There was no known allergies, medical history nor concomitant medications. Prior to vaccination, it was not unknown if the patient diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. 4 days following the vaccination on 26Dec2020 18:00, the patient developed chest pain with radiation into axilla, shoulder, scapula and down the arm. The chest pain and axilla discomfort subsided but the arm discomfort continued and intensified. Pain felt similar to sciatica. The patient took ibuprofen and paracetamol (TYLENOL) also placed ice pack under her arm and on top of shoulder. The following day the patient started on a methylprednisolone (MEDROL) dose pack. The patient received minor relief with the steroids and NSAIDs after 2 days she took a gabapentin (NEURONTIN) which was given to me by a family member. The gabapentin had given the most benefit. On day 4, the patient continue to have a full nagging pain and the muscles of her arm are fatigued from constant tension. The events resulted in doctor or other healthcare professional office/clinic visit. The outcome of the events was unknown. Since the vaccination, the patient had not been tested for COVID-19.
44 2021-01-05 fainting increased frequency of known recurrent syncope
44 2021-01-06 heart rate increased Approximately 10 minutes after vaccination developed increased heart rate, dizziness, and shakiness.
44 2021-01-07 palpitations, chest discomfort Driving home 18-20 mins post injection, my heart started racing, my hands were shaking, it became ha... Read more
Driving home 18-20 mins post injection, my heart started racing, my hands were shaking, it became hard to breathe, my fingers were tingling and my mouth got very dry. I pulled over and called 911. The paramedics stated my BP was within normal limits of around 140/80. My normal is closer to 90/65. Once symptoms resolved I attempted to drive home. Once again, the same symptoms returned. I pulled over. I then made my way to a safe location and waited for family to come. Since the event I have had times of mild labored breathing while walking. While driving I become very anxious and the feelings of an anxiety attack return. I saw my nurse practitioner 2 days ago who referred to the driving anxiety as a form of PTSD and prescribed Prozac and Xanax. I have not take the Xanax, but have taken two nighttime doses of Prozac. Yesterday, I did not feel as though I had taken medication. My drive to work was uneventful. My drive home involved tightening of the chest, labored breathing and anxiety. This morning I cannot tell if I am feeling the vaccine or Prozac in my system, but I feel off. Swimmy headed, watery mouth, heaviness in my arms and shoulders. I need guidance on taking the 2nd vaccine or if I should seek further medical treatment. I have added a vit B vitamin a day to my regimen since the date of the vaccine.
44 2021-01-07 chest pain Symptoms started 1/1/21 Pm. Headache, ear ache, chills, fever. COVID and influenza swabbed 1/5... Read more
Symptoms started 1/1/21 Pm. Headache, ear ache, chills, fever. COVID and influenza swabbed 1/5/21 both negative. Symptoms continued ear infection 1/6/21, nausea and chest pain. 1/7/21 vomiting and diarrhea started. Going in for COVID swab this am. And seeing a provider.
44 2021-01-08 chest discomfort On 12-23-2020, I developed symptoms of sinus congestion along with a cough, fever, body aches and a... Read more
On 12-23-2020, I developed symptoms of sinus congestion along with a cough, fever, body aches and a tightness sensation in my chest. I got tested for Covid on 12-27-2020 and was positive. I also had diarrhea and nausea. I did telemedicine with my primary healthcare doctor and I discussed with him that I felt tightness with pressure sensation to my chest and he said that it was cause of my asthma and he told me to take prednisone medication.
44 2021-01-08 loss of consciousness Patient was extremely anxious prior to vaccine. She told me she did get seizures but she took medic... Read more
Patient was extremely anxious prior to vaccine. She told me she did get seizures but she took medication for it and I informed her that it would still be recommended to get the vaccine. She was visibly anxious even after vaccine. Immediately after she began crying to her friend and said she "was just SO afraid of needles". I told her to take some deep breaths and after a minute or two she went to the observation room. Approximately 15 minutes later she rushed back into the room looking like she might hyperventilate or have hypoglycemia (shaking, cold sweats). She sat down and I tried to calm her down. I asked someone to get her orange juice. During the next couple minutes she did not seem to be getting any better and started shaking. I requested someone call 911. Another staff was helping so I moved to get and administer an epi-pen injection. By this time the patient was not responsive, but was still breathing. I instructed staff to help move her to the floor for monitoring and if needed, cpr. She regain partial consciousness. Her breath and pulse were always present, so there was no need to begin cpr. After a few minutes EMT arrived and transported patient to local hospital. During all of this, other employees at the facility were attempting to contact family members, which they were eventually able to do. About 30 minutes later the staff informed me they had spoken to family members who were at the hospital and that she was improving, but they had not seen her yet.
44 2021-01-08 fast heart rate Shortly after vaccination I developed tachycardia which continues to persist. Also in the last three... Read more
Shortly after vaccination I developed tachycardia which continues to persist. Also in the last three days I have started having violent shaking.
44 2021-01-10 chest pain, platelet count decreased, low platelet count, troponin increased 1/6/21 8pm started with Nasuea, vomiting, diarrhea and fever. 1/7/21 started having intermittent che... Read more
1/6/21 8pm started with Nasuea, vomiting, diarrhea and fever. 1/7/21 started having intermittent chest pain in the morning. Then in the evening it became constant. Went to ER that evening due to chest pain. EKG showed t wave abnormality. 1st Trop was negative went from 0.08 to 2.3 Had 2 Echo's done and they were normal. Platelets were 85. Was discharged without chest pain. Troponin on discharge was 0.67 and platelets 61. Was admitted due to Chest pain and troponin. Attending provider diagnosed as myocarditis and thrombocytopenia R/T vaccine.
44 2021-01-10 fast heart rate, chest discomfort Day of vaccination (Day 0) - felt mild chest tightness/difficulty breathing, relieved with 1 puff of... Read more
Day of vaccination (Day 0) - felt mild chest tightness/difficulty breathing, relieved with 1 puff of albuterol Day 1 - lymphadenopathy of left axilla lasted 2 days Day 2 - tachycardia HR 100, feeling faint, wanting to pass out for a couple of hours Day 4 - tachycardia HR 120 feeling faint, wanting to pass our for couple of hours
44 2021-01-11 heart rate increased About 10 minutes after shot, felt hot sensation go from ahoulders down rest if my body. My heart rat... Read more
About 10 minutes after shot, felt hot sensation go from ahoulders down rest if my body. My heart rate went to 140bpm. I alerted RN, gave me water, juice took about 20 minutes for HR to fo down to around 100. Did not go to ER. Went home, rested. HR returned to 80bpm around 3pm. Metoprolol taken two hours prior vaccine.
44 2021-01-11 heart rate irregular Flushing, irregular heart beat, redness on chest
44 2021-01-11 heart rate increased I had a reaction 20 minutes after the shot. My heart rate jumped up. The numbness and tingling was i... Read more
I had a reaction 20 minutes after the shot. My heart rate jumped up. The numbness and tingling was in my arm and up into my chest and back. I felt like I was going to pass out. The numbness and tingling still hasn't gone away and my heart still races.
44 2021-01-11 heart rate increased, chest discomfort Patient reported a heavy feeling in the chest, with tightness and fullness as well as difficult brea... Read more
Patient reported a heavy feeling in the chest, with tightness and fullness as well as difficult breathing. Patient also reported numbness of the lips. Symptoms occurred within 5 minutes of vaccine administration. Epinephrine 0.3mg pen was administered at 11:05 per protocol. One diphenhydramine 50mg capsule was administered at 11:07 per protocol. Patient reported easier breathing and increased heart rate almost immediately. Her throat felt like she "swallowed an ice-cube sideways". Within 10 minutes, the patient reported that her lips and throat felt better, but still tingles. States that it was "like she had recently shaved". A wheelchair was provided by the long-term care facility staff, and the patient was wheeled to the ER within the facility. Patient arrived at ER at 11:18 and pass-off to the ER team was completed around 11:20.
44 2021-01-11 palpitations pt felt heart racing, warm ears and face. Pt monitored and given water. Symptoms resolved at 1721.
44 2021-01-12 chest discomfort @0705 patient started to report slight swelling of lips and tight pressure in chest. No SOB. Also re... Read more
@0705 patient started to report slight swelling of lips and tight pressure in chest. No SOB. Also reporting numbness to lips as well. Same reaction to the initial dose. Patient stated it did not feel worse than the initial time. By 0735, symptoms resolved.
44 2021-01-12 palpitations About 1 hr and half , Developed redness started in my neck spreads to my face and both ears. Rashes ... Read more
About 1 hr and half , Developed redness started in my neck spreads to my face and both ears. Rashes noted in face and felt heart palpitations. Took ibuprofen and Benadryl twice. Redness and rashes dissipated. Generalized Muscle ache started at night lasted for 2 days.
44 2021-01-12 fainting, loss of consciousness nausea, syncope, LOC, fatigue
44 2021-01-13 palpitations, blood pressure increased, blood pressure decreased 5 minutes later - perfuse sweating, entire body hot, dizzy, elevated pulse and BP 147, heart palpita... Read more
5 minutes later - perfuse sweating, entire body hot, dizzy, elevated pulse and BP 147, heart palpitations; drank a juice & some water 10 minutes later - sweats/chills, still dizzy, BP decreasing 135, agitated 20 minutes later - still sweating,/chills, head clearing, heart palpitations subsiding, Tired, legs/body very heavy. Dizzy when walking, told to rest longer 30 minutes - still sweating/chills, could only walk short distance with heavy legs and dizziness, told to rest longer 40 minutes - massive headache, slight dizziness, continued leg heaviness. nausea, light sensitive, very itchy arm. Did not feel better until 11:30 PM that night Woke in the morning with just a sore arm, runny nose and an over-all fatigue, a little cough
44 2021-01-13 chest pain Per patient report: On 1/1/2021 she started to have a fever, HA, ear pain, neck pain (back of neck),... Read more
Per patient report: On 1/1/2021 she started to have a fever, HA, ear pain, neck pain (back of neck), and muscle aches in upper back. This continued through the weekend. On Wednesday, 1/6/2021, she saw a provider for ear pain, chest pain (radiating to right arm). She was not prescribed/given treatment regimen. On Thursday, 1/7/2021, night, she started to have vomiting diarrhea, and chest pain. On Friday, 1/8/2021, she went in to be seen for chest pain and r/o PE. States she has a history of PE and had a CT performed, no clots found. EE states does not have vomiting and diarrhea from 1/13/2021 for the first time since the start of this symptoms. Continues to have GI issues: decreased appetite and upset stomach. Also states she feels very fatigued.
44 2021-01-13 blood pressure increased, heart rate increased Staff had her 2nd dose on 01/12/2020 yesterday. This morning 6am wake up with bad headache. Went t... Read more
Staff had her 2nd dose on 01/12/2020 yesterday. This morning 6am wake up with bad headache. Went to work, 3:30 had blood pressure checked 174/102 and pulse was 98. Took Tylenol. Not dizzy. Monday covid negative
44 2021-01-14 palpitations 8 hours after injection Chest palpitations Nausea Vomiting Diarrhea Headache
44 2021-01-14 pallor Left supraclavicular lymphadenopathy started Dec 25th and still present, unchanged. Rash started o... Read more
Left supraclavicular lymphadenopathy started Dec 25th and still present, unchanged. Rash started on abdomen Jan 11th and progressive. worsening. Mildly itchy, spreading to back/arm/legs. Blanching. Fix eruption. Looks like pityriasis rosea
44 2021-01-14 fast heart rate, blood pressure increased Nausea, Dizziness, anxiousness, elevated Blood pressure, dry mouth, tachycardia
44 2021-01-14 chest pain feeling badly; chills; fever/ 101.6 fever; terrible muscle aches; headache; arm was so sore; Her arm... Read more
feeling badly; chills; fever/ 101.6 fever; terrible muscle aches; headache; arm was so sore; Her arm was so sore she couldn't even move it. She couldn't get herself dressed or undressed; chest pain; chest pain, going into her back, on her left side; This is a spontaneous report from a contactable other healthcare professional (patient). A 44-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK9231, NDC number: 5926710001), intramuscular on 07Jan2021 (around 10ish in the morning) at single dose at right arm for covid-19 immunization. Medical history included vertigo from an unknown date and unknown if ongoing. At the beginning of the week, patient had some vertigo but when she went in for her second vaccine, the vertigo was gone already. There were no concomitant medications. There was no adverse event following prior vaccinations. There were no additional vaccines administered on same date of the Pfizer suspect. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, NDC: 59267100002 Lot: EH9899) intramuscular on 17Dec2020 at single dose at right arm for covid-19 immunization. Patient received the second dose of the vaccine in the morning, around 10 something on 07Jan2021 at the hospital she worked at. She started feeling badly around 7:00 at night 07Jan2021 with chills, 101.6 fever, terrible muscle aches, a headache. Her arm was so sore she couldn't even move it. She couldn't get herself dressed or undressed. She was having chest pain, going into her back, on her left side. When probed for the outcome of these symptoms, patient stated she had a fever, but not quite as high. She had been taking paracetamol (TYLENOL) and it was not helping. Patient provided the following product information for the paracetamol she was taking: TYLENOL, 500mg NDC: 6984270778 Lot: 9MR0454 Expiry date: Oct2021. The back pain/muscle pain was still there. She had chills but not as badly. The soreness in her arm had improved. Her arm was still sore, but not like it was yesterday. Outcome of events feeling badly, headache and chest pain was unknown, outcome of events chills, fever/ 101.6 fever, arm was so sore she couldn't even move it was recovering, outcome of events back pain/muscle pain was not recovered. The report is considered as non-serious. The adverse events resulted in neither doctor or other healthcare professional office/clinic visit, nor emergency room/department or urgent care. History of all previous immunization with the Pfizer vaccine considered as suspect. No further information was provided or obtained.
44 2021-01-15 palpitations, chest discomfort About 10 mins after injection, felt chest tightness, palpitations, b/p 168/118. Then developed heada... Read more
About 10 mins after injection, felt chest tightness, palpitations, b/p 168/118. Then developed headache, dizziness, felt something stuck in throat and difficult to swallow. Also acid reflux. Sent to ER. B/P 170/98, still had feeling of difficulty swallowing, headache and acid reflux. Was given Tylenol, Pepcid and Ativan. After several hours B/p was normal and had slight headache when I went home. Following day felt tired and still with headache. Tylenol not helping.
44 2021-01-17 heart rate increased Injection given at 10:39 AM. HR increased in 30 minutes, later to 120. At 11:40, she noted pruritis ... Read more
Injection given at 10:39 AM. HR increased in 30 minutes, later to 120. At 11:40, she noted pruritis on arms and rash erupted - fine; erythema, warmth, HR 8, R 18, Pulse ox 97%, lungs clear. At 11:45, she noted tingling of the tongue, but no enlargement. Benadryl 25mg given PO at this time. At 12:00, she noted fingers tingling. At 12:20: HR 98, pulseox 97%. At 12:25: Rash, pruritis on right leg just below knees and behind the left knee.
44 2021-01-18 blood pressure increased Began with fever at 1030pm and continued with fever over 104 and lower back pain for 29 hours. Fever... Read more
Began with fever at 1030pm and continued with fever over 104 and lower back pain for 29 hours. Fever did not go below 102.9 with both motrin and Tylenol. Fever finally broke completely on 1/14 at 330am. At 300pm I spiked a fever at 104.6 within 5 minutes and had vigorous rigors and horrible lower back pain. I was at work in the hospital and turned blue as per other nurses and doctors. I was evaluated b/p 144/100 HR 130 lactate 4.9. I am 120lb and have never had a b/p higher then 120. After NS Tylenol 2 liters of Lactated ringers my fever was 103.3 and the rigors stopped. I never had elevated wbc and my covid they did in the ER was negative. I went home. For the next 24 hours I continues with intermittent fevers. The next day I began with runny nose and sneezing. Since then I am very congested with headaches all day relieved partially with Motrin but never fully relieved.
44 2021-01-18 chest pain, blood pressure increased I had moderate reaction to first vaccine where I had to go to the ER, for rash on my arm and chest/b... Read more
I had moderate reaction to first vaccine where I had to go to the ER, for rash on my arm and chest/back, increase blood pressure and chest pain. Pepcid, benadryl and prednisone were given to me in the ER and a liter of fluids. VAERS number Date Form Completed: 01/06/2021 Temporary VAERS E-Report No: 223935 So on the second dose, I premedicated the night before 8pmwith 20mg of prednisone, 10mg of claritin, and 40mg of pepcid. In the morning 9am I took 40 mg of pepcid, 20 mg of predisone and 30 minutes prior to second vaccine around 12pm, I took 25mg of benadryl. After vaccine , I had severe nausea at about 20 minutes (1240p), and increase blood pressure at about 30 to 40 minutes. 156/94 was my highest. I had fewer areas of itching and specks of rash and itching around my back than on the first dose that I took. If I did not premediate, I am sure I would have had a similar or worse reaction since I still had similar reaction but milder.
44 2021-01-18 heart rate increased Rapid heart beat for three weeks. Takes medicine for anxiety.
44 2021-01-18 deep vein blood clot Visited Provider appx 500 pm 1.14.2021 DVT - left calf - 2 clots via ultrasound on Eliquis no... Read more
Visited Provider appx 500 pm 1.14.2021 DVT - left calf - 2 clots via ultrasound on Eliquis now
44 2021-01-18 fast heart rate tachycardia which continues to persist; intermittent violent shaking; This is a spontaneous report f... Read more
tachycardia which continues to persist; intermittent violent shaking; This is a spontaneous report from a contactable healthcare professional (patient). This 44-year-old female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: Eh9899, expiry date: unknown, vaccine location: left arm, dose number: 1), via an unspecified route of administration on 21Dec2020 16:30 at a single dose for COVID-19 immunization. Medical history included dermatomyositis (not receiving any treatment). The patient had no known allergies. The patient's concomitant medications were not reported. Shortly after vaccination on 24Dec2020, the patient developed tachycardia which continues to persist. Also, on 24Dec2020, the patient developed intermittent violent shaking. Treatment was received for the adverse events. EKG and lab work were done. The adverse events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient is not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The events were reported as non-serious. The events did not result in death, were not life-threatening, did not cause or prolong hospitalization, were not disabling or incapacitating, and did not result to a congenital anomaly or birth defect. Outcome of the events was not recovered.
44 2021-01-20 hypertension, lightheadedness, heart rate increased near syncope; Sinus Tachycardia; Hypothyroidism; tested positive for Covid 19; tested positive for C... Read more
near syncope; Sinus Tachycardia; Hypothyroidism; tested positive for Covid 19; tested positive for Covid 19; lost weight; No sense of taste or smell; No sense of taste or smell; losing hair; heart rate started increasing; high blood pressure; Increased cough; Sleepy; tired; Headache; This is a spontaneous report from a contactable other healthcare professional (patient) through the Medical Information Team and Pfizer-sponsored program Pfizer First Connect. A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0140), intramuscularly on the arm on 19Dec2020 11:15 at a single dose for COVID-19 immunization. Medical history included tachycardia and stroke from 2019 and diabetes mellitus diagnosed in summer of 2020 and ongoing. Family medical history included father had type 2 diabetes. Concomitant medication included metformin hydrochloride, sitagliptin (JANUMET) for diabetes. The patient previously took regular flu shot and had body aches; it did not happen at the year of report but in years past she did have it. The patient took the COVID vaccine for precaution as she was a healthcare worker/paramedic and stated there was no prescriber. She received the vaccination at a health department facility, not a military facility. She had no previous immunizations and no additional vaccines were administered on the same date as COVID-19 vaccine. The patient received her first dose of COVID-19 vaccine on 19Dec2020 and after nine days, she tested positive for COVID-19 on 30Dec2020 and had an inpatient hospital stay. She mentioned she was so happy that she did not have any symptoms for those days. She stated that she got the shot on the 19th and later that evening was when she started having symptoms. She tried to sleep and it woke her up, she felt sleepy, tired and experienced headache on 19Dec2020 20:00 to 21:00. On 28Dec2020 23:00, she had an increased cough. She initially had increased cough from wearing mask and was having post nasal drip, then she got wet cough and that was when she decided to get tested. She went back and forth on dates; stated she was confused with the dates because of being in the hospital, it had been a while and the dates were all meshing in together. Her specimen was collected and they did the test on 29Dec2020 then found out that she tested positive for COVID virus with a COVID test nasal swab on 30Dec2020 17:30. She mentioned she lost weight after she got COVID, had no sense of taste or smell on unspecified dates. She did not know if it was related to her thyroid but she started losing hair and her heart rate started increasing on Monday, so they took her off all her meds and said the COVID was doing crazy things to the body. She had to go on Carvedilol for the sinus tachycardia and had high blood pressure now. This was all new after she tested positive. She has had bouts of tachycardia before and did have a heart monitor as she had a stroke last year. So those have never been persistent or symptomatic. If she did have a high heart rate, it always went down. This one was symptomatic. She did fine the whole week after the shot, just had that little bit of sleepiness, was tired, and had a headache. The patient reported near syncope with sinus tachycardia due to COVID-19 and hypothyroidism on 08Jan2021 14:30 to 15:00, which required hospitalization from 08Jan2021 to 10Jan2021 (2 days). ER or physician's office was required. She never went to the ER for the vaccination, it was just for the near syncope with sinus tachycardia due to COVID-19 and hypothyroidism that she went and was then admitted to hospital. She just got out of the hospital the day before report (10Jan2021), was there for two days and was still recovering. She was supposed to receive her second vaccination on the day of report however her doctor did not know if she should get the second dose due to double antibodies. She did not ask if she still had the virus or it went away. She has not been to work in two weeks. Outcome of the events tested positive for COVID virus was not recovered; near syncope with sinus tachycardia due to COVID-19 and hypothyroidism was recovered with sequel; sleepy, tired and headache was recovering; while the remaining events was unknown.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
44 2021-01-21 heart rate increased COVID-19 Vaccine EUA; Difficulty breathing, swelling of my face and throat, fast heartbeat, itchines... Read more
COVID-19 Vaccine EUA; Difficulty breathing, swelling of my face and throat, fast heartbeat, itchiness all over, dizziness and weakness.
44 2021-01-21 chest discomfort Chest tightness, shortness of breath, cough. Symptoms resolved with breathing tx in ER. Recovered fr... Read more
Chest tightness, shortness of breath, cough. Symptoms resolved with breathing tx in ER. Recovered from covid several months ago.
44 2021-01-21 palpitations Palpitations
44 2021-01-21 fainting Severe arm pain and was unable to sleep even with tylenol Right eye swelling Right eye whites of eye... Read more
Severe arm pain and was unable to sleep even with tylenol Right eye swelling Right eye whites of eye bloody Abdominal pain for 3 days unable to sleep due to discomfort Nausea off and on for 3 days with abdominal pain Fatigue Faint with abdominal pain Light headed off and on
44 2021-01-21 loss of consciousness Two grand mal seizures and went unconscious. Prior to seizures felt very lethargic.
44 2021-01-21 hypertension, fast heart rate, chest discomfort Within 15 minutes: L. side numbness/tingling, chest tightness, coughing/sob, HTN, Tachycardia -- "c... Read more
Within 15 minutes: L. side numbness/tingling, chest tightness, coughing/sob, HTN, Tachycardia -- "code called" -- pt. given epi, oxygen, transferred to ED.
44 2021-01-21 chest pain woke up with left sided chest pain and thought she may be having an MI; Injection received in left a... Read more
woke up with left sided chest pain and thought she may be having an MI; Injection received in left arm, resulting in extreme left side pain and soreness; woke up with left sided chest pain and thought she may be having an MI; Left upper body continues to be sore, not only at injection site but also left axillary area; Left arm is still warm although vaccine was received 72 hours ago; This is a spontaneous report from a contactable pharmacist (patient). A 44-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1284), via an unspecified route of administration in the left arm on 08Jan2021 07:45 AM at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient has no known allergies. Patient was not pregnant. Patient has no COVID-19 prior to vaccination. No other vaccines was given in four weeks. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EJ1685) given in the left arm on 21Dec2020 at 02:00PM for COVID-19 immunization. On 09Jan2021 at 03:00 PM, the patient experienced injection received in left arm, resulting in extreme left side pain and soreness. She woke up with left sided chest pain and thought she may be having an MI. Left upper body continues to be sore, not only at injection site but also left axillary area. This pain was not noted with her first vaccination. Left arm was still warm although vaccine was received 72 hours ago. This was not noted with her first vaccination. No treatment was given for the reported events. Patient was not tested for Covid post vaccination. The outcome of the events was recovering.; Sender's Comments: Based on the close temporal relationship, the association between the event myocardial infarction with BNT162b2 can not be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
44 2021-01-22 chest discomfort, loss of consciousness 10 mins after first dose, pt reports feeling lightheaded, dizzy, SOB, and chest tightness. Pt denies... Read more
10 mins after first dose, pt reports feeling lightheaded, dizzy, SOB, and chest tightness. Pt denies numbness/tingling, sore throat, throat swelling, hives or fever. SBPs around 150s (normally in the 90s). Feels like she is going to pass out. Symptoms resolved and pt discharged at 2325.
44 2021-01-22 palpitations, hypertension About 10 min after injection I began to feel dizzy, then had 1 faint wheeze at the base of my chest,... Read more
About 10 min after injection I began to feel dizzy, then had 1 faint wheeze at the base of my chest, I became nauseous, then developed rapid palpitations. I BP was checked about 10 min later and I was hypertensive SBP 180s. By the HR was down to about 90 bpm and I felt the palpitations begin to decrease. I was feeling better by about 10 min later and went home. I also had itchiness of the L hand for about 1 hr afterwards.
44 2021-01-22 palpitations Racing heart, dizzy, flushed face, headache
44 2021-01-22 chest discomfort Tightness in chest, cough and shortness of breath
44 2021-01-24 lightheadedness Lower extremity weakness, dysarthria, presyncope
44 2021-01-25 blood pressure increased Approximately 20 minutes after receiving the COVID vaccination (2nd dose), patient reported dizzines... Read more
Approximately 20 minutes after receiving the COVID vaccination (2nd dose), patient reported dizziness and blurred vision. Patient was walking at the time and was then sat down. Patient was clammy and diaphoretic, blood pressure was elevated from her normal and O2 was normal. Patient reported feeling a thickness in her throat, similar to mucus but no trouble breathing. Ambulance was called and she was taken to the ER by paramedics, was not able to stand to get on stretcher and was helped on by paramedics.
44 2021-01-25 blood pressure increased Approximately 20 minutes after receiving vaccination, patient reported dizziness and blurred vision.... Read more
Approximately 20 minutes after receiving vaccination, patient reported dizziness and blurred vision. Patient almost fell while walking and was sat down. Patient was clammy and diaphoretic and blood pressure was elevated from her normal but O2 was normal. No swelling but patient reported drainage in her throat, a thick mucus like feeling. Ambulance was called and patient was taken away on stretcher, was not able to stand to get on stretcher.
44 2021-01-25 chest pain ED provider notes as follows: Initial Vital Signs [01/20/21 0010] Blood Pressure 136/74 Heart Rate ... Read more
ED provider notes as follows: Initial Vital Signs [01/20/21 0010] Blood Pressure 136/74 Heart Rate 82 Respiratory Rate 20 Temp 36.7 °C (98.1 °F) Temp src Oral SpO2 98 % 44 y.o. female who arrived to the emergency department for Episode of right mid anterior chest pain intermittently ongoing starting around 10 PM this evening. She has had similar episodes in the past thought to be related to her gallbladder. Tonight she took some Pepcid and Tylenol. She denies any shortness of breath, or persistent chest pain, states pain has resolved since arriving in the emergency room. She denies any recent fever however she was recently given the second vaccine dose for COVID, and is having myalgias and symptoms she believes are related to the vaccination. She is requesting a COVID test. Patient denies sore throat, cough or abdominal pain. At this time only symptoms or myalgias. She continues to have no symptoms, her workup is reassuring, low suspicion for severe significant pathology, however would have a low threshold to return to the ER if chest pain would return or any other symptoms were to arise. COVID test came back negative.
44 2021-01-25 heart rate increased Rapid heart rate approximately 12 hours after dose. Continued throughout the day. Rate approximatel... Read more
Rapid heart rate approximately 12 hours after dose. Continued throughout the day. Rate approximately 160-170s. Then about 40 hours after vaccination a rash developed. Previous history of viral rashes. Rash covered front and back of trunk took benadryl but lasted approximately 2 days. Lastly, on 1.25.2021, had a CT with contrast for another medical concern (not related) ended up having an allergic response to the contrast. Has had multiple CT over the years (greater than 10) has never had a reaction.
44 2021-01-26 chest discomfort Patient described feeling flushed and hot all over, some tightness in the chest, anxiety and ringing... Read more
Patient described feeling flushed and hot all over, some tightness in the chest, anxiety and ringing in her ears, tension in her neck and arm in the left side where she received the vaccine. Took her pulse and lay her on a cot, gave her water. After about 20 minutes of rest, she felt well enough to drive home.
44 2021-01-26 blood pressure increased, heart rate increased, blood pressure decreased Received Pfizer COVID 19 vaccination (Dose 1) at 10:07a.m. Itching - 10 minutes post vaccination Vis... Read more
Received Pfizer COVID 19 vaccination (Dose 1) at 10:07a.m. Itching - 10 minutes post vaccination Visible hives, shortness of breath, and rapid heart beat- 25 minutes post vaccination Decreased BP, followed by increased BP - 30 minutes post vaccination Given 50 mg chewable children's Benadryl at facility: 35 minutes post vaccination EMS called: approximately 40 minutes post vaccination EMS placed IV, pushed epinephrine and solumedrol, and transported me to Hospital. Emergency Department: pushed another dose of epinephrine, Benadryl, and Pepcid. I also received an EKG. Discharged from ED at 4pm Relapse in symptoms (Shortness of breath, nausea, rapid heart rate, and hives): 7p.m. Return to ED at 9pm and discharged at 1 a.m. 1/16/2021
44 2021-01-26 fast heart rate, chest discomfort Received allergy immunotherapy on 1/21/21 and had itching, difficulty breathing, tightness in throat... Read more
Received allergy immunotherapy on 1/21/21 and had itching, difficulty breathing, tightness in throat/chest, flushed skin and tachycardia after. Received Antihistamines, Albuterol treatment and steroid for treatment.
44 2021-01-27 palpitations 40 sec after injection to left arm, flushed sensation to left side neck then to left ear, then to ... Read more
40 sec after injection to left arm, flushed sensation to left side neck then to left ear, then to forehead, to right ear and to right side neck, followed by sudden throat dryness. BP 165/122, HR 120, Pts normal BP 90-100 systolic 80's diastolic, Hr usually 80's. about 1 hr later mild headache, left arm soreness. 2nd day after sensation of palpitations, day 3 sensation of palpitations, HR 108 on one measurement.
44 2021-01-28 blood pressure decreased Headache, dizziness, burning tingling lips, nausea, rash on chest, drop in blood pressure
44 2021-01-28 pallor, hypertension, loss of consciousness Hives, chills, hypertensive, bradycardia, pallor, felt like she was going to pass out
44 2021-01-28 chest pain Patient reports pain/discomfort in chest and abdomen shortly after vaccine. States she experienced ... Read more
Patient reports pain/discomfort in chest and abdomen shortly after vaccine. States she experienced shortness of breath, headache, and fatigue for 2 weeks after vaccination. A day after vaccine, reports multiple episodes of subjectively bloody diarrhea. An evaluation by GI showed now abnormal findings. Patient tested for COVID and was negative. Advised not to get second dose of vaccine.
44 2021-01-28 hypertension Right after the shot I had itching, tingling, and red spots all down my arm, then my throat swelled ... Read more
Right after the shot I had itching, tingling, and red spots all down my arm, then my throat swelled a bit and I became sweaty. Nurse checked my blood pressure and it was very high for me (144/83) usually 117/78. Nurse administered one Benadryl tablet and I felt better within about 15 minutes. Now I just feel very tired.
44 2021-01-31 chest discomfort 10am Pt c/o SOB, tightness in chest, left arm numbness, dizziness. BP 127/84 P-108 PO 100%. RN ca... Read more
10am Pt c/o SOB, tightness in chest, left arm numbness, dizziness. BP 127/84 P-108 PO 100%. RN came to assist. 10:04am Benadryl 25 mg liquid given PO BP121/73 P 104 PO 97%. Left arm injection site asymptomatic. Pt states this is her 2nd Covid vaccine and did not react to the first one. Pt states she had anaphylactic reactions to PCN, ASA, Sulfa, Keflex and Codeine in the past. C/O blurred vision. 10:10am BP 132/81 p 112 PO 98% with same symptoms. RN present and we discussed going to ER, vs stable and patient declined going. 10:15am BP 133/82 P-114 PO 96%, pt states her breathing is better, thinks the Benadryl caused the dizziness, continued blurred/fuzzy vision, not double vision, A & O x3. 10:20am BP 127/83 P-108 PO98% denies SOB and chest tightness, states she feels better. Crackers, juice and water given. 10:25am BP 123/83 P 105 PO 98% pt states blurred vision has gone. 10:30am BP 129/70 P 105 PO 97% continue to feel better. Talking to her co-worker about getting a ride back to work with her after she receives her vaccine. 10:55am BP 120/72 P 105 Sat 99% went to restroom with another nurse and states she feels fine standing. 11am BP 126/75 P98 PO 98% denies arm numbness, blurred vision and SOB/chest tightness. Report off to 11am Volunteer RN for the monitor room.
44 2021-01-31 chest discomfort CHEST TIGHTNESS , DIFFICULTY BREATHING AND SCRATCHY THROAT TREATED WITH STROIDS ,BENADRL AND EPI
44 2021-01-31 fast heart rate, hypertension Patient described arm pain at the site of injection soon after injection. Began to develop difficult... Read more
Patient described arm pain at the site of injection soon after injection. Began to develop difficulty swallowing, which the patient described as her tongue feeling heavy and her throat feeling tight. Adult EpiPen was administered at 10:33 AM with PO diphenhydramine 25 mg immediately after. Symptoms resolved. Patient was tachycardic (~100) and hypertensive 140/100. EMS arrived and brought patient to emergency department for additional testing/monitoring.
44 2021-02-01 chest discomfort Report right arm pain, cough and chest tightness. Treatment: None. Outcome: Arm pain resolved, cough... Read more
Report right arm pain, cough and chest tightness. Treatment: None. Outcome: Arm pain resolved, cough and chest tightness continues.
44 2021-02-03 fainting Dizziness, nausea, Fainting, extreme headaches, brain fog, impacted depth perception, extreme muscle... Read more
Dizziness, nausea, Fainting, extreme headaches, brain fog, impacted depth perception, extreme muscle pain, knots in large muscles, diarrhea.
44 2021-02-03 heart rate irregular I began to have fever, chills, muscle aches, joint aches, and rapid heartbeat. They lasted approxim... Read more
I began to have fever, chills, muscle aches, joint aches, and rapid heartbeat. They lasted approximately 36 hours.
44 2021-02-04 fainting 15 min after vaccine administered patient stated she had a frontal headache radiating to her right s... Read more
15 min after vaccine administered patient stated she had a frontal headache radiating to her right side of head and tinglinig around her lips. She was instructed to stay for an additional 15 min for observation. She was placed on a stretcher to lie down. She was conversing and her S/S went unchanged. At approx 1 pm she became unresponsive, she did not wake with touch or verbal command Her eyelids were fluttering as if she was experiencing a seizure. A condition was called. Pulse ox 100 % blood sugar 90. Monitor NSR. She remained unresponsive and was taken to the ED. Upon arrival to the ED at approx 1:17 pm, the ED nurse stated she was awake. Evaluated by physician, labs and CT head ordered. Patient stated all lab work and CT scan was normal. Employee was discharged with a diagnosis of vasovagal near syncope.
44 2021-02-04 chest pain It began with right arm soreness and progressed to aches and low grade fever within the first 24 hou... Read more
It began with right arm soreness and progressed to aches and low grade fever within the first 24 hours. Then it moved on to mid-sternal chest pain that radiated to my back and I had shortness of breath that increased with deep breathing after about 48 hours.
44 2021-02-04 palpitations, fast heart rate, blood pressure increased Patient reported feeling heart racing; Assessed as tachycardic, HR 130, BP 134/64 @11:40, BP 150/80 ... Read more
Patient reported feeling heart racing; Assessed as tachycardic, HR 130, BP 134/64 @11:40, BP 150/80 @11:55, BP 167/105 @12:03, BP 181/96 @12:24; O2 sat 99%. Transported to the ED. Spent 3 hours in the ED BP down to 130/ Then discharged home. No recurrent episodes. Does not have history of high blood pressure.
44 2021-02-04 pallor, hypotension low blood pressure; pale and diaphoretic; pale and diaphoretic; Pain injection site; nausea and feel... Read more
low blood pressure; pale and diaphoretic; pale and diaphoretic; Pain injection site; nausea and feeling faint; nausea and feeling faint; This is a spontaneous report from a contactable nurse and a contactable consumer. A 44-year-old female patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL3247, Expiration Date: 31May2021), via an unspecified route of administration on 19Jan2021 at 14:00 at 0.3 mL, single on deltoid left for covid-19 immunisation. Medical history included panic attack. There were no concomitant medications. Patient received the vaccine on 19Jan2021 at around 14:00 in her left deltoid. Pain at injection site started at 14:10 on day of injection, patient came to observation area with pain at injection site, nausea and feeling faint. After that, the nurse in observation area took blood pressure (BP) at 14:12 and blood pressure was 88/60 and pulse was 78 and O2 sat 88 on room air, pale and diaphoretic at this time. Treatment: patient legs elevated, offered juice and water. Patient was able to swallow. Nurse in observation placed call to 911 at this time. 14:17 BP rechecked 118/82 and pulse was 78 and Sat 98% and starting to feel better. 14:20, blood pressure was taken again 120/84 pulse 80 and O2 Sat 98%, patient was returned to upright position and stated they felt so much better, cancelled EMS (Emergency Medical Services). Patient stated at this time that she had a history of panic attacks and she felt that she worked herself thinking about the vaccine. Did call doctor in charge of clinic and checked out the patient. Checked on patient the following day and stated that she was fine and going back to work. Outcome of the events was resolved.
44 2021-02-04 heart rate increased rapid heart beat; severe anxiety; This is a spontaneous report from a contactable healthcare profess... Read more
rapid heart beat; severe anxiety; This is a spontaneous report from a contactable healthcare professional (patient). A 44-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on the left arm on 20Jan2021 09:15 at single dose for COVID-19 immunization. Medical history included allergies: artificial orange in food and anxiety. Concomitant medication included ethinylestradiol, norgestimate (SPRINTEC) for birth control. The patient previously took first dose of BNT162B2 for covid-19 immunization on an unspecified date; and ammonia and experienced allergies. The patient was not pregnant at the time of vaccination. On 20Jan2021 14:00, the patient experienced rapid heartbeat and severe anxiety. The patient didn't go to the hospital and just worked through it herself as she has anxiety anyway. This lasted for about 4 hours. The patient did not receive treatment for the events. Prior to vaccination the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was recovered on 20Jan2021.
44 2021-02-07 heart rate increased, blood pressure increased Client reports tingling in arms, face, hands down to feet and felt lightheaded and dizzy. Client rep... Read more
Client reports tingling in arms, face, hands down to feet and felt lightheaded and dizzy. Client reports lasting about an hour, increased then plateaued and then decreased with taking Benadryl. Similar circumstances with first vaccination lasting approximately 1.5 hours. Increased heart rate and increase blood pressure during both circumstances.
44 2021-02-07 heart rate increased HR 158 to 132; bp 148/70; o2 sat 99-100%; monitored 15 minutes additional; bp 122/70 8 minutes later... Read more
HR 158 to 132; bp 148/70; o2 sat 99-100%; monitored 15 minutes additional; bp 122/70 8 minutes later hr 120; patient states she feels better and wanted to go home;
44 2021-02-09 palpitations At 9:05 am client states she felt shortness of breath and her heart racing. Vital signs obtained by... Read more
At 9:05 am client states she felt shortness of breath and her heart racing. Vital signs obtained by EMS, BP 135/83, pulse 90, Report O2 sat 99%, pulse 92. Client states she is feeling better. EMS discharge client. Client left vaccine site at 9:10 am.
44 2021-02-19 heart attack Patient suffered a heart attack on 2/17/2021
44 2021-02-21 palpitations Patient came to us with complaints of her heart racing, feeling like she needed "fresh air" and slig... Read more
Patient came to us with complaints of her heart racing, feeling like she needed "fresh air" and slight itch to throat. NP and RN on sight assessed patient and had her sit in reclining chair with some water. 50 mg of Benadryl were administered orally at 1630. By 1720 patient was feeling better and her husband came to pick her up
44 2021-02-21 loss of consciousness Started with nausea and Headache the day of the vaccine shot. The following day I had nausea, throwi... Read more
Started with nausea and Headache the day of the vaccine shot. The following day I had nausea, throwing up, light-headed, and actually blacked out momentarily. Treatment included: taking Excedrin for Migraines and an anti nausea medication. I slept for most of the day following the shot and the entire night the next day and the next night. All total sleep was probably a total of 25 - 30 hours of a 48 hour period following the vaccine. Still feeling nauseous and having headaches five days after taking the shot.
44 2021-02-22 chest pain 5:30pm 2/22/21 started feeling ache ate dinner: 7:30pm started vomiting with fever of 100: 9pm sever... Read more
5:30pm 2/22/21 started feeling ache ate dinner: 7:30pm started vomiting with fever of 100: 9pm sever chills with sweats: 9:30pm vomited layed down: 1am woke sweating shivering fever still 100 took a shover started extreme body aches with chest pain: drove myself to Stony Brook ED: labs ran covid swabbed still with all symptoms: chest xray preformed: released at 6am was told to monitor symptoms and if I can not keep anything down like water and or still with chest pain after 24hrs return to ED
44 2021-02-22 cerebrovascular accident Dizziness; stoke like symptoms; lost taste; Lost smell; lost hearing; weakness; right eye droopy; Th... Read more
Dizziness; stoke like symptoms; lost taste; Lost smell; lost hearing; weakness; right eye droopy; This is a spontaneous report from a contactable other hcp (patient). A 44-year-old female patient receive first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL0142), at same age, via an unspecified route of administration in left arm on 05Jan2021 10:00 at single dose for covid-19 immunisation. Medical history included high blood pressure. Concomitant medication included metoprolol. The patient previously took ampicillin and experienced drug allergy. The patient experienced dizziness, stoke like symptoms, she lost taste, smell, hearing, lost station on my whole right side. Right side weakness. Only one eye blinks right eye droopy, all on 05Jan2021 10:00. Events resulted in emergency room visit. The patient was hospitalized for 1 days for all events. It was unknown whether treatment was received for all events. Patient is not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was hospital. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient underwent lab tests and procedures which included nasal swab/ covid test: negative on 08Feb2021. The outcomes of events were not recovered.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported dizziness, stoke like symptoms, she lost taste, smell, hearing, lost station on my whole right side, right side weakness, only one eye blinks right eye droopy, and the administration of the COVID 19 vaccine, BNT162B2, administration, based on the reasonable temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
44 2021-02-23 palpitations, pallor Patient complained of numbness/tingling of hands & feet, pale face and feeling cold with heart racin... Read more
Patient complained of numbness/tingling of hands & feet, pale face and feeling cold with heart racing.
44 2021-02-23 fast heart rate Patient reported on 2/9 that she started having shortness of breath, rapid HR, itchy skin, hand and ... Read more
Patient reported on 2/9 that she started having shortness of breath, rapid HR, itchy skin, hand and feet redness. Her endo specialist advised her to take Claritin gel caps for 3 days. The reaction lasted 2 days and was advised not to take the 2nd shot.
44 2021-02-24 chest discomfort Had reaction with first dose. Given Benadryl 50 mg oral at 17:00 just prior to vaccine administratio... Read more
Had reaction with first dose. Given Benadryl 50 mg oral at 17:00 just prior to vaccine administration. Within 10 minutes of vaccine administration she developed scratchy throat, felt like lump in throat, then progressed to itching all over body, no visible rash, became nauseated and dizziness. Denied any SOB or tongue swelling. About an hour after vaccine given began to vomit. Patient then transported to ED for further evaluation and treatment. Admitted to ED at 18:25 where she received Decadron 10mg IV, Pepcid 20mg IV and Zofran 4mg IV. Vomiting resolved as well as chest tightness, dizziness, headache, throat itching resolved. She was dismissed from ED at 20:03.
44 2021-02-25 blood pressure increased Patient was observed post Covid-19 immunization for 30 minutes based on pre-vaccination screening an... Read more
Patient was observed post Covid-19 immunization for 30 minutes based on pre-vaccination screening and reported to RN that she was feeling lightheaded and dizzy after about 20 minutes of observation. States she is feeling slightly anxious. BP 160/96 pulse 108 sat 98%. Patient is not reporting any other symptoms. Patient reports a History of HTN and anxiety States she does not normally feel lightheaded/dizzy. States this BP is elevated for her. Patient given water and crackers, with slight relief of dizziness. EMS called and at pt side for evaluation. At 1212p, Bp 173/91, hr 94, sat 97% given cracker and water, which patient stated made her feel slightly better. EMS evaluating patient Emotional support provided. At 1220, BP 182/98, pulse down to 85, with sats at 95%. Patient feeling better. EMS transported patient to a quite space and continued to monitor. Patient speaking with husband as well. At 1242, EMS released stating patient feeling better and BP down to 160/90. Patient encouraged to discuss with PCP events. She was provided with Vaccine Information Sheet and instruction to access the V-Safe system. Patient was observed post Covid-19 immunization for 30 minutes based on pre-vaccination screening and reported to RN that she was feeling lightheaded and dizzy after about 20 minutes of observation. States she is feeling slightly anxious. BP 160/96 pulse 108 sat 98%. Patient is not reporting any other symptoms. Patient reports a History of HTN and anxiety States she does not normally feel lightheaded/dizzy. States this BP is elevated for her. Patient given water and crackers, with slight relief of dizziness. EMS called and at pt side for evaluation. At 1212p, Bp 173/91, hr 94, sat 97% given cracker and water, which patient stated made her feel slightly better. EMS evaluating patient Emotional support provided. At 1220, BP 182/98, pulse down to 85, with sats at 95%. Patient feeling better. EMS transported patient to a quite space and continued to monitor. Patient speaking with husband as well. At 1242, EMS released stating patient feeling better and BP down to 160/90. Patient encouraged to discuss with PCP events.
44 2021-02-26 palpitations Palpitations, flushing, dizziness, shaky, chills, evaluated by EMS-cleared
44 2021-02-26 blood pressure increased The patient felt more pressure on her eyes than usual. She stated that her eyes felt different, ther... Read more
The patient felt more pressure on her eyes than usual. She stated that her eyes felt different, there were halos on the lights, itchy eyes, itchy throat, and her body felt warmer. She had an increased blo0od pressure of 150/100mmHg.
44 2021-02-27 chest discomfort, chest pain Ear pain 2 minutes after injection Left arm completely numb 8 minutes after injection Hot flashes ... Read more
Ear pain 2 minutes after injection Left arm completely numb 8 minutes after injection Hot flashes 10 minutes after injection Chest pain and tightness 15 minutes after injection Brain fog delayed movement thyroid meds left my system 20 minutes after injection
44 2021-02-27 heart rate increased First light dizziness increased to severe dizziness. Feeling the need to vomit No ability to swallo... Read more
First light dizziness increased to severe dizziness. Feeling the need to vomit No ability to swallow Shortness of breath Rapid heartbeat (130) Paramedics took vitals blood pressure and heart rate. I was asked to lay on gurney which I refused. I sat in chair. Paramedics monitored for 45 minutes until everything returned to normal. Walked to car by paramedics. Mom needed to drive home I was unable to.
44 2021-02-28 chest discomfort, hypertension Chest tightness experienced accompanied by high blood pressure and light headedness which started on... Read more
Chest tightness experienced accompanied by high blood pressure and light headedness which started on 2/2/21 at around 1900. Visited urgent care on 2/3/21, EKG, cardiac enzymes, and CBC drawn. EKG read abnormal. Cardiology consult was suggested. Symptoms persisted until 2/7/21.
44 2021-02-28 pulmonary embolism, chest discomfort, chest pain, blood pressure increased Pt presented to ED 45 minutes after receiving 1st dose Pfizer COVID vaccine with elevated BP, itchin... Read more
Pt presented to ED 45 minutes after receiving 1st dose Pfizer COVID vaccine with elevated BP, itching, rash and hives. Pt PE upon arrival stated that she was in acute distress. Itching,rash,hives,swelling and redness present on pt's back, chest and left arm. Progression: worsening. Moderate severity. Pt had taken lisinopril 10 mg with no improvement. Pt was treated with steroids, H1 and H2 blockers with good response. 02.01.2021 Pt presented to ED with BP of 200/140. Pt reports BP has been elevated since receiving her COVID vaccine on 01.29.2021. Pt exam positive for tinnitis. BP @ 1253 144/98, 1152 170/107, 1130 185/112, 1126 190/124. Pt BP came down with self administered hydralazine. 02.04.21 Pt presents to Ed with elevated BP of 161/111 and chest pressure. Pt has not had relief with dose of clonidine and hydralazine. She also took a dose of steroid. Pt ROS pos for chest tightness, chest pain and leg swelling. BP improved with anxiolysis.
44 2021-02-28 hypertension Sat 5pm eyeballs began to hurt. The entire eyeball was painfully sore. At night I woke up with ton... Read more
Sat 5pm eyeballs began to hurt. The entire eyeball was painfully sore. At night I woke up with tongue that felt thick or swollen. Then the next am woke up with aches, headache, chills, hot (suspected fever but did not get up and check) tiredness. Spit up yellow fluid (thought it might be from GERD) and laided around all day. Did not eat as stomach felt nauseated. At 3 pm I ate half a sandwich and at 4 ate half a banana and drank some water and 1/4 of cup of sweet tea. By 6pm I was really sick to my stomach got up and threw up sandwich and banana. I thought I saw some blood but was not sure. I continued to throw up and it became all blood (bright red) mixed with water. This occured twice and then I called doctors office and the dr on call advised me to go to ER since urgent cares were closed. I went to ER about 8:30pm with continued headache, nausea, lightheadedness. I tried to tell ER dr that I was there mainly for throwing up blood. I sat in waiting room. ER dr saw me at 3am and gave me Zofran for nausea as i thought I was going to be sick and gave me EKG, Blood panel and Blood Pressure readings. Told me I was mildly dehydrated. My BP was higher than I think I have ever seen it.
44 2021-02-28 pallor Severe body aches started at 4:00am, could not get comfortable. Only thing that helped aches was the... Read more
Severe body aches started at 4:00am, could not get comfortable. Only thing that helped aches was the bath tub. Didn?t take temperature until 9:00am 100.9. Husband gave me Advil & Tylenol. Stomach ache/nausea came next, didn?t feel like eating. Very painful back ache shortly after that. Temperature kept fluctuating all day (due to Tylenol use). The next day (today 3-1-2021), I felt better, so I went to work. I noticed all day I getting the cold sweats. I was clammy most of the day, but didn?t feel tired. Took temperature after someone noticed I looked pale at work. My temp was 99.7. At around 4:30 I noticed my left armpit was hurting. Went home at 5:30 and relaxed. I told my husband my armpit was hurting around 10:30pm, I decided to Take my temp at 11:15pm and it was 97.6. I will see if the adverse side affects go away after today.
44 2021-03-02 hypertension, fast heart rate Severe anaphylaxis attack; feeling tired; tachycardia; tingling sensation; sweating; feeling hot; BP... Read more
Severe anaphylaxis attack; feeling tired; tachycardia; tingling sensation; sweating; feeling hot; BP = 180/120/her BP was high; feeling lightheaded; This is a spontaneous report from a contactable healthcare professional (HCP) (patient). A 44-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection; lot: EN6201, expiry: Jun2021), intramuscular (IM) on left (L) arm (at the age of 44years) on 16Feb2021 at 12:00 at single dose for COVID-19 immunization. The patient received first dose of bnt162b2 (lot: EN5318, expiry: Jun2021) IM on L arm on 28Jan2021 at 14:45 that 45 minutes after administration (on 28Jan2021) the patient experienced tingling sensation on lip which was with diphenhydramine hydrochloride (BENADRYL) as treatment and recovered on unspecified date. Medical history included hypertension, allergic to fish (treatment were adrenaline (EPIPEN), corticosteroid and antihistamine) and ongoing BP. Concomitant medications included ongoing hydrochlorothiazide, lisinopril (LISINOPRIL + HIDROCLOROTIAZIDA) and ongoing unspecified Vitamins daily. The patient previously took prochlorperazine maleate (COMPAZINE) and metoclopramide (REGLAN) which were medications she took while pregnancy, gabapentin and hydromorphone hydrochloride (DILAUDID) where the patient experienced allergies from these drugs and treatment were adrenaline (EPIPEN), corticosteroid and antihistamine. There was no covid prior vaccination and was covid tested post vaccination with Nasal Swab (Sofia SARS Antigen) on 04Feb2021 with result of negative. The patient experienced severe anaphylaxis attack on 16Feb2021 at 12:30 (30 minutes after the administration of 2nd dose) which resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event) with treatment included Intravenous IV diphenhydramine hydrochloride (BENADRYL) + prednisone + famotidine (PEPCID), GI cocktail, Heart monitoring. The HCP (patient) was on observation for 30 minutes when she started with tingling sensation, sweating and feeling hot (in Feb2021). They took BP=180/120 (in Feb2021). They administered IV diphenhydramine hydrochloride + prednisone + famotidine. She was feeling lightheaded (in Feb2021). She stayed in observation for 4 hours until recovered. She was sent home and prescribed prednisone and loratadine (CLARITIN) daily. HCP stated that she has an episode yesterday (16Feb2021), she was feeling tired, the sweating came back and her BP was high. Today (19Feb2021) her BP was stable. The patient reported tachycardia under information on organ involvement (in Feb2021). The patient required medical intervention but not hospitalized nor admitted to an intensive care unit. No other vaccine in four weeks and no other medications in two weeks. The patient did not receive any recent vaccines for any other conditions prior to the events and did not receive any recent vaccines for SARS-CoV2 other than Pfizer-BioNTech COVID-19 Vaccine prior to the events. The outcome was recovered for the events anaphylaxis and dizziness both in Feb2021, and hypertension on 19Feb2021 while for the remaining events was unknown.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Anaphylaxis cannot be excluded. The case will be reassessed if additional information becomes available.
44 2021-03-02 fast heart rate, hypertension Symptoms were: general allergic reaction with hives followed by a seizure and spontaneous recovery. ... Read more
Symptoms were: general allergic reaction with hives followed by a seizure and spontaneous recovery. Pt relates Seizure was consistent with her normal seizures but slightly worse. She had a seizure 1 week ago and has seizures in clusters, this was consistent with the waning period of the current cluster. Vital signs were (abnormal with tachycardia and hypertension on arrival to the ED). Exam was notable for neck pain. Patient was treated with Benadryl on scene and with Toradol and fluids in the ED and symptoms recovered but multiple shaking episodes characterized by patient as seizure. Patient was observed in the emergency department for an extended period.
44 2021-03-02 blood clot, chest pain, heart attack, troponin increased very high Troponin levels (4.79 & 12.49); repeat episodes of chest pain; heart attack; thrombus form... Read more
very high Troponin levels (4.79 & 12.49); repeat episodes of chest pain; heart attack; thrombus formation; coagulopathy; myocardial infarction; This is a spontaneous report from a contactable nurse (reporting for herself). A 44-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# ELI283), via an unspecified route of administration single dose on 12Jan2021 for covid-19 immunisation. First dose was received on 22Dec2020 10:00 left arm (lot# EJI695). Medical history included chronic skin condition. No other vaccine was received in four weeks. Concomitant medications included oxycodone for pain, colecalciferol (VITAMIN D). The patient experienced myocardial infarction on 10Feb2021 20:00, very high troponin levels (4.79 & 12.49) on 11Feb2021, repeat episodes of chest pain on 10Feb2021 20:00, heart attack on 10Feb2021 20:00, thrombus formation on 10Feb2021 20:00, coagulopathy on 10Feb2021 20:00. The patient was hospitalized due to the events from 11Feb2021. Patient reported to be a healthy 44 year old woman with no history of hypertension or high cholesterol. She was now on 7 different medications to protect her heart, including blood thinners and antihypertensives that result in daily headaches and fatigue. She had had several repeat episodes of chest pain which has required taking sublingual nitroglycerin. She was off work for an undetermined amount of time. Her primary care physician was baffled by her case and reached out to a number of experts who have agreed that her heart attack was caused by a thrombus formation/coagulopathy most definitely related to the Covid vaccines she received. The events outcome was recovered with sequelae.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported event of myocardial infarction and other events. However, the reported events may possibly represent intercurrent medical conditions in this 44-years-old patient. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including EKG at baseline and during subject drug therapy, echocardiogram, electrolytes, chemistry panel and coronary angiogram, and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
44 2021-03-03 chest discomfort Asthma Attack 5 and a half hours after vaccine. Wheezing and tightness. Took Bendadryl and used inh... Read more
Asthma Attack 5 and a half hours after vaccine. Wheezing and tightness. Took Bendadryl and used inhailers and asthma attack stopped.
44 2021-03-09 heart rate increased Flushed; over heated; rash/hives on chest; rash/hives on chest; dry mouth; swollen tongue; rapid hea... Read more
Flushed; over heated; rash/hives on chest; rash/hives on chest; dry mouth; swollen tongue; rapid heart rate; nausea; headache; weakness; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9261), via an unspecified route of administration on 21Jan2021 at 16:00 at a single dose in the left arm for COVID-19 immunization. Medical history included seasonal allergies, some environmental allergies, some heart issues specified as SVT, slight asthma, and lung damage. Prior to vaccination, the patient was diagnosed with COVID-19 on 26Dec2020 (also reported as possibly had COVID in Mar2020, however no tests were available; patient was told to quarantine). On 31Dec2020, COVID-19 test showed a positive result. The patient recovered on 09Jan2021, two weeks from onset of symptoms. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and was not pregnant at the time of vaccination. On 21Jan2021 at 16:15, the patient experienced the following adverse events: flushed, over heated, rash/hives on chest, dry mouth, swollen tongue, rapid heart rate, nausea, headache, and weakness. The events resulted to emergency room visit and doctor office visit. The patient received two epi shots, allergy and anti-nausea medications as treatment for the events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered on an unspecified date.
44 2021-03-10 lightheadedness Headache; general weakness, in her legs especially; No energy; No appetite; Diarrhea; Green colored ... Read more
Headache; general weakness, in her legs especially; No energy; No appetite; Diarrhea; Green colored stools; Very faint/thought she was going to pass out; Eyes were watering; blotches on her neck and chest; tingly experience on her tongue and lips; Severely shaking; Overwhelming chills; Extreme nausea; This is a spontaneous report from a contactable consumer (patient). This 44-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: E19266) via intramuscular at single dose on 20Feb2021 09:30 for COVID-19 immunization. The first dose was on 30Jan2021 in left arm. Medical history included splenectomy from Feb2017; pancreatic surgery from Feb2017, they removed her spleen as part of that; soy allergy; poultry allergy. Patient confirmed she had splenectomy. The surgery was sort of emergency based so knowing most likely they were taking her spleen out; she was given 4 vaccinations. In the hospital, she did break out in what appeared to be like a chicken pox type rash. The rash lasted a month and then it started to fade. She did not have any breathing sort of symptoms. The doctors did attribute the rash to one of the vaccinations, she was not clear on what vaccine caused the reaction. Ideally, she was supposed to have 2 weeks prior to the surgery so her body had time to reabsorb but she did not have that kind of time, but she had nothing internally going on. She confirmed she had no names, NDC, Lot number or expiration dates for the vaccines she received at that point in time. Having the splenectomy was the biggest thing. In the past, she did not have any allergies to medications, but did have allergies to soy and poultry. She did break out from certain food and her skin develops those blotches. She did have an extra work up in Feb2020, where they tested a bunch of food sensitivities and allergies, and nothing came back. This was right before COVID hit so she did not really follow back up after that, but she was tested for all major foods and household things and nothing came up. In her late 20's, she definitely tested for a soy allergy and allergy to poultry. She did check off yes, she had a reaction previously when she was filling out the form at the COVID-19 vaccine site knowing that she had this prior experience. She was held 30 minutes each time for that reason. Concomitant medication was none. Prior vaccinations (within 4 weeks) was no. On 20Feb2021, patient was very faint, thought she was going to pass out, eyes were watering, blotches on her neck and chest, tingly experience on her tongue and lips, severely shaking, overwhelming chills, extreme nausea. On an unspecified date, patient experienced headache, general weakness, in her legs especially, no energy, no appetite, chills that come and go, diarrhea and green colored stools. Patient received her second shot of Pfizer's vaccine on 20Feb2021. She had had symptoms ever since. She had a reaction on site at the vaccine center. She eventually had to go to the Emergency Room by ambulance. Her symptoms were still going on and tomorrow would mark a week since she received the second dose. The symptoms she experienced on site were different than what she was currently experiencing. She felt like she had a true reaction at the vaccine facility site. Within 6 minutes of receiving the second vaccine, she became very faint, her eyes were watering. She thought she was going to pass out for a bit. She was told she had blotches on her neck and chest. She had a tingly experience on her tongue and lips. She was severely shaking and had overwhelming chills. She stated this happened for a couple of hours. Basically, there were 3 waves of these symptoms kind of happening. The third wave happened probably a couple hours after receiving the vaccine. At that point, she had been given two pills of diphenhydramine hydrochloride (BENADRYL), taken orally. With the third wave, she thought she was going to pass out, which she thought multiple times before, but then with this particular wave, she experienced extreme nausea which was kind of a new symptom. The doctor on site said to the EMT that he wanted her to go to the Emergency Room. Patient confirmed she was taken to the ER via ambulance the day she received the vaccine, 20Feb2021. She was never admitted into the hospital; she was only seen in the Emergency Room for a couple of hours. She was given IV fluids, she had blood work done. She didn't have a copy of her labs but she was told they were okay. She was injected with diphenhydramine hydrochloride (BENADRYL) via IV before she was released. A lot more symptoms came after she was released from the hospital (ER). She came home and she had just a crazy headache that she really woke up with every single day until this morning. She had been taking a lot of caffeine/paracetamol (EXCEDRIN, Lot#: H044G, Expiry Date: Jun2022) for her headaches. She experienced extreme weakness, nausea. She clarified she had weakness in her legs. She had this exhaustion, and she felt this general weakness sort of in her legs especially. She was still taking stuff for a headache, and she was taking nausea pills. She had been out of work all week. She had no energy, no appetite really. She had chills that come and go. She had diarrhea. She clarified she had more diarrhea in the beginning days after receiving the vaccine, but it was always been a green colored stool as well. The ER called and checked in and were very surprised she had been having the symptoms still so severely. They wanted her to go get an actual COVID test. She went to the Urgent Care to get COVID tested on 23Feb2021 and had a rapid and PCR test. The rapid test came back negative. She had not received the results for the PCR test yet. She was taking diphenhydramine hydrochloride but she stopped taking that. The hospital directed her stop taking the diphenhydramine hydrochloride earlier in the week. She clarified she was taking a generic version (Lot#: P113966, Expiry Date: Feb2021), coated mini tablets. She clarified the nausea pills she had been taking was the generic for ZOFRAN, ondansetron 4 mg tablet, by mouth, every 8 hours. She confirmed this product was dispensed in a pharmacy bottle with no NDC, Lot number or expiry date on it. She clarified she also had been taking the generic version of TYLENOL EXTRA STRENGTH, it was the Up and Up Brand acetaminophen (Lot#: P122699, Expiry Date: Nov2022) gel caps, 500mg. COVID-19 rapid test was negative on 23Feb2021; COVID-19 PCR test on 23Feb2021 was unknown results. Patient asked if there was a hotline she can call or an information number where she can talk to somebody about her symptoms. She also reported this to her doctor but the doctor made it clear since it was a private practice, they had limited information. The doctor did take down similar information, she just did not know if there was any further information or a hotline she could call. The outcome of events was unknown.
44 2021-03-11 loss of consciousness dizziness on the verge of passing out; welts all over midsection from upper legs through hips and on... Read more
dizziness on the verge of passing out; welts all over midsection from upper legs through hips and onto torso lasting for weeks; Intense headache; dizziness on the verge of passing out; flushed face and ears; This is a spontaneous report from a non-contactable other healthcare professional. This 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL1283), dose 1, single dose via an intramuscular route of administration in the left arm on 10Feb2021 at 10:30 AM (at the age of 44- years-old) for COVID-19 vaccination. Medical history included complete thyroidectomy with neck dissection (removed lymph) for papillary thyroid cancer with neck dissection (removed lymph) for papillary thyroid cancer- otherwise healthy and penicillin allergy. The patient was tested for COVID-19 on 14Aug2020 by nasal swab and was negative. The patient was not pregnant. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine sodium (SYNTHROID). The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 10Feb2021 at 10:30 AM, the patient experienced intense headache within 5 minutes, dizziness on the verge of passing out (waited in the lobby for 1 hour before leaving), flushed face and ears, headache for several days, welts all over midsection from upper legs through hips and onto torso lasting for weeks. The clinical outcome of headache, dizziness on the verge of passing out, flushed face and ears, headache and welts was unknown. No follow-up attempts are possible. No further information is expected.
44 2021-03-23 loss of consciousness Dizzy; Lost all the strength in her arms and legs; Passed out; Nauseous; She dropped to her left whe... Read more
Dizzy; Lost all the strength in her arms and legs; Passed out; Nauseous; She dropped to her left when she passed out and fell in shower; Ear completely clogged up only on the left side; Headache; Tired; Soreness on my arm; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided), via an unspecified route of administration on 07Mar2021 at 11:00 at single dose for COVID-19 immunization. Medical history included underactive thyroid. Concomitant medication included unspecified thyroid medication. The patient was asking if her symptoms were normal following the vaccination. She got the second dose of the COVID vaccine yesterday, 07Mar2021 at around 11:00 (also reported as 10:00 to 10: 15 or 10:30). Throughout the day, she was fine and mentioned that she had soreness on her arm later. At around 22:00, she was driving home and started feeling a slight headache and reported that she didn't take anything. She was tired, so when she got home, the patient fell asleep. She woke up and did feel a slight headache and couldn't sleep on her left arm because it was killing her, but it was fine. At 5:30 this morning (08Mar2021), the headache was still there. She then stood and sat up, took her thyroid pill because she has an underactive thyroid and was on the highest dose of thyroid replacement. The patient stated that the events happened so fast, as soon as she got into the shower. She got out of bed and started walking, grabbed her stuff to shower and started feeling that her headache was building up more than it had all morning so far. She thought maybe it was just because she had just physically gotten up and started walking. She got into the shower, and for about 2-3 minutes into getting into the shower, she remembered she had started putting shampoo into her hands; grabbing the shampoo bottle; but she suddenly got so nauseous and the headache that came on was extreme. She did not have a lot of time to react. She thought she would throw up in the shower, she had no time to get out of the shower to the toilet to throw up; she suddenly felt dizzy, passed out in the shower and fell to her left side on the floor. All she could remember before she passed out was that she had the shampoo bottle in her hands and she said out loud, she heard herself say "What is happening to me". Then she lost all the strength in her arms and legs. She remembered for a split second she tried to hold on, she dropped the shampoo bottle on the floor and grabbed the rail or edge of the shower and tried to hold on because she felt herself when she went down. Her left ear was completely clogged up only on the left side. When she passed out, thankfully she thought by trying to hold on to the rail or edge of the shower that she kind of eased her fall down, so she did not fall hard or hit her head. She did not know if she passed out for seconds or minutes because she has no idea exactly when she went into the shower, maybe around 05:45; but when she woke up she realized she was on the floor, she was not flat on the floor but on her knees, having fallen to the left side with her head off to the side on the shower wall; the glass door to her shower was wide open and all the water was coming out of the shower; it scared her when she woke up. The outcome of the event passed out was recovered on 08Mar2021, not recovered for headache, and unknown for all other events. Information on the lot/batch number has been requested.
44 2021-03-24 palpitations Immediately felt tingling, got shaky and nauseous; Immediately felt tingling, got shaky and nauseous... Read more
Immediately felt tingling, got shaky and nauseous; Immediately felt tingling, got shaky and nauseous; Immediately felt tingling, got shaky and nauseous/shakes; Immediately felt tingling, got shaky and nauseous; hard time swallowing and couldn't breathe right; hard time swallowing and couldn't breathe right; Waves of heart racing; her left leg and arm, her right leg had pins and needles and loss of feeling; wheezing; This is a spontaneous report from a contactable consumer. A 44-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 17Mar2021 09:30 (Batch/Lot Number: ER8727) as single dose for covid-19 immunisation. Medical history included none. No other vaccine in four weeks. No other medications in two weeks. No COVID prior vaccination. Patient experienced immediately felt tingling, got shaky and nauseous. It was coming in waves. she was having a hard time swallowing and couldn't breathe right. She was in the holding. For 15 minutes and she received dismissed annoyed no help from an EMT working in the waiting area for effects. She left. Got a mile down the road and called 911 she was unable to get enough oxygen in. The ambulance arrived and immediately gave her epinephrine, Benadryl, and a breathing treatment along with other medications. She arrived at the hospital and she was doing better and they kept her for observation. She was feeling fine, left with an Epipen and prednisone. The next day (18Mar2021) she felt great until the night time she started wheezing again. She woke up on Friday (19Mar2021). Having shakes and hard time breathing and waves of heart racing. she made a doctor's appointment and received a inhaler. Her symptoms were not getting better and she took Benadryl which helped. By that night her left leg and arm, her right leg had pins and needles and loss of feeling. Treatment included Epinephrine, Benadryl, Prednisone, Albuterol. No COVID tested post vaccination. Events immediately felt tingling, got shaky and nauseous, swallowing and couldn't breathe right required clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness. Outcome of immediately felt tingling, got shaky and nauseous, swallowing and couldn't breathe right was recovering.
44 2021-03-25 chest discomfort Anaphylaxis: Shortness of breath, chest tightness, itching, muscle spasm
44 2021-03-26 haemoglobin decreased, blood glucose increased She received the first dose of the Pfizer COVID-19 vaccine on 3/25, and had some lip and tongue swel... Read more
She received the first dose of the Pfizer COVID-19 vaccine on 3/25, and had some lip and tongue swelling and vocal changes with wheezing within 15 minutes of receiving the vaccine. She was treated with benadryl and albuterol and sent home after improvement. After going home, continued to have some lip/throat swelling. She then presented to local hospital with worsened symptoms, treated with benadryl and steroids, given a script for prednisone, and sent home. She did not fill the prednisone script initially, but had some prednisone (unknown strength) at home and took a pill. The following morning (3/26), she continued to have throat and lip swelling and began to develop some dyspnea. Due to these worsening symptoms, she came to ED. She received a total of 5 doses of IM epinephrine (1734, 1938, 2010, 2320, 0017) along with IV pepcid and IV solumedrol for persistent subjective throat swelling, dyspnea, and difficulty tolerating secretions. She was admitted to the ICU for close monitoring of symptoms and consideration of an epinephrine drip, but did NOT require this. In the morning of 3/27, she noted substantial improvement in symptoms of tongue/lip swelling, improved wheezing, dyspnea, and dysphagia. Still with some mild hoarseness that she attributes to cough, also improving.
44 2021-03-28 fast heart rate 3/25/2021-pt states that about 10-15 minutes after taking the covid vax her throat was tight and she... Read more
3/25/2021-pt states that about 10-15 minutes after taking the covid vax her throat was tight and she was wasn't feeling right. About an one hour and ten minutes she went into anaphylaxis shock. Paramedics were called. Pt had a seizure while in transport to the Hospital ER. She was given an EKG in ambulance w/ abnormal results that showed tachycardia and abnormal ECG. Vent rate was 48 beats faster per minute, no spectral infarct detected. When came to she was having seizure like muscle spasms all her entire body. In the ER she was given meds and monitored for 4 hours before being released to home. 3/26/2021- Next day her skin, her eyes, and the inside of her body felt like it was boiling. She went back to the same ER. She was given another EKG which show possible left atrial enlargement and spectral infarct age undetermined - Abnormal ECG when compared to the ECG on 3/25/201. She blood work and Chest Ray. She was given more meds and told to FU w/ PCP. Her appt w/ PCP is on 3/29/21 and will be determined if she needs to see Cardiologist.
44 2021-04-01 fast heart rate EKG changes (ST depression); I started feeling short of breath; tachycardia; fatigue; upper back/lef... Read more
EKG changes (ST depression); I started feeling short of breath; tachycardia; fatigue; upper back/left scapula pain; upper back/left scapula pain; This is a spontaneous report from a contactable Physician (patient herself). A 44-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 2 via an unspecified route of administration, administered in the left arm at age 44 years on 27Jan2021 15:00 (Batch/Lot Number: EL3246) as single dose for COVID-19 immunization. Medical history included alopecia and known allergies to peanuts. Patient is not pregnant. Patient had not had COVID prior vaccination. Concomitant medication(s) included ethinylestradiol, norgestimate (ORTHO TRI-CYCLEN), spironolactone, VIT D, zinc, and biotin, taken on unspecified dates for an unspecified indication. Patient previously took dose 1 of BNT162B2 lot number= EL3246 on 08Jan2021 with administration time at 04:15 pm, vaccine location on the left arm. On 29Jan2021, 2 days after the vaccine, patient started feeling short of breath, tachycardia, fatigue, and upper back/left scapula pain. Patient thought she had some side effect that eventually would go away. By 02Feb2021, she felt worsening tachycardia, fatigue and shortness of breath. Patient went to (Hospital name withheld) and they did a COVID 19 test on Feb2021. The test was negative but they found that she was very tachycardic and EKG changes (ST depression). Then, patient underwent a cardiac catheterism and a CT angio of the chest and both were negative. Patient was discharged 24 hours later still tachycardic up to are of 110s. As outpatient, patient underwent echocardiogram and was negative as well. Patient saw her cardiologist on 19Mar2021 and it seems that the tachycardia resolved along with her fatigue and upper back pain. All these symptoms gradually improve over time. She still have the ST depressions on her EKG but she was asymptomatic. No one was sure if she had any sort of immunologic reaction to the vaccine. AE resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care and hospitalization. Treatment was heparin, aspirin and ticagrelor (BRILINTA). The outcome of the event EKG changes (ST depression) was not recovered, while for the rest of the events, it was recovered on 2021.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
44 2021-04-06 palpitations dizzy; throat started to swell; Within five minutes of the immunization my heart was racing; This is... Read more
dizzy; throat started to swell; Within five minutes of the immunization my heart was racing; This is a spontaneous report from a contactable healthcare professional (patient). A 44-year-old female patient received BNT162B2 (lot number and expiry date were not reported), via an unspecified route of administration, administered in right arm on 18Dec2020 09:00 (at the age of 44-year-old) at single dose for COVID-19 immunization. Medical history included dairy allergy. The patient is not pregnant at the time of vaccination. The patient's concomitant medications were not reported. No other vaccines within 4 weeks prior to the COVID vaccine nor any other medications the patient received within 2 weeks. Within five minutes of the immunization on 18Dec2020 the patient's heart was racing, she was dizzy, her throat started to swell, and she was brought to the ER where they gave her epinephrine and Benadryl. She was admitted to the hospital (Dec2020) two times within a week due to the same symptoms; continuous heart palpitations. She was still having heart palpitations. The adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage. The patient was hospitalized for 5 days. Since the vaccination, has the patient been tested for COVID-19. Covid test was negative on unspecified date. The outcome of the event heart was racing was not recovered and the outcome of the remaining events was recovering. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events palpitations, dizziness and pharyngeal swelling occurred in a plausible temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
44 2021-04-09 palpitations, heart rate increased About 4 hours after the first vaccine, numbness and tingling all over the body. Left arm went comple... Read more
About 4 hours after the first vaccine, numbness and tingling all over the body. Left arm went completely numb and tingling. Scalp tingling and numb. Felt like circulation was cut off. Severe Shortness of breath. Extreme feeling of adrenaline. The next day on March 14th, had extreme vaginal bleeding on day 14 of cycle. Bled for another 7 days which led to extreme anemia. The shortness of breath is every day since the first dose. Heart palpitations (heart rate went up to 190!). After the second dose on 4/03, all symptoms got worst. Left leg went completely numb the same day which I went to the emergency room for. The neurological tingling and numbness was spreading to my whole body. Arms, legs, face, ears, scalp, inside my head. I was worried for a heart attack since all of my symptoms of left arm and shoulder pain and numbness etc. I was released from the emergency room 12 hours later. I continued to have severe symptoms. The shortness of breath was so bad that I didn't sleep for 2 nights straight because my oxygen would drop. I also had severe insomnia and no appetite and lost 5 pounds in 1 week. Major adrenaline feeling. I went back to the emergency room 2 more times this week to check out my heart and lungs. All of my doctors recommended ER since they couldn't help me. My neurologist said he is getting lots of these symptoms from people post vaccine. My shortness of breath and elevated heart rate and numbness and tingling are still here and I can barely go up and down stairs without being out of breath and having a 130-140 heart rate and super low blood pressure and night sweats. It is awful.
44 2021-04-09 fainting I fainted; I was disoriented and the room was spinning.; I was disoriented and the room was spinning... Read more
I fainted; I was disoriented and the room was spinning.; I was disoriented and the room was spinning.; extremely nauseated; This is a spontaneous report from a contactable consumer (patient herself). A 44-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via unknown route of administration on 24Mar2021 at single dose in left arm for COVID-19 immunization. Medical history included Cancer. No known allergies. No covid prior vaccination. Patient was not pregnant at time of vaccination. Concomitant medication in two weeks included letrozole. No other vaccine in four weeks. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunization. It was reported that when patient woke up in the middle of the night. Patient was disoriented and the room was spinning. patient fainted and then was extremely nauseated all on 25Mar2021 02:00 AM. No treatment for adverse events. No covid tested post vaccination. The outcome of events was recovering. Information about lot/batch number has been requested.
44 2021-04-09 blood clot, pulmonary embolism Pulmonary Embolism. Emergency open heart surgery. Coded for 4 minutes. In ICU and Hospital. Kidney f... Read more
Pulmonary Embolism. Emergency open heart surgery. Coded for 4 minutes. In ICU and Hospital. Kidney failure.....Total blockage of left lung. 9 inch clot in right ventricle.
44 2021-04-09 chest pain, low platelet count nausea; vomiting; chest pain; myocarditis; thrombocytopenia; This is a Literature-spontaneous report... Read more
nausea; vomiting; chest pain; myocarditis; thrombocytopenia; This is a Literature-spontaneous report 2021, 1-4; entitled Thrombocytopenia following Pfizer and Moderna SARS-CoV-2 vaccination. A 44-year-old woman was hospitalized for nausea, vomiting and chest pain on the day that she received the Pfizer vaccine (BNT162B2) via an unspecified route of administration on an unspecified date (Batch/Lot number unknown) at single dose (at 44-year-old) for COVID-19 immunization. Her laboratory values included a platelet count of 85 x 109/L and a peak troponin level of 4 ng/mL (normal < = 0.04 ng/mL). The patient was diagnosed with myocarditis but did not require treatment for thrombocytopenia. Her platelets were 61 x 109/L on discharge, but subsequent platelet counts were not reported. The outcome of the events was unknown. No follow-up attempts are needed. Information on Lot/batch number cannot be obtained.; Sender's Comments: The causal association cannot be excluded between the reported events and BNT162B2 vaccine use. The impact of this report on the benefit-risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for AE. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, ethics committees and investigators, as appropriate.
44 2021-04-12 loss of consciousness Was not instructed to wait after shot so I went to my car. Drove for a couple of hours. Got out of c... Read more
Was not instructed to wait after shot so I went to my car. Drove for a couple of hours. Got out of car, walked forward and passed out with a seizure then throwing up when I came to. Received concussion. Taken to ER and admitted for 5 days. Still experiencing vertigo and nausea
44 2021-04-14 chest discomfort Immediate dizziness upon injection; Upon moving to observation (1-2 minutes), I again had chest/thro... Read more
Immediate dizziness upon injection; Upon moving to observation (1-2 minutes), I again had chest/throat tightness and shortness of breath. Within 5-10 minutes, I began to experience facial numbness; All of these adverse reactions continued for a few hours post-vaccine
44 2021-04-17 blood clot, pulmonary embolism massive clots; Pulmonary Embolisms; Occluded Left Lung, Right Ventricle; Occluded Left Lung, Right V... Read more
massive clots; Pulmonary Embolisms; Occluded Left Lung, Right Ventricle; Occluded Left Lung, Right Ventricle; This is a spontaneous report from a contactable consumer (parent). A 44-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported) via an unspecified route of administration administered in the right arm on 15Mar2021 13:45 as a single dose for COVID-19 immunisation. Medical history included multiple sclerosis. The patient is not pregnant at the time of vaccination. The patient has no known allergies and has not had COVID prior to vaccination. Concomitant medications included gabapentin, carbamazepine (TEGRETOL), fluoxetine, colecalciferol (VITAMIN D), fish oil, and baclofen. The patient did not receive any other vaccine in 4 weeks prior to the COVID vaccine. On 30Mar2021 06:00, the patient experienced Pulmonary Embolisms, Occluded Left Lung, Right Ventricle and had emergency open heart surgery to remove massive clots. He coded for 4 minutes and was in ICU for 9 days. The patient was hospitalized due to the events on an unspecified date for 12 days. The events resulted in Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event), and Disability or permanent damage. Treatment for the events included open heart surgery. The patient underwent COVID test post vaccination via nasal swab on an unspecified date with unknown results. The outcome of the events was recovered with sequelae on an unspecified date. Information about lot/batch number has been requested.
44 2021-04-21 nosebleed, loss of consciousness On April 4th at approximately 8:00am, I blacked out while I was walking to use the restroom, and lan... Read more
On April 4th at approximately 8:00am, I blacked out while I was walking to use the restroom, and landed face first on the kitchen floor. When I came to, my nose was bleeding and my right arm was numb. My husband called my doctor (and spoke with the doctor on call) who told me to go to the ER. While at the ER, the doctor ran an EKG, CT, and labs. All tests came back fine. I have had a headache, neck pain, and have felt light headed ever since. I returned to the ER a week later with a severe headache. Another CT, EKG, and chest x-ray. All results were fine. I have also seen a neurologist and a cardiologists. All tests came back fine. I still have a constant headache and feel light headed.
44 2021-04-24 fainting PMS symptoms; nipples became very hard and sore.; swollen breast tissue; Menses late and hasn't star... Read more
PMS symptoms; nipples became very hard and sore.; swollen breast tissue; Menses late and hasn't started; symmetrical lumps on the distal sides of my breasts; faint; slight injection site soreness; intense tingly whole body sensations; Sense of pressure and tingling on eyeballs; Increased sensitivity to touch; This is a spontaneous report from a contactable healthcare professional (patient). A 44-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 30Mar2021 16:00 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included Mild/moderate TBI in Oct1999 with herniated disk in lower lumbar region from auto accident (patient was a pedestrian and a car ran into her); fractured tibia/fibula from occurrence; low blood pressure which she had occasionally fainted from at blood draws (started after being active athletically during recovery from 1999 injury). Patient was not pregnant. There were no concomitant medications (no vaccine in 4 weeks and no other medication in two weeks). Patient did faint 15 minutes after receiving Pfizer Covid vaccine on 30Mar2021. Medical people at vaccination site made a vasovagal note on record. Patient reported that there were no body aches or fatigue or fever, only slight injection site soreness for a couple of days which was hard to notice through intense tingly whole body sensations that started after receiving vaccine on 30Mar2021 16:15. Still continuing to feel a week and a half later. It was very uncomfortable but not painful. Patient also experienced sense of pressure and tingling on eyeballs and increased sensitivity to touch. Menses were due one week after vaccination but 4.5 days after vaccination on 03Apr2021, nipples became very hard and sore. After a few days on nipples slightly sore still but mostly swollen breast tissue with soreness on Apr2021. Patient had not had this as PMS symptom since becoming pregnant almost 9 years ago and it never lasted 7.5 days with it still ongoing as of time of report. Her menses was late on Apr2021 and hasn't started but she was not pregnant. Patient's usual PMS symptoms have kind of started yesterday on 09Apr2021. It quickly formed bilaterally symmetrical lumps on the distal sides of her breasts which was also unusual on Apr2021. No treatment was received and events results in doctor's clinic visit. Outcome of the events was not recovered. Patient was not diagnosed with covid prior to vaccination and had not been tested post vaccination. Information on the lot/batch number has been requested.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event syncope and the suspect suspect vaccine BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
44 2021-04-24 nosebleed causing burst blood vessels in face, eyes, nose and throat; causing burst blood vessels in face, eye... Read more
causing burst blood vessels in face, eyes, nose and throat; causing burst blood vessels in face, eyes, nose and throat; causing burst blood vessels in face, eyes, nose and throat; causing burst blood vessels in face, eyes, nose and throat; Nausea; repeated vomiting; This is a spontaneous report from a contactable consumer (reporting for herself). A 44-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 07Apr2021 at 10:15 (Batch/Lot Number: ER 8737) as single dose for COVID-19 immunization. Medical history included drug amoxillin allergy. Concomitant medication included ibuprofen, simeticone (GAS X), cimetidine (TAGAMET [CIMETIDINE]) and colecalciferol (VITAMIN D [COLECALCIFEROL]), all taken for an unspecified indication, start and stop date were not reported. On 07Apr2021 at 23:00, the patient experienced causing burst blood vessels in face, eyes, nose and throat, nausea and repeated vomiting. The outcome of the events was recovering. The patient did not had COVID prior to vaccination and did not tested positive post vaccination. No follow-up attempts are possible. No information is expected.
44 2021-04-28 hypotension, heart rate increased I haven't been able to work since/I can't function; my left leg went completely numb; I couldn't wal... Read more
I haven't been able to work since/I can't function; my left leg went completely numb; I couldn't walk; my immune system attacking the nerves; The shortness of breath is very bad; My pulse is high; My blood pressure is low; I have major neurological symptoms now.; My left eye is now affected too and blurry.; keep feeling my face and now my tongue and mouth go numb; keep feeling my face and now my tongue and mouth go numb; This is a spontaneous report received a contactable other healthcare professional, the patient. This other healthcare professional reported similar events for the same patient with each dose of the same product; this case refers to the second dose. A 44-year-old adult [non-pregnant] female received the second dose of BNT162b2 (solution for injection; Lot unknown expiry information not provided) in the right arm via unspecified route on 03Apr2021 (at 44-years-old), for COVID-19 immunisation. Relevant medical history included thyroid. Concomitant medications included levothyroxine sodium (TIROSINT) for thyroid. The patient previously received COVID-19 immunisation with the first dose of BNT162b2 (Lot unknown expiry information not provided) in the left arm on 13Mar2021 at 12:00 (at 44-years-old) and experienced face, head and ears started tingling, shortness of breath, numbness and weakness, severe burning all over her nerves of her body, and abnormal uterine bleeding. The patient denied any known allergies and being diagnosed with COVID-19 prior to the vaccine. The patient was not pregnant at the time of vaccination and the patient denied receiving any other vaccine within four weeks of this vaccine. The patient reported that on 03Apr2021 she received her second shot and within four hours her left leg went completely numb and she could not walk. The patient reported that she went to the emergency room three times since that time. The patient reported that she was told it was her immune system attacking her nerves. The patient reported that the shortness of breath is very bad, her pulse is high, and her blood pressure is low. The patient explained that she has major neurological symptoms now. The patient stated that she has had two magnetic resonance imaging (MRI), on computerized tomogram (CT) and two x-rays though no results were provided. The patient explained that she has appointments with neurologist and immunologist. She is unable to work since she has to be on video with people and keep feeling my face and now her tongue and mouth go numb. The patient stated that she was scared to eat food, so she does not choke. The patient mentioned that her left eye is affected too and blurry. The patient exclaimed that she cannot function, it is scarring her little kids and has affected her entire family. The patient reported that events resulted in: Doctor or other healthcare professional office/clinic visit; Emergency room/department or urgent care, Hospitalization, Disability or permanent damage]; with hospitalization for three days. The patient has not been tested for COVID-19 since the vaccine. Treatment for the events included intravenous (IV) anti-inflammatory. The outcome of the events left leg went completely numb, could not walk, immune system attacking her nerves, shortness of breath, pulse is high, blood pressure is low, neurological symptoms, unable to work/ cannot function, feeling my face and now her tongue and mouth go numb, and left eye is affected too and blurry, was not recovered. The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.; Sender's Comments: Based on the close temporal relationship, the association between the reported events with BNT162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) :-PFIZER (Same reporter/patient/product, similar events with first dose)
45 2021-01-02 blood glucose increased, palpitations, heart rate increased, blood pressure increased After the shot I sat down and waited for 15 minutes and about 12 minutes a felt flushed and my pul... Read more
After the shot I sat down and waited for 15 minutes and about 12 minutes a felt flushed and my pulse went night around 119 beats per minute and my blood pressure went high to 150 over 99 .. my sugar jumped to 149 and I got so clammy .. it lasted a good 25 minutes I kept checking my o2 and my pulse finally it went down and I was so tired.. I went home and I was fatigue for 5 days .. I don?t know if I should get the second dose after my heart raced
45 2021-01-02 lightheadedness Severe vertigo began at 3:00 PM on 12/31/2020. Vomiting lasting approx. 9 hours (8 episodes). Unable... Read more
Severe vertigo began at 3:00 PM on 12/31/2020. Vomiting lasting approx. 9 hours (8 episodes). Unable to open eyes due to vertigo, vasovagal upon standing lasting until approx. 3:00 pm 1/2/2021. Diarrhea began approx. 8:00 pm 1/1/2021 with episodes each time after trying to eat 4 episodes. Headache lasted 3 days. Today on 1/3/2021 I have been able to keep down soup. Eyes feel tired, minimal vertigo upon moving head. No further diarrhea, vomiting.
45 2021-01-03 chest discomfort, chest pain After leaving 15 minute post vaccine period, employee felt pins and needles developing on left arm a... Read more
After leaving 15 minute post vaccine period, employee felt pins and needles developing on left arm and leg for 20 minutes but neck and face numbness continued 12/25-12/27. Continued with facial numbness on 12/26. Called Occupational Health on 12/28 and stated that she had thigh numbness, no other Covid symptoms. Sent for testing and was negative. On follow up on 12/29, had fatigue, diarrhea and weakness, and on 1/1 still had thigh numbness and extreme fatigue, no diarrhea. By 1/3/21, had fingertip numbness on left hand, pain on her left arm and chest pressure and burning. Went to ER on 1/3 where she had a full workup for myelitis, MRI, C spine, T spine and brain, CBC, CMP, ESR. Treated with toradol and prednisone in ER and discharged. Currently on 1/4 improved muscle weakness but ongoing fatigue taking four day course of prednisone to follow up with PCP. A second dose of the vaccine scheduled on 1/11/21 will be on hold until PCP clearance. Current diagnosis decompensation of raynauds disease due to vaccine reaction.
45 2021-01-03 chest pain, hypertension, heart rate increased High blood pressure 187/95; Heart rate at one time 210 bpm; chest pain; Shortness of breath; This is... Read more
High blood pressure 187/95; Heart rate at one time 210 bpm; chest pain; Shortness of breath; This is a spontaneous report from a contactable pharmacist (patient) reported for herself that a 45-years-old female patient received first dose of BNT162B2 (lot number: EH9899), via intramuscular in left arm on 22Dec2020 07:00 AM at single dose for COVID-19 immunization. The patient was not pregnant. No known allergies. No allergies to medications, food, or other products. No other vaccine was received within 4 weeks prior to the COVID vaccine. No other medications were received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior vaccination and patient was not tested for COVID-19 since the vaccination. There were no medical history or concomitant medications. The patient experienced high blood pressure 187/95, heart rate at one time 210 bpm, shortness of breath and chest pain on 23Dec2020 10:00 AM. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Treatment was received for heart rate at one time 210 bpm which included lab works and medication given propranolol to decrease heart rate. The outcome of the event was recovering.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events hypertension, heart rate increased, chest pain and dyspnoea cannot be excluded. The information available in this report is limited and this case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
45 2021-01-04 heart rate increased Severe dyspnea, wheezing, heart rate greater than 130
45 2021-01-04 blood pressure increased dizzinessand lightheaded; Vision slightly blurred; BP elevated to 144/96; Slight nausea for remainde... Read more
dizzinessand lightheaded; Vision slightly blurred; BP elevated to 144/96; Slight nausea for remainder of day; This is a spontaneous report from a contactable nurse reporting for herself. A 45-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 23Dec2020 14:00 at a single dose for COVID 19 vaccination. The facility where the most recent COVID-19 vaccine was administered was a hospital. The patient was not pregnant at the time of vaccination. There was no other vaccination administered in the 4 weeks prior to COVID-19 vaccination. Medical history included multiple sclerosis from an unknown date and unknown if ongoing. There were no allergies to medications, food, or other products. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications were not reported; the patient did receive other medications within 2 weeks prior to COVID-19 vaccination.The patient experienced dizziness and lightheaded, noticed about 30 minutes after vaccine. Vision slightly blurred. BP elevated to 144/96. Slight nausea for remainder of day. The events occurred on 23Dec2020 at 14:45 pm. No treatment was received for the events. The patient recovered from the events dizziness, lightheaded, vision slightly blurred, BP elevated to 144/96, and slight nausea on an unknown date in Dec2020. The patient was not COVID-tested post vaccination. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
45 2021-01-05 heart rate decreased, oxygen saturation decreased Patient II, a 45-year-old female with a history of vaccine-related anxiety, presented to the vaccine... Read more
Patient II, a 45-year-old female with a history of vaccine-related anxiety, presented to the vaccine clinic for her second-dose of the pfizer COVID-19 vaccine. Pharmacist then delivered vaccine. Almost immediately after administration, the patient started showing signs of distress including difficulty speaking, and going in an out of consciousness. Ice packs were placed on the back of patient's neck, and she was given water in order to hopes to stimulate consciousness. At this time, the pharmacist placed a pulse oximeter on her finger to monitor. Her oxygen stats dropped to 75% and heart rate dropped to a value slightly greater to slightly under 30 beats per minute as indicated by the pulse ox blinking at 30. Pharmacist timed the period of bradycardia, after 60 seconds an epinephrine pen 0.3mg was administered to the left lateral thigh. Rapid response code was called and team came 1.5 - 2 minutes after epinephrine administration. Oxygen was given to the patient at the scene where her recorded blood pressure was 94/54 mmHg. She was then transported into the emergency department via wheelchair. Patient stabilized and was discharged back to work approximately an hour after arrival.
45 2021-01-05 chest discomfort Patient stated she started having symptoms < 5 minutes after receiving the vaccine (while waiting), ... Read more
Patient stated she started having symptoms < 5 minutes after receiving the vaccine (while waiting), she initially had significant headache (which has now resolved), full-body itching, some throat irritation, and lacrimation. Patient also noticed swelling in her bottom lip. Patient states she's only allergic to pineapple, has never reacted to vaccines before, and states she's never had anaphylaxis before this. She does not carry an Epi pen with her regularly." Patient also had chest tightness, sore-throat/neck muscles. Patient was given Epi, benadryl IV, decadron IV, and bolus fluid. She was monitored for 4 hours and discharged once stable.
45 2021-01-05 fast heart rate next day with headache, nausea, dizziness, tachycardia up to 170 for about 30 minutes. symptoms star... Read more
next day with headache, nausea, dizziness, tachycardia up to 170 for about 30 minutes. symptoms started the morning after the vaccine about 24 hours later and then resolved within that next day.
45 2021-01-06 heart rate increased 12/31/2020: Around 2pm, feeling dizzy and rapid heartbeat. 3:30pm, rapid heartbeat. 6pm rapid heartb... Read more
12/31/2020: Around 2pm, feeling dizzy and rapid heartbeat. 3:30pm, rapid heartbeat. 6pm rapid heartbeat 01/01/2021: 6am, rapid heartbeat. 8pm, rapid heartbeat 01/02/2021: 8am, rapid heartbeat. 2pm, rapid heartbeat 01/03/2021: 1:30pm, rapid heartbeat lasted until around 3pm. 01/04/2021: 7am, rapid heartbeat. around 8pm, rapid heartbeat. 01/05/2021: 10am rapid heartbeat The first two days I experienced the rapid heartbeat, I almost had an anxiety attack but I learned to breath through my nose and I would be okay after that. Today is January 7 and i haven't experienced anything in the last two days.
45 2021-01-06 fainting, heart rate increased, blood pressure increased When patient initially received the vaccination, she complained of mild dizziness. She went home aft... Read more
When patient initially received the vaccination, she complained of mild dizziness. She went home after monitoring and returned to work the PM shift rested. Approximately 45 minutes into the shift, she c/o dizziness. She had elevated BP 209/102 and HR 108 and at one point had a syncopal episode. Emergency services was called and she was transferred to the hospital for further evaluation.
45 2021-01-06 hypertension around 1500 Vomited x 1; HTN 190's/ 116-118; flush cheeks bilaterally; dizzy; weak;
45 2021-01-07 palpitations 06 Jan 2021 @0810: Patient transported to ED following near syncopal episode at desk. Reported dizz... Read more
06 Jan 2021 @0810: Patient transported to ED following near syncopal episode at desk. Reported dizziness/lightheaded, intermittent nausea, and heart beating hard. Patient received vaccine at 0645 hours. Provided IV fluids.
45 2021-01-07 blood pressure increased After receiving the vaccine, pt noted a sensation of pressure on the roof of her mouth, followed by ... Read more
After receiving the vaccine, pt noted a sensation of pressure on the roof of her mouth, followed by a metallic taste. Elevated BP noted. Pt denies SOB and is without rash or angioedema. Pt brough to emergency dept where she reported feeling flushed, nausea, and headache. Given Zofran 4mg ODT and Tylenol 650 mg po. Pt d/c after 2 hours and advised to f/u w/ PCP as needed.
45 2021-01-07 chest discomfort Fever 102.5 x 24 hours at this time. Chills, body aches, headache and fatigue. Some chest discomfort
45 2021-01-07 chest pain, palpitations I started having flushing within a minute of receiving vaccine next I noticed I had heart palpitati... Read more
I started having flushing within a minute of receiving vaccine next I noticed I had heart palpitations I was told my skin was clammy then I had another episode I was taken to ER and decardron was given. I was observed in ER for few hours . Since that day I have heart palpitations every day along with chest pain sometimes I am not able to wean off steroids I also had diarrhea on 1/3 that lasted few days . These side effects are very scary every day heart palpitations I feel my heart would stop
45 2021-01-07 fainting, blood pressure decreased, blood pressure increased PT HAD A VASOVAGAL SYNCOPE EPISODE: ( SWEATING, NAUSEA, AND BLOOD PRESSURE DROPPING). PT WAS LAYED ... Read more
PT HAD A VASOVAGAL SYNCOPE EPISODE: ( SWEATING, NAUSEA, AND BLOOD PRESSURE DROPPING). PT WAS LAYED ON THE FLOOR IN A SUSPINE POSITIION WITH FEET ELEVATED. PT WAS PLACED ON A BLOOD PRESSURE MONITORING MACHINE. COLD COMPRESSIONS WERE APPLIED TO THE PATIENT'S BODY. PT WAS GIVEN A FEW CRACKERS AND SODA TO INCREASE BLOOD SUGAR. WITHIN MINUTES THE PT BLOOD PRESSURE BEGAN TO RISE AND PT FELT FINE. PT WANTED TO DRIVE HOME AND WAS ADVISED NOT TO DRIVE. PT CALLED FOR HER PARENTS TO COME AND PICK HER UP.
45 2021-01-07 chest pain Patient was at work and felt nauseous at around 0800 and took a Zofran. Then around 1030 she started... Read more
Patient was at work and felt nauseous at around 0800 and took a Zofran. Then around 1030 she started to have lower chest (near the lower ribs) pain 9/10 pain and she was diaphoretic. We called 911 as we were concerned about an MI. She was transported via EMS to the hospital. They ran various tests and determined it wasn't cardiac or lung issues and was likely side effects from the COVID vaccine. On 1/8/21, Patient reports that she feels dizzy and is "itching all over." She took antihistamine and that helped the itching symptom.
45 2021-01-07 hypertension, fast heart rate Redness on face, neck, and arms, Tachycardia, HTN
45 2021-01-07 heart rate increased, chest discomfort dizziness, congestion, cough, heart rate elevated, fatigue, injection site pain, chest heaviness neg... Read more
dizziness, congestion, cough, heart rate elevated, fatigue, injection site pain, chest heaviness negative Covid test
45 2021-01-07 heart rate increased, chest discomfort dizziness, congestion, cough, heart rate elevated, fatigue, injection site pain, chest heaviness y n... Read more
dizziness, congestion, cough, heart rate elevated, fatigue, injection site pain, chest heaviness y negative Covid test
45 2021-01-08 blood pressure increased, chest discomfort After 15 minutes patient reported chest pressure which increased with inspiration. could not report... Read more
After 15 minutes patient reported chest pressure which increased with inspiration. could not report rating on pain scale. Initial BP with complaints was 168/138. HR 88, RR 16, 98 o2sat, Temp 98.8. Follow BP 137/85 5 minutes later .Sent to ED at 12:53. 12 lead EKG, Normal sinus rhythm, no ischemia. CXR negative. Shortly upon arrival in ED chest pressure resolved with out further intervention. Pt discharged to home.
45 2021-01-08 lightheadedness Elevated temp 102.3, near syncope x4, chills, joint pain especially in back and neck, nausea 12 hour... Read more
Elevated temp 102.3, near syncope x4, chills, joint pain especially in back and neck, nausea 12 hours, pulse 100, night sweats, dizziness and slight headache after Tylenol
45 2021-01-09 blood pressure increased 1825 Patient reported feeling "Shaky", patient reports having same reaction with first vaccine and w... Read more
1825 Patient reported feeling "Shaky", patient reports having same reaction with first vaccine and was observed in ED for 90 mins, had increased BP at that time that resolved by discharge. 1825 BP 156/101 HR 80 Patient declined ED, food, drink and had a rapid response nurse friend at chairside. assessment repeated at 1840 B/P 136/94 HR 80, 1850 BP 140/100 HR 75 pt. reporting feeling better. Pt. reported feeling much better and left with friend at 1900.
45 2021-01-10 palpitations 45 y.o. female with a hx with asthma, migraine, here for second dose vaccine. C/O feeling shivering,... Read more
45 y.o. female with a hx with asthma, migraine, here for second dose vaccine. C/O feeling shivering, sweaty, and racing heart beats. Similar feelings with the first dose but much more mild. HR reports up to 120s. Check BP 144/109 HR 110 RR 18 --- > BP 135/91, HR 99-100 on discharge at 12:20 pm. Patient rests comfortably and feels a lot better. She has no respiratory complain or cardiac complain on discharge. Walks away without apparent distress. Symptoms resolved
45 2021-01-10 blood pressure increased, heart rate increased Approximately 5 minutes after vaccination, patient began reporting flushing, shortness of breath, di... Read more
Approximately 5 minutes after vaccination, patient began reporting flushing, shortness of breath, difficulty swallowing. Presented with elevated BP, pulse, normal O2. Symptoms came in waves with increasing frequency. Nausea also occurred as symptoms continued. Patient was monitored for ~15 minutes before Epi Pen (.03mg) was administered. Patient was transported to hospital by ambulance.
45 2021-01-10 heart rate decreased, fainting Vasovagel syncope episode - passed out a total of 3 times Drop in pulse ox and heart rate
45 2021-01-10 lightheadedness, heart rate decreased vasovagal episode drop in pulse ox drop in heart rate
45 2021-01-11 chest discomfort Chest tightness, dizziness, chills. No reported treatment and symptoms resolved.
45 2021-01-11 palpitations Got very hot and clammy but at the same time had the goosebumps; Got very hot and clammy but at the ... Read more
Got very hot and clammy but at the same time had the goosebumps; Got very hot and clammy but at the same time had the goosebumps; Got very hot and clammy but at the same time had the goosebumps; My whole body was as if I was sun burnt; My heart started to race; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received BNT162B2, (Pfizer COVID Vaccine, lot number: EK9231, expiry date: Apr2021) intramuscular on an unspecified date at single dose on right arm for COVID-19 immunisation. Medical history included migraine from an unknown date and unknown if ongoing. Concomitant medication included nortriptyline for migraine, botulinum toxin type a (BOTOX) for migraine and birth control medication. The patient stated that, "I was wondering if this was a reaction to the vaccination I had today. So I ended up 3 hours after I received the vaccine, I got very hot and clammy but at the same time had the goosebumps and then my whole body was as if I was sun burnt and my heart started to race. And then my whole body was red as if I had a sunburn. Actually I went to the ER today and they just did lab work because of the way I was feeling. All they gave me in the emergency room is IV fluids." Therapeutic measures taken as a result of the events included IV fluids. The outcome of the events was unknown.
45 2021-01-11 hypertension Pt hypertensive response. BP 148/99, HR 109.
45 2021-01-11 heart rate increased Received Pfizer covid vaccine 1st dose at 1615, c/o lump in throat at 1616, which became worse. Her... Read more
Received Pfizer covid vaccine 1st dose at 1615, c/o lump in throat at 1616, which became worse. Her HR was also in 120's. At 1618, Epi given x1, then pt transferred to ED
45 2021-01-11 chest pain Received shot at 11:35 am Friday 1/8/21. Woke up 1/9/21 with chest pain, in SVT HR 140s-180s, persis... Read more
Received shot at 11:35 am Friday 1/8/21. Woke up 1/9/21 with chest pain, in SVT HR 140s-180s, persisting for 8+ hours until treated by cardiologist with addition of Flecainide. Flecainide 50 mg twice daily now part of medications.
45 2021-01-12 chest discomfort At 9 pm- I exhibited chills labs body aches. At 3 am I had difficulty swallowing and a swollen neck.... Read more
At 9 pm- I exhibited chills labs body aches. At 3 am I had difficulty swallowing and a swollen neck. The next day this continued with a fever of 99-100, malaise, and chest discomfort. At the 48th hour, today?s date, fever still present, body aches are improved, but my head feels hot and now with a stiff neck. I feel very tired and mental status seems ?foggy?
45 2021-01-12 palpitations Pt received vaccine on left deltoid at 8:56am. Checked on pt at 9:05 pt stated she had itchiness on ... Read more
Pt received vaccine on left deltoid at 8:56am. Checked on pt at 9:05 pt stated she had itchiness on her back, heart palpitations and right handed numbness, and felt flushed. Provider made aware at 09:05. Vitals taken at 9:15 temp 98.8, heart rate 83, blood pressure 150/91, and oxygen saturation 96% on room air, at 9:26 BP 151/88, heart rate 73, and oxygen saturation 99% on room air, blood pressure rechecked at 9:32 and was 151/88. Vitals rechecked at 09:56 BP 164/89, heart rate 72, oxygen saturation 100% on room air, temperature 97.7, vitals checked again at 10:00 BP 158/95, heart rate 75, oxygen saturation 100% on room air, and temp 97.7. Heart palpitations resolved. Provider prescribed Diphenhydramine 25mg x2capsules to be taken at home. Provider referred patient to urgent care and follow up with PCP.
45 2021-01-12 palpitations Pt received vaccine on left deltoid at 8:56am. Checked on pt at 9:05 pt stated she had itchiness on ... Read more
Pt received vaccine on left deltoid at 8:56am. Checked on pt at 9:05 pt stated she had itchiness on her back, heart palpitations and right handed numbness, and felt flushed. Provider notified at9:05. Vitals taken at 9:15 temp 98.8, heart rate 83, blood pressure 150/91, and oxygen saturation 96% on room air, at 9:26 bp 151/88, heart rate 73, and oxygen saturation 99% on room air, blood pressure rechecked at 9:32 and was 151/88. Vitals rechecked at 9:56am temp 97.7, BP 164/89, HR 72, oxygen sat 100% on room air. Vitals at 10:00am BP 158/95, HR 75, oxygen sat 100% on room air, temp 97.7. Provider prescribed Diphenhydramine 25mg x2 capsules to be taken at home, and referred patient to urgent care and follow up with primary care provider.
45 2021-01-12 chest discomfort Pt reported chest tightness and throat tightness following vaccination. Time course following vaccin... Read more
Pt reported chest tightness and throat tightness following vaccination. Time course following vaccination unknown.
45 2021-01-12 chest discomfort, palpitations, pallor Vaccine administered at 08:16--08:25 patient c/o feeling unwell and dizzy 87, 143/84, 18, 100%; 08:2... Read more
Vaccine administered at 08:16--08:25 patient c/o feeling unwell and dizzy 87, 143/84, 18, 100%; 08:28: Pt c/o dizzy & chest tightness, appeared pale, monitoring; 08:34: Pt c/o increased chest tightness 130, 144/81, 22, 100% monitoring 08:36: Epinephrine .3mg given IM to R thigh, pt. reported flushing, pounding heart, 911 called; 08:40: Pt flushed.
45 2021-01-12 fainting, heart rate increased pt reported feeling rapid heart rate and faint. Skin cool and clammy, pt assisted to lie down, HR 13... Read more
pt reported feeling rapid heart rate and faint. Skin cool and clammy, pt assisted to lie down, HR 130's, BP 134/78. c/o feeling pressure in throat. Rapid response called and patient assisted to stretcher and transported to ED.
45 2021-01-13 chest discomfort, palpitations 15 minutes after vaccine administration, patient presented to EC complaining of chest pressure, palp... Read more
15 minutes after vaccine administration, patient presented to EC complaining of chest pressure, palpitations, lightheadedness and feeling faint. Patient's symptoms resolved by 4:15pm. Patient was prescribed Benadryl 50mg PO and PEPCID 40mg PO. Patient discharged from EC home at 6pm.
45 2021-01-13 chest pain shortness of breath, cough, sore throat, chest pain, myalgia, arm soreness, sweats, hot flashes, nau... Read more
shortness of breath, cough, sore throat, chest pain, myalgia, arm soreness, sweats, hot flashes, nausea, skin burning sensation, facial swelling
45 2021-01-14 chest discomfort After 10 minutes of vaccine, patient started to have tight chest, and numbness on opposite arm. Then... Read more
After 10 minutes of vaccine, patient started to have tight chest, and numbness on opposite arm. Then she couldn't remember her name and date of birth for 5 minutes. She then felt her throat was swelling. 911 was called and paramedics checked her blood pressure and vitals were within range. She was monitored at the hospital and was doing fine.
45 2021-01-14 fast heart rate, heart rate increased, blood pressure increased Approximately a minute after receiving it I felt a wave of heat start at my feet and go to my head. ... Read more
Approximately a minute after receiving it I felt a wave of heat start at my feet and go to my head. I then felt my heart rate increase. I took my heart rate from my apple watch and it was 145. Spoke to the nurse on site and she took my BP which was 185/140 (I am normally 120/80). Within a few minutes the heart rate started to drop but I was taken to the ED to be monitored. remained slightly tachicardic, but it was much better and BP dropped but was still elevated upon release -
45 2021-01-14 low platelet count COVID 19 vaccine - unsure which vaccination Flu like symptoms for 1 day with noted thrombocytopenia... Read more
COVID 19 vaccine - unsure which vaccination Flu like symptoms for 1 day with noted thrombocytopenia 127 x 10^3 Unclear if thrombocytopenia is from vaccination. No hx of this
45 2021-01-14 palpitations High Palpitations for the day.
45 2021-01-14 palpitations Patient felt heart racing, shaky, and flushed a few minutes after COVID shot number 1. VS 186/98 H... Read more
Patient felt heart racing, shaky, and flushed a few minutes after COVID shot number 1. VS 186/98 HR 97 RR 16 Temp 36.5 No SOB or throat tightness. Patient sat for 15 minutes after vital signs. Given water. Felt much better. BP 145/94 HR 87 RR 14. No more shaking of hands. Discharged from clinic and recommend to report for next shot and let them know to monitor for 30 minutes.
45 2021-01-14 chest discomfort wheezing hot flush sensation had to use a breathing treatment arm is really sore headache chest feel... Read more
wheezing hot flush sensation had to use a breathing treatment arm is really sore headache chest feels tight, almost like she is congested
45 2021-01-14 chest discomfort wheezing tight chest headache had to use a breathing treatment hot flush sensation
45 2021-01-15 palpitations Bounding heart rate in 150's dizziness confusion/ hallucinations chills body aches fatigue injection... Read more
Bounding heart rate in 150's dizziness confusion/ hallucinations chills body aches fatigue injection site pain
45 2021-01-16 heart rate increased Fever as high as 103.1 (after Motrin) Injection site pain Joint pain Headache Chills Skin sensitivi... Read more
Fever as high as 103.1 (after Motrin) Injection site pain Joint pain Headache Chills Skin sensitivity All over feeling unwell Increased heart rate (as high as 135)
45 2021-01-17 fast heart rate 5min after vaccine became tachycardic with blurred vision and felt like she was going to pass
45 2021-01-17 palpitations Facial tingling/numbness to face contralateral to injection site starting 30 minutes (time 1600) af... Read more
Facial tingling/numbness to face contralateral to injection site starting 30 minutes (time 1600) after injection and spreading to entire face. Symptoms resolved 4 hours later. Intermittent palpitations starting during this time which have not resolved to this day. Twelve hours (time 0330) after injection experienced common reported adverse effects (arthralgia, myalgia, headache, chills, severe neck pain, headache) in addition to unexpected supraclavicular lymph node swelling on injection side. Consistent fever of 102 degree fahrenheit starting 12 hours (time 0330) post injection and lasting for 20 hours, after which remained 99-100 for an additional 8 hours. Started to take Tylenol 15 hours after vaccine dose (0630). Also have continued to have dull headaches since vaccine dose.
45 2021-01-18 fast heart rate Cough, tachycardia, flushing. Initially improved without treatment, took antihistamine at home, but... Read more
Cough, tachycardia, flushing. Initially improved without treatment, took antihistamine at home, but cough and a feeling of pressure in face worsened. Cough persisted and she was unable to sleep that night. Took Benadryl, Pepcid and pushed fluids. No further airway prolbems, but did not work the next day. Was back at work and back to normal on Jan 15.
45 2021-01-18 fast heart rate Dizziness, eye swelling, throat tightness, sense of impending doom, mild tachycardia
45 2021-01-18 fainting Patient felt flushed, hot, faint occurring approximately 30 minutes after receiving vaccine. "Feels... Read more
Patient felt flushed, hot, faint occurring approximately 30 minutes after receiving vaccine. "Feels wierd." Feeling anxious. At 3:10pm, BP 165/74 HR=78 O2 sat=99%. At:3:30pm, BP=155/72. Symptoms improving. Patient released from clinic at 3:32pm.
45 2021-01-19 palpitations 3:35 patient feels shaky, dizzy, tingling. Feels numbness around her face especially lips. States sh... Read more
3:35 patient feels shaky, dizzy, tingling. Feels numbness around her face especially lips. States she feels like her heart is racing. HR 109; O2 96%, BP 120/84. Also states she feels like she is breathing fast. BBB CTA per Dr. Opened outside doors for cool air. Continue to observe 3:51 Patient reports feeling better; denies throat swelling. No dyspnea noted, Resp. regular. Still c/o slight dizziness and face feels sl. numb around cheek area. 3:58 - BP 138/p HR 113; O2 sat 99% on r/a 4:03 patient states she does not need an ambulance 4:12 116/82; HR 104; 99% Patient states she feels fine now and left ambulatory to her personal vehicle.
45 2021-01-19 hypertension Patient is a 45 year old female with no significant PMHX who presents today high blood pressure, nau... Read more
Patient is a 45 year old female with no significant PMHX who presents today high blood pressure, nausea and chills within 30 min of receiving the 1st dose of the COVID-19 vaccine 4 hours ago Denies rash, shortness of breath, vomiting, diarrhea, trouble swallowing or breathing, swelling of throat, tongue, lips or eyes. No fever. Patient states her BP was taken when she was having the symptoms and it was 170s systolic. Patient is presenting today with report of nausea, chills and elevated BP s/p COVID-19 vaccine. Patient has no evidence of anaphylaxis or severe allergic reaction. . Patient has normal vitals and in no respiratory distress. Will discharge home with close outpatient follow-up.
45 2021-01-19 palpitations Patient reports sudden onset of dizziness and heart palpitations. Initial vitals BP 224/117, HR 11... Read more
Patient reports sudden onset of dizziness and heart palpitations. Initial vitals BP 224/117, HR 112, RR 28 ,Pox 100% RA (at 1700) Repeat vitals at 1710 BP 217/110, HR 103, RR 32, Pox 97% RA. Symptoms became progressively worse. She was given water. She reports she takes Metoprolol and Nefedipine ( last dose 1/20/21) and HCTZ (last dose 1/19/21. She also began to report feeling weakness as well. Due to persistent symptoms she was transported to the ER at 1715 via wheelchair.
45 2021-01-19 fast heart rate pt started experiencing tachycardia, dizziness, and itchiness within 2 minutes of receiving vaccine.... Read more
pt started experiencing tachycardia, dizziness, and itchiness within 2 minutes of receiving vaccine. pt reported symptoms 2 hours after receiving vaccine and was given 25 mg of diphenhydramine. pt was monitored every 60 minutes for changes.
45 2021-01-20 chest pain Got it yesterday at noon, totally fine until 10pm. Worsening chills until midnight, then complete b... Read more
Got it yesterday at noon, totally fine until 10pm. Worsening chills until midnight, then complete body ache, muscles, joints, everything, terrible headache. Was on couch and walked upstairs. By the time I got there, I was nearly vomiting and on the verge of losing consciousness. I laid down on the cold tiles and tried to stay conscious. I couldn't even talk. Saliva was pouring out of my mouth uncontrollably. After awhile it let up enough to scoot into the bedroom and climb into bed. Then an entire night of worsening chills, fever, aches, eye pain, sore throat, pulsating ringing in my ears. Little if any sleep. I tried to get up and sit in a chair this morning at 3am and within minutes was so nauseated and light headed I had to lay back down flat. Tried to drink some hot tea and Gatorade at 5am. Thought I heard someone walking around the house and then realized it was heartbeat pounding in my ears. This morning my feet are super sensitive, I have urinary frequency and urgency, and the pulsatile tinnitus is back. Later today had episode of sharp chest pains front to back that resolved after about five minutes. Treatment has been rest today.
45 2021-01-20 chest pain Hives, shortness of breath, dizziness, chest pain, numbness of lip and face, felt like throat was cl... Read more
Hives, shortness of breath, dizziness, chest pain, numbness of lip and face, felt like throat was closing. Was rushed to the hospital.
45 2021-01-20 heart rate increased, chest pain Short of breath; Chest pain; Heart above 120s; Fatigue; This is a spontaneous report from a contacta... Read more
Short of breath; Chest pain; Heart above 120s; Fatigue; This is a spontaneous report from a contactable nurse (patient). A 45-year-old female patient received the first dose of bnt162b2 (BNT162B2), intramuscular on 18Dec2020 at 20:00 at a single dose at the left arm in the hospital for covid-19 immunization. Medical history included hypertension. Patient was not pregnant at time of report. The patient previously took excedrin [acetylsalicylic acid;caffeine;paracetamol;salicylamide] and experienced allergies. Concomitant medication included Tejocote root. The patient experienced heart above 120s, short of breath, fatigue, and chest pain, all on 21Dec2020 at 13:00. Patient went to a doctor or other healthcare professional office/clinic visit for the events. The patient received treatment which included Tylenol as needed for the events. Tested for Covid twice since the vaccination; Covid test post vaccination - Nasal Swab on 30Dec2020 and on unknown date, both with negative results. Cardiologist consult was pending. Outcome of the events was reported as not recovered. Information on the lot/batch number has been requested.; Sender's Comments: The 45-year-old female patient had medical history included hypertension, and was on concomitant medication. The reported events short of breath and chest pain were more likely due to underlying disease, and less likely causally related to first dose of bnt162b2 (BNT162B2). The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
45 2021-01-24 chest discomfort HA/CP/Flushed/SOB/Dizziness after 20minutes-- > was taken to ER
45 2021-01-24 chest discomfort, chest discomfort She had her second vaccine on 1/20/21 in her right arm. She noticed chills but no fever. She had bod... Read more
She had her second vaccine on 1/20/21 in her right arm. She noticed chills but no fever. She had body aches. Swelling in arm pits. Tightness in right chest and back. She did a lot of driving and arm went numb, but gone now she is home. Swelling in arm still there.
45 2021-01-25 blood pressure increased Started to feel bad when I left after 15 minutes wait time. Upon leaving I almost pulled into the ho... Read more
Started to feel bad when I left after 15 minutes wait time. Upon leaving I almost pulled into the hospital parking lot to wait, but decided to try and drive home. I began to feel light headed, dizzy, dry mouth, it felt hard to swallow. I knew I did not feel well so I drove myself to the fire station that was closest to me. They took my blood pressure upon arrival and it was 141/93. My normal blood pressure is around 116/63, so it was considerably high. I do not have a history of high blood pressure. The morning of the vaccination I had, had a very small cup of coffee and had eaten a piece of raisin bread. I had also taken two 250 mg generic acetaminophen tablets with 65mg caffeine prior to the vaccination. I also experienced chills and a low grade fever of 100 degrees.
45 2021-01-26 chest pain Chest pains so bad I had to go to emergency room. Pain started 2 days after and another day to subs... Read more
Chest pains so bad I had to go to emergency room. Pain started 2 days after and another day to subside in chest. Arm that was injected took an additional 2 days to feel better.
45 2021-01-26 heart rate increased Mouth and tongue tingling progressed to increased heart rate and flushing within 10 minutes of recei... Read more
Mouth and tongue tingling progressed to increased heart rate and flushing within 10 minutes of receiving vaccine. Transported to ER. Still has rash as of 1/27/2021 face, behind knees, and torso.
45 2021-01-26 fainting Systemic: Exhaustion-Medium, Systemic: Fainting-Medium
45 2021-01-26 heart rate increased, blood pressure increased, palpitations, chest discomfort, pallor intermittent dizziness; felt a "closing in" sensation/brain fog; pulse and blood pressure went up; p... Read more
intermittent dizziness; felt a "closing in" sensation/brain fog; pulse and blood pressure went up; pulse and blood pressure went up; severe headache; hot flushing; chest tightness; started getting pale; sweating; peripheral perfusion worsened; palpitations; This is a spontaneous report from a contactable nurse (patient). A 45-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), intramuscular in left arm on 31Dec2020 at 08:15 AM at a single dose for COVID-19 immunization in a workplace clinic. Medical history included mild asthma and known allergies to bee stings. There were no concomitant medications. Within a few minutes of the vaccine on 31Dec2020, the patient felt a "closing in" sensation and then her pulse and blood pressure went up. She developed a severe headache and hot flushing with chest tightness. The medical team gave her epinephrine in right thigh and she felt a bit better. Then she started getting pale, sweating, and peripheral perfusion worsened so she was given a second dose of epi. She started feeling better, but had a headache, palpitations and "brain fog" for about 5 days after and she still having intermittent dizziness (unspecified date). The patient received epinephrine IM and benadryl IV push for the events. The events resulted in emergency room/department or urgent care visit. The patient has no COVID prior to vaccination and was not tested for COVID post vaccination. The patient did not receive other vaccine in four weeks and other medications in two weeks. The patient recovered from the events with lasting effects. The patient had not yet recovered from the event dizziness, while the patient recovered with sequelae for the remaining events. Information on the lot/batch number has been requested.; Sender's Comments: The reported events were likely related to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), due to plausible temporal relationship. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
45 2021-01-26 chest discomfort joint pain/still having joint pain and muscle aches in her knees and lower legs; It is mainly irrita... Read more
joint pain/still having joint pain and muscle aches in her knees and lower legs; It is mainly irritating; still having joint pain and muscle aches in her knees and lower legs; body aches; a fever for about 3 days; feeling heaviness in her chest; She was chocking it up to anxiety; This is a spontaneous report from the contactable nurses (one is the patient). A 45-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date not reported), via an unspecified route of administration, on the right deltoid, on 04Jan2021 at a single dose as she wanted added protection (Covid-19 immunization). The patient medical history was not reported. The patient has no heart issues but has a family history of heart disease. The patient's concomitant medications were not reported. The patient was asking if it is okay to take second dose after experiencing side effects of fever, body ache, joint pain, probably anxiety, chest heaviness 8-10h after (not wheezing, 98% O2 saturation) which returned next day and subsided. On 04Jan2021, the patient got her first dose of the Pfizer COVID Vaccine, she was one of the lucky people who had joint pain, body aches, and a fever for about 3 days. She noticed about 8-10 hours after she got the vaccine that she started feeling heaviness in her chest, chest felt tight and heavy; not shortness of breath, harder to take a deep breath. She had no wheezing. In Jan2021, her oxygen level was 98%. She was chocking it up to anxiety in Jan2021. It went away. She had it the same day and the next day intermittently. It was short and passing. She is still having joint pain and muscle aches in her knees and lower legs. It is intermittent and mainly at night. She is supposed to get the second dose next Friday and asking should she go ahead and get the second dose. The joint pain had went away intermittently on Tuesday, then hit her harder on Wednesday. Thursday she felt okay but the Friday again was having the pain. It is still occurring. It is mainly at night. In the day she feels okay. It is when she lays down to relax that it kicks in. It is mainly irritating but she would say it is medically significant as it has lasted for a while, almost 2 weeks now and she is still having issues. She takes 1000mg of acetaminophen (TYLENOL) to knock it out. The heaviness in her chest lasted about 1.5 hours the first day, and then went into Tuesday intermittently. The patient recovered from anxiety in Jan2021, body aches and fever on 07Jan2021, heaviness in her chest recovered on 05Jan2021, while other events were not recovered. The reporter assessed the events of Joint pain and muscle aches in her knees and lower legs, and irritating as medically significant. The reporter causality of the events for joint pain and muscle aches in her knees and lower legs, body aches, fever and heaviness in her chest were related to the suspect drug, causality for other events was not reported. Information about lot number/batch number was requested.; Sender's Comments: Based on the information currently provided, the vaccination with BNT162B2 might play a contributory role in triggering the onset of events of Joint pain and muscle aches in her knees and lower legs and irritating. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
45 2021-01-27 fast heart rate 5 days after the first shot(12/24/2020), I started feeling extremely fatigued. I had axilla lymphad... Read more
5 days after the first shot(12/24/2020), I started feeling extremely fatigued. I had axilla lymphadenopathy, dizziness, nausea, joint pain, muscle pain and periods of tachycardia when standing. This lasted for 7 days. The lymphadenopathy was diagnosed in a routine mammogram/ultrasound screening 9 days after the vaccine. I finally started feeling better the week I was scheduled to receive my second shot. I got my second shot on 1/14/2021. Within 12 hours, I had a 101 fever and muscle aches. I also had axilla lymphadenopathy. Within 3 days, I was feeling better, however about 8 days post vaccine, I started to experience bouts of tachycardia and dizziness again. As time progresses, these symptoms are slowly improving.
45 2021-01-27 fast heart rate Panic; Anxiety; Vertigo; Flushing feeling; Tachycardia; This is a spontaneous report from a contacta... Read more
Panic; Anxiety; Vertigo; Flushing feeling; Tachycardia; This is a spontaneous report from a contactable nurse (patient). A 45-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number El01Y0, expiration date not reported), intramuscular on the left arm, on 08Jan2021 at 10:30, single dose for Covid-19 immunization. The patient has no medical history and no concomitant medications. The patient previously took the first dose of bnt162b2 (Lot number: EJ1685), intramuscular on the right arm, on 18Dec2020 at 10:00 AM for Covid-19 immunization. The patient is not pregnant at the time of vaccination. Patient has no allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 08Jan2021, at 10:35, the patient experienced flushing feeling with tachycardia 5 minutes post vaccine. On 15Jan2021, she is day 7 post vaccine and experiencing panic/anxiety, tachycardia, and vertigo type feelings. Since the vaccination, the patient has not been tested for COVID-19. The patient received treatment (prescription/monitoring) for the events. The outcome of the events was not recovered. The reporter assessed the events as non-serious. Information on the lot/batch number has been requested.
45 2021-01-27 palpitations, heart rate increased Patient with a PMH significant for allergic rhinitis and cyclic neutropenia, as well a pre-syncope w... Read more
Patient with a PMH significant for allergic rhinitis and cyclic neutropenia, as well a pre-syncope with previous blood donations received COVID-19 vaccine at 0645 and approximately 1 hour later developed a generalized feeling of warmth, followed by lightheadedness/dizziness. She denies frank LOC. She also reports palpitations and a rapid heart rate. She denied any rash, pruritis, dyspnea or chest pain, or N/V/D. Patient works in hospital and was transported to ED and upon arrival vitals were stable with HR of 79, BP 151/84, SaO2 of 100% on RA. Additional information for Item 18: Patient treated with IVF and released. Patient discharged to home and by 1:00pm that day was no longer symptomatic. She does endorse pre-syncope with previous blood draws.
45 2021-01-28 blood pressure increased Reported had severe headache the same night. Worse the next day. Tongue and lip swelling. BP spike... Read more
Reported had severe headache the same night. Worse the next day. Tongue and lip swelling. BP spiked, severe headache, severe abd pain, seen at Urgent Care and sent to ER. Given meds and sent home. Next day seem at clinic and again sent to ER. . Given IV fluids, IV meds and after four hrs sent home. Experienced extreme weakness. Could barely get out of chair or walk. ED visit 1/15/2021 for acute nonintractable headache, epigastric pain, adverse effect of vaccine. Presents to the ER with epigastric abdominal pain, nausea, and headache after receiving second dose of Pfizer COVID-19 vaccination yesterday at 6 AM. Patient states symptoms started last night. Treated with IV fluids, Reglan, Benadryl, Toradol, and Floricet. Abdominal pain totally resolved and headache pain improved. Discharged to home with prescription for Reglan 10mg PRN. She does have a history of chronic migraines and already has Maxalt at home and was given a prescription for Floricet today which she is already filled.
45 2021-01-28 hypertension, oxygen saturation decreased feeling of throat closing/HTN/drop in O2 sat, itchy throat dizziness
45 2021-01-29 blood pressure increased, heart rate increased About 5-10minutes after vaccine I felt flushed/warm. Reported to nurse who took my vitals. Elevated... Read more
About 5-10minutes after vaccine I felt flushed/warm. Reported to nurse who took my vitals. Elevated blood pressure and heart rate. Also felt slightly dizzy. Symptoms lasted about 45 minutes. At no time did I experience itching/swelling or rash. Also did not experience wheezing or difficulty breathing. Only treatment needed was vital sign monitoring. Vitals improved and no intervention was needed. I have had no further complications.
45 2021-01-29 blood pressure decreased Pretreatment with prednisone 50 mg q6 x 3 doses starting 13 hours prior plus Benadryl 50mg po 1 hour... Read more
Pretreatment with prednisone 50 mg q6 x 3 doses starting 13 hours prior plus Benadryl 50mg po 1 hour prior. 20-25 minutes after injection began itching, rash on upper body, redness to body, lightheaded when stood up. Sought treatment from nurse & paramedic on site. Vital signs about 30 minutes after injection 187/107, hr 135, sats 98%. Given Benadryl 25 mg IM . Over next 30 minutes symptoms improved & bp came down to 145/80 and hr around 100. That evening whole body was red & rash on upper body- took Benadryl 50 mg. A week out remain with mild rash on chest, arms, neck & itching that comes & goes. Have been treating with Claritin during the day & Benadryl at night for 6 nights. Days 2& 3 after injection feet felt very cold, but face felt very hot when wearing a mask.
45 2021-01-29 fast heart rate, hypertension Tachycardia, high blood pressure, flushing Given Benadryl and observed in the ER
45 2021-01-31 blood pressure decreased, palpitations 1 minute after injection felt a very uncomfortable sensation of heat come over entire body, I felt h... Read more
1 minute after injection felt a very uncomfortable sensation of heat come over entire body, I felt heart palpitations and a sensation that my heart was racing. I then became lightheaded and dizzy and my hands and lips/cheeks became numb and tingling and I got very shaky. I summoned paramedics who came and took vitals and my heart rate was in 130s with blood pressure of 190/100, I have no prior history of high blood pressure or high resting heart rate. Blood pressure came down to normal level within 30 minutes, other symptoms improved and I was cleared to leave vaccination site. Intermittent numbness in face and hands and general shakiness persisted through the next 12 hours and heart rate stayed 100-120 for 12 hours before returning to my normal rate of 60.
45 2021-01-31 hypertension, blood pressure decreased, blood pressure increased, heart rate increased, palpitations 1 minute after injection felt a very uncomfortable sensation of heat come over entire body, I felt h... Read more
1 minute after injection felt a very uncomfortable sensation of heat come over entire body, I felt heart palpitations and a sensation that my heart was racing. I then became lightheaded and dizzy and my hands and lips/cheeks became numb and tingling and I got very shaky. I summoned paramedics who came and took vitals and my heart rate was in 130s with blood pressure of 200/110, I have no prior history of high blood pressure or high resting heart rate. Blood pressure came down to 160/92 within 30 minutes, other symptoms improved and I was cleared to leave vaccination site. Intermittent numbness in face and hands and general shakiness persisted through the next 12 hours and heart rate stayed 100-120 and blood pressure was elevated for 12 hours before returning to my usual results.
45 2021-01-31 blood pressure increased DAY 1 (Thurs. 1/14/21 - received 2nd dose of the vaccine at 8:49 am central time): 15 MINS POST SHOT... Read more
DAY 1 (Thurs. 1/14/21 - received 2nd dose of the vaccine at 8:49 am central time): 15 MINS POST SHOT: acute tingling around mouth and tongue; BP spiked and face became very flushed. Waited with nurse until 1 hour post shot. BP stayed above normal all day, as did fatigue. 12 HOURS POST SHOT: sever headaches warranting migraine medicine but I only took Tylenol and Ibuprofen since Maxalt (10 mg) can raise BP. Alternated Tylenol and Ibuprofen every 3 hours but would only get about 2 hours of relief each time. This continued through the night. DAY 2 (Fri. 1/15/21): 23 HOURS POST SHOT: Headache remained. but was lessened after taking Mucinex D. Extremely fatigued, which remained throughout the day. 24 HOURS POST SHOT (9:00 am): Saw NP at clinic, BP was normal. Was prescribed Fioricet, ESGIC 50-325-40 and advised to take it if headache returned. If ineffective after 2 hours, advised to take Maxalt 10 mg. 10:10 am: took Fioricet with no impact to headache, took Maxalt at 12:10. 28 HOURS POST SHOT: Severe, painful heartburn in my chest and upper back - Mylanta provided no relief. Headache returned and started having severe abdominal pain and shortness of breath. 29 HOURS POST SHOT (~2PM) Went to urgent care; vitals were all normal. Received fluids and "GI cocktail" containing lidocaine. Heartburn pain subsided but headaches and abdominal pain. Was advised to go to Emergency Department and did. ED ran multiple labs and ECG to rule out gallbladder, pancreas, etc. Headaches and abdominal pain at this point were excruciating and debilitating. Shortness of breath was significant. ED staff said they have seen the different reactions I was having to the vaccine, just not all together in one patient at the same time. Pain subsided after fluids with Benadryl, Toradol and Reglan. Was discharged approximately 4 hours after arrival. MD prescribed Reglan for continued headaches through the weekend. DAY 3 (Sat. 1/16/21): 48 HOURS POST SHOT: Severe headache when I awoke. Reglan did not provide relief. After two hours, took Maxalt 10 mg . Headaches and significant fatigue continued with such severity I took Maxalt as frequently as allowed per dosing instructions. I stayed in a dark room until Monday (1/18/21, Day 5), ensuring I was staying well hydrated and nourished. The fatigue was so significant that movement was very labored. It should be noted that I am a very active person and I had zero energy and missed two days of work (Fri and Mon). DAY 4: headaches were less frequent DAY5 (Mon. 1/18/21): At 3:30 PM (~126 hours post shot) - it was like someone flipped a light switch and the fatigue and headaches were gone and I felt like I was back to normal. DAYS 6-7, (Tues. and Wed 1/19-20/21) - worked a normal day at work. DAY 8 (Thu. 1/21/21): extremely fatigued again, like over the weekend, but it only lasted today. Of note, the lips and tongue tingling would come and go following the initial weekend of severe reactions. While noticeable, it was not as significant as within the first 15 mins of receiving the dose. On Monday 1/25/21 at approximately 3:00 PM, the tingling was very noticeable and my BP spiked again. Since that time until now, I have had no reactions.
45 2021-01-31 nosebleed Reported feeling hot flashes, nosebleed, chills, lifht headedness, nausea, fatigue, body aches, swol... Read more
Reported feeling hot flashes, nosebleed, chills, lifht headedness, nausea, fatigue, body aches, swollen lymph under jaw on neck.
45 2021-01-31 heart rate increased, heart rate decreased heart rate increased to 120-125 bpm and lasted about an hour. Came down to normal over an additional... Read more
heart rate increased to 120-125 bpm and lasted about an hour. Came down to normal over an additional hour
45 2021-01-31 fainting nausea, emesis, syncope, as well as extended tiredness, headache, joint pain, fever
45 2021-02-02 loss of consciousness Patient refers that He started to feel dizziness and loss of consciousness, was evaluated for parame... Read more
Patient refers that He started to feel dizziness and loss of consciousness, was evaluated for paramedics who took her blood pressure having 80/50, Patient recovered, felt better and didn't wanted to go to the hospital.
45 2021-02-03 chest discomfort Approximately 18 hours post injection I began running a fever with severe body aches and headache. 2... Read more
Approximately 18 hours post injection I began running a fever with severe body aches and headache. 24 hours after onset of initial symptoms, I developed diarrhea. 72 hours after injection, I noted a large painful lymph node in the axilla of the injection side. Fever and malaise continue in addition to cough and chest tightness
45 2021-02-03 chest discomfort, hypertension, heart rate increased Approximately 20 min after vaccine I felt my left lower arm between wrist and elbow get very tight. ... Read more
Approximately 20 min after vaccine I felt my left lower arm between wrist and elbow get very tight. I began to feel lightheaded and hot in chest. Vitals were take , BP was very high and HR was very high. My checks got tingly as well. I began to get the chills. This lasted approximately 2 hours.
45 2021-02-03 hypertension Stress on body; Little over weight- usually about 150 sometimes 162 around this time she was 162; St... Read more
Stress on body; Little over weight- usually about 150 sometimes 162 around this time she was 162; Stage 3 kidney failure; High/Increased blood pressure; Outbreak of genital herpes; Hip pain bilateral; Extreme fatigue; on and off headaches/Intermittent headache; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231; expiration date not provided), via an unspecified route of administration (anatomical location: arm left) on 04Jan2021 at SINGLE DOSE for COVID-19 immunisation. Patient's medical history ongoing included sickle cell trait (diagnosed as a child, sickly as a child, found out in 2016. It was reported that patient has the sickle cell that mimics the disease), ongoing high blood pressure, and ongoing genital herpes, and pre-diabetes, all diagnosed prior to vaccination, and 'blood pressure'. Concomitant medication included chlorthalidone from 2018 and ongoing for 'blood pressure'. It was reported that patient got her first dose of Covid vaccine on 04Jan2021. Patient stated that she has been experiencing some effects, started maybe 2 days after, she began experiencing fatigue (06Jan2021). Patient also stated that she has genital herpes diagnosed before the vaccine, and stated that she usually doesn't have an outbreak unless there is extreme stress on body. On 08Jan2021, patient clarified she experienced a genital herpes outbreak and thought that it may associated. Patient stated that she treated it with valaciclovir (VALTREX) and some cream and it went away. States that she had another outbreak after, treated it again, and it went away and now she is struggling with another outbreak of genital herpes. Patient also reported that she has on and off headaches (also reported as intermittent headaches) on 04Jan2021, states this could be due to her high/increased blood pressure which she first experienced on 14Jan2021 (as reported). Patient mentioned that her blood pressure has been higher than it ever has been after the vaccine. Patient also stated that she noticed that after the vaccine it was out of control, that she got a blood pressure cuff and it was 149/103, she contacted her nephrologist, stated she is treating it with her usual diuretic and the doctor just prescribed her amlodipine (NORVASC). Patient further stated that she is still struggling to get the diastolic blood pressure in the 90s, stated this is abnormal for her. Also is experiencing severe hip pain bilateral on 08Jan2021 after the vaccine. Patient further reported that she was a little over weight - usually about 150 sometimes 162 around this time she was 162. Patient clarified that her current weight is 159.2 and stated that she was diagnosed with sickle cell trait and stated that she has the kind that mimics the disease and will have a lot of side effects of sickle cell disease. Patient further added that she also has stage 3 kidney failure on 18Jan2021 due to either her high blood pressure or sickle cell trait and is also pre-diabetic. Patient also thought that the outbreak was associated with stress on body. Patient wanted to know if she refuses the second vaccine, if the first vaccine will do anything. Outcome of the events 'Stage 3 kidney failure', 'High/Increased blood pressure', 'Outbreak of genital herpes', and 'on and off headaches/Intermittent headache' was not recovered, outcome of the event 'extreme fatigue' was recovered on 06Jan2021, outcome of the event 'hip pain bilateral' was recovering, outcome of the remaining events was unknown.; Sender's Comments: The reported stage 3 kidney failure was due to either the pre-existing high blood pressure or sickle cell trait or prediabetic condition, and was unrelated to the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE).
45 2021-02-04 platelet count decreased, fainting, haemoglobin decreased, cardiac arrest, fibrin d dimer increased, low blood oxigenation In discussion with Dr., medical director at Detox, she arrived night of 2/3/21 was quite intoxicate... Read more
In discussion with Dr., medical director at Detox, she arrived night of 2/3/21 was quite intoxicated so was not going through any withdrawal. She was getting vitals and CIW checked regularly. First dose of chlordiazepoxide 25mg was 2/4 at 1:25pm for CIWA 9. She had repeat vitals at 5:50pm, CIWA 1, vitals: P 67, 118/79, 94% on RA, T 98.3. she had complained of some "pressure in her head" and feeling anxious, but otherwise denied other complaints. she was talking with others in the group, then other patients report she suddenly started having seizure like activity around 6:45pm, med techs came to help and found her stiff, gurgling. they tried to get vitals on her, called 911, noticed that at 6:54pm she had lost a pulse and they started CPR. paramedics arrived at 7:08pm and she was brought to ED. Pt BIBA in cardiac arrest. Pt was at Detox Center when she was reported to have seizure-like activity followed by collapse. She was found to be pulseless and CPR initiated by staff members. EMS arrived and performed approx 15 min of CPR and gave pt epi x 3 and bicarb. No shocks administered but they did not report a rhythm. In the emergency room the patient arrived and was found to be pulseless with PEA arrest, CPR was initiated, patient was intubated. ROSC ultimately achieved, patient remained very acidotic despite ventilator adjustment, head CT revealed cerebral edema. Pt also found to be profoundly anemic with a hemoglobin of 5 and platelets of 37, she was thought to be GI bleeding so medications for this were initiated. Patient then became more hypoxemic with bradycardia, consultation with neurosurgery and critical care medicine at tertiary care center deemed ongoing CPR futile. Patient arrested at 2:30AM on 2/5, pronounced dead at 2:48AM.
45 2021-02-04 heart rate increased, blood pressure increased My arm at the injection site got very swollen and red and I had red streaks across my back. Symptoms... Read more
My arm at the injection site got very swollen and red and I had red streaks across my back. Symptoms began 14 hours after injection. I had the normal fever, nausea, chills, body aches, also had severe ear pain in my left ear same as when I had Covid. Dizziness began 14 hours after but increasingly got worse. My blood pressure went up to 200/118 with my HR 131 with the dizziness. I have NEVER had high blood pressure!! I still have some dizziness. Not completely resolved. BP is better but still high at times. I have been monitoring it closely. I did go to the ER where my BP continued to be high.
45 2021-02-04 fainting Patient states that her physician advised against second dose. She states she had a severe headache ... Read more
Patient states that her physician advised against second dose. She states she had a severe headache for days following vaccine, she collapsed at work and was hospitalized for a few days. She also reports ongoing dizziness. All information was left in a private message sent to the health departments social media page. Further requests for information have been unsuccessful thus far.
45 2021-02-04 palpitations, chest pain headache; tiredness; get palpitations; chest pain; arm weakness when standing too long; Anxiety; Thi... Read more
headache; tiredness; get palpitations; chest pain; arm weakness when standing too long; Anxiety; This is a spontaneous report from a contactable other HCP (patient). A 45-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number reported as 5730, pending clarification), via an unspecified route of administration on 18Dec2020 at single dose in left arm for COVID-19 immunisation. Patient age at vaccination was 45 years. The patient was vaccinated at hospital. No other vaccine was given within 4 weeks prior to the COVID vaccine. Medical history included asthma and known allergies to epinephrine, latex, sulfa. Concomitant medications included amoxicillin (AMOXICILLIN), ibuprofen (MOTRIN). On 19Dec2020 at 01:00 PM the patient had headache and tiredness ever since get palpitations, chest pain, arm weakness when standing too long or when first get up. Heart doctor thinks it's due to vaccine or anxiety but never had this before shot. The events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Treatment for the events included anti anxiety medication, metoprolol. The events had not resolved. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination the patient was tested for COVID-19 (nasal swab) on 18Jan2021 which resulted negative. Information about lot/batch number has been requested.
45 2021-02-07 heart rate decreased Client reports had tingling in back of throat and tongue, took a Benadryl and symptoms subsided. Cl... Read more
Client reports had tingling in back of throat and tongue, took a Benadryl and symptoms subsided. Client reports taking Benadryl all evening long. Client reports 3 days later having migraines, nausea, head ache and not feeling well. Day 3 pulse dropped in the 40's which is abnormal. Denies trouble breathing. Client reports had similar symptoms of migraines but not additional symptoms.
45 2021-02-07 cerebrovascular accident Employee reports having a stroke 2 weeks after vaccination that required hospitalization.
45 2021-02-08 fainting, loss of consciousness Syncope; passed out; This is a spontaneous report from a contactable pharmacist reported that a 45-y... Read more
Syncope; passed out; This is a spontaneous report from a contactable pharmacist reported that a 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318), intramuscular on the left arm on 25Jan2021 15:00 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received flu vaccine on an unspecified date for immunization and experienced fever. On 25Jan2021, the patient was experienced syncope and passed out. She woke up within the next couple of minutes and was monitored. The patient eaten food. The outcome of the events was unknown.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported events, syncope and passed out, and the administration of COVID-19 vaccine, BNT162B2, based on the reasonable temporal association, and lacking alternative explanations. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
45 2021-02-08 fainting, blood pressure increased faint; feeling off; feel dizzy/light headed; dry mouth; hard to swallow; They took my BP upon arriva... Read more
faint; feeling off; feel dizzy/light headed; dry mouth; hard to swallow; They took my BP upon arrival and it was 141/93; chills; low grade fever 100 degrees; This is a spontaneous report from a contactable 45-year-old female other health professional reported for herself that she received 1st dose of bnt162b2 (lot number EL8982) on 15Jan2021 08:00 AM at left arm for Covid-19 immunization. Medical history included hereditary angioedema from unknown date (last episode 2015). The patient had not received other vaccines within 4 weeks prior to COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant drug included caffeine, paracetamol (ACETAMINOPHEN AND CAFFEINE). The patient reported that after waiting the 15 minutes, she walked to her car, and started feeling off. She thought about sitting in the hospital parking lot, but started to drive home. She started to feel dizzy, light headed, faint, dry mouth, hard to swallow so she drove herself to the fire station. They took her blood pressure (BP) upon arrival and it was 141/93 and blood sugar was 90 on 15Jan2021. She was 120 pounds and her normal BP was 116/63. The event onset time was reported as 15Jan2021 08:30 AM. Later on 15Jan2021, the patient had chills and low grade fever 100 degrees. Treatment was received for the events. The events were resolved on unknown date. Events were reported non-serious. Since the vaccination, the patient has not been tested for COVID-19.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the event syncope cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
45 2021-02-09 heart rate increased metallic taste in her throat; strange sensation; very rapid heart rate; This is a spontaneous report... Read more
metallic taste in her throat; strange sensation; very rapid heart rate; This is a spontaneous report from a contactable health care professional (patient). A 45-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL9262), via an unspecified route of administration on 23Jan2021 at 08:30 on the left arm at a single dose for COVID-19 immunization. Medical history included allergy to penicillin. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included omeprazole (manufacturer unknown). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, has the patient has not been tested for COVID-19. The patient reported that minutes after the injection, she had a metallic taste in her throat, strange sensation, and then very rapid heart rate. It subsided in about two minutes. The patient did not receive any treatment for the events. The patient recovered from the events. The events were reported as non-serious.
45 2021-02-09 nosebleed ~9 days of vaginal spotting (in between menses), and several mild nosebleeds.
45 2021-02-14 loss of consciousness passing out; vomiting; tingling; severe pain shoulders; tingling/severe pain shoulders and all of ba... Read more
passing out; vomiting; tingling; severe pain shoulders; tingling/severe pain shoulders and all of back/torso, legs ached; tingling/severe pain shoulders and all of back/torso, legs ached; pain all over/torso; slight head ache; chills/cold; chills/cold; turned to temp 99.9; very warm/uncomfortable; fatigue; This is a spontaneous report from a non-contactable nurse (patient). This 45-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot# EL3249), via an unspecified route of administration on 29Jan2021 09:30 at single dose in the left arm for COVID-19 immunization. The patient's medical history was none. No known allergies. The patient's concomitant medications included naproxen (occasional) in two weeks. The patient previously took first dose of bnt162b2 (Lot number: EK9231), on 07Jan2021 at left arm for COVID-19 immunization. Facility type vaccine was hospital. No other vaccine received in four weeks. Patient got vaccine at 9:30am. Woke up morning (30Jan2021) after the vaccine about 9:30am with tingling/severe pain shoulders and all of back/torso, legs ached. During shower at that time, very close to vomiting/passing out. Took NSAID and slept. Then paracetamol (TYLENOL) mid day. That evening had fatigue and pain all over, slight head ache, chills/cold and then turned to temp 99.9, very warm/uncomfortable. Paracetamol again that night before bed. Woke on Sunday better just fatigue and achy. No treatment received. No COVID prior vaccination. No COVID tested post vaccination. Outcome of the events was recovered in 2021. No follow-up attempts are possible. No further information is expected.
45 2021-02-14 heart rate increased stomach was a little upset; very tired; her heart rate is a little higher, like 95; she feels like n... Read more
stomach was a little upset; very tired; her heart rate is a little higher, like 95; she feels like nausea; tongue was tingling a little bit; whole body was tingling; headache; her tongue feels like it is tingling and dry; has pain in her right hand since she got the vaccine dose in her right upper arm; feeling a little bit febrile, her temperature was 99 degrees Fahrenheit; This is a spontaneous report from contactable consumers. A 45-year-old female patient receive the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EC1283, via an unspecified route of administration in the right arm, on 24Jan2021 17:00 at SINGLE DOSE for covid-19 immunization. Medical history included blood pressure, and on birth control. She recently started taking the blood pressure medication (lisinopril) three months ago her blood pressure was due to a lot of stress, and she was not feeling good she had her doctor to see her blood pressure her doctor then put her on this (lisinopril). She stated that she took Lisinopril 5mg at night last night as well as took her birth control pill. Concomitant medication included lisinopril for blood pressure; ethinylestradiol, ferrous fumarate, norethisterone acetate (JUNEL FE), pantoprazole and an unspecified flu shot injection to arm in October (year not specified; she takes the flu shot every year). The patient received BNT162B2 on an unspecified date for covid-19 immunization; on the first dose of COVID-19 vaccine, she felt nothing, just a little tired and she had pain in her left hand. However, it was different for the second dose. Fifteen (15) minutes after getting her second dose of vaccine, the patient was fine. Then after 30 minutes, she came home and felt like her whole body was tingling, and her tongue was tingling a little bit. She says she did drink some water. She did no treatment other than drink some water and take and hold breath in and out, holding her breath a little bit. She says her body was tingling for just a second, that is gone, her tongue feels like it is tingling and dry, kind of like when you taste something spicy a little bit, that kind of experience. She says that it lasted like 1- 2 hours yesterday and it is not going, she still feels it a little bit on her tongue, the rest of her body is not tingling. She also experienced headache and has pain in her right hand since she got the vaccine dose in her right upper arm. Today(25Jan2021), she was feeling very tired, her heart rate was a little higher, like 95, and she was feeling something like nausea, her stomach was a little upset today, and she was feeling a little bit febrile, her temperature was 99 degrees Fahrenheit when she took it. Outcome of events was reported as 'unknown'. No follow-up attempts are possible. No further information is expected. Information on the batch/lot number has been obtained.
45 2021-02-16 fainting Fainting; shortness of breath; hand spasms; nausea; vomiting; This is a spontaneous report from a co... Read more
Fainting; shortness of breath; hand spasms; nausea; vomiting; This is a spontaneous report from a contactable other health care professional (HCP) reporting for herself. A 45-year-old female patient not pregnant received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Left arm (at age of 45-year-old) on 13Jan2021 at 01:00 PM as a single dose for COVID-19 immunisation, lot number: EL3249. Medical history included penicillin allergy. Patient did not receive any other medications within two weeks prior to the vaccination. Patient did not receive other vaccine in four weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. On 16Jan2021 at 06:00 PM patient experienced nausea, vomiting, shortness of breath, fainting and hand spasms. Events resulted in Emergency room/department or urgent care. Patient was treated at emergency room (ER) with diphenhydramine hydrochloride (BENADRYL), Steroid and Anti nausea. Patient was not tested for Covid post vaccination. Patient recovered on unknown date in 2021 from the reported events.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
45 2021-02-16 chest pain Throat and mouth "feels funny" following injection of Covid vaccine approx 1717. Slight chest burnin... Read more
Throat and mouth "feels funny" following injection of Covid vaccine approx 1717. Slight chest burning. Patient ambulated. Drinking water without diffuculty. Patient states tongue "feels funny" after getting covid vaccine. Patient states within minutes after the injection her tongue began to feel funny. She denies oral/lip swelling, numbness/tingling, difficulty swallowing, drooling, headache, nausea/vomiting, chest pain, shortness of breath. She also states her chest was burning just after receiving the vaccination however that has since resolved. No palpitations or syncope. No recent illness. No history of adverse reaction to vaccines. No known food/medication allergies. Patient is sitting comfortably on the exam table drinking water without difficulty. Patient states at this time her mouth feels better but "does not feel normal." Patient states she has a history of mitochondrial myopathy and has some esophageal motilty issues at baseline. 1808: patient was given diphenhyramine 25 mg PO x 1. She reports mild improvement in symptoms. No headache, dizziness, nausea, oral edema, difficulty swallowing, chest pain, shortness of breath. 1830: patient states symptoms have resolved. She is sitting comfortably in the chair. No signs of distress. She states she thinks she got too anxious. No headache, dizziness, nausea, oral edema, difficulty swallowing, chest pain, shortness of breath. Patient states she feels comfortable leaving at this time. Discussed ED precautions. Patient verbalized understanding. Advised patient to follow up with her PCP to discuss second dose of covid vaccine. 1/15/21: Pt received 2nd dose of vaccine. About 10 minutes after, pt developed a rash at injeciton side. Rash spread up chest and onto back. Pt was taken to convenient care for further evaluation. At convenient care, pt stated she had no difficulty breathing but that something just didn't feel right. Rash spread to right arm and started to itch. Pt endorsed experiencing throat/tongue swelling but did not think it was closing off or actualy swelling. Pt received epinephrine 0.3 mg IM x 1 and diphenhydramine 25 mg IM x 1. After treatment and about 1.25 hours of monitoring, pt felt well enough to go home. Pt was prescribed epinephrine 0.3 mg IM 2-pak kit. 1/15/21: Pt received 2nd dose of COVID vaccine and develped rash. Pt received epinephrine 0.3 mg IM x 1 and diphenhydramine 25 mg IM x 1. Discharged to home after treatment and monitoring with prescription for epinephrine 0.3 mg IM 2-pak kit.
45 2021-02-16 palpitations, chest discomfort injection site pain; chest discomfort (fluttering, thud feeling, tightness); chest discomfort (flutt... Read more
injection site pain; chest discomfort (fluttering, thud feeling, tightness); chest discomfort (fluttering, thud feeling, tightness); chest discomfort (fluttering, thud feeling, tightness); shortness of breath; fatigue; This is a spontaneous report from a contactable consumer reporting for herself. This 45-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL3247 and expiry date unknown) on 16Jan2021 at 11:00 via an unspecified route of administration into right arm at a single dose for COVID-19 immunization. The patient had known allergies to penicillin, erythromycin, garlic. Other medical history included asthma. She was not pregnant. The patient had not had COVID prior to the vaccination. Nasal Swab (for COVID) tested on 19Jan2021 was negative. Concomitant medications in two weeks included venlafaxine and ceirizine hydrochloride (ZYRTEC). No other vaccine received in four weeks. The patient experienced chest discomfort (fluttering, thud feeling, tightness), shortness of breath, fatigue since 17Jan2021 11:00, and injection site pain since 01Feb2021. The events resulted in doctor or other healthcare professional office/clinic visit. The patient received prednisone and formoterol fumarate;mometasone furoate (DULERA) as treatment for the adverse events. The patient had not recovered from the events.
45 2021-02-17 lightheadedness Nearly passed out; Postural Orthostatic Tachycardia Syndrome; icy like pulsation through my blood oc... Read more
Nearly passed out; Postural Orthostatic Tachycardia Syndrome; icy like pulsation through my blood occurred; fell to the ground; This is a spontaneous report from a contactable consumer reported for herself. A 45-year-old female patient (not pregnant) received the first dose of bnt162b2 (Pfizer-Biontech Covid-19 Vaccine), Lot number: EL9261, via an unspecified route of administration on 06Feb2021 12:30 at single dose in Left arm for covid-19 immunisation. Facility type Vaccine was Hospital. Medical history included anaemia, no known allergies. Patient had COVID-19 starting on 06Jan2021 and persisting through 16Jan. Her COVID symptoms were crushing chest pain, no fever, blood oxygen level never dropped below 98%. The patient's concomitant medications were not reported. There were no other vaccine in four weeks. Patient was experiencing Postural Orthostatic Tachycardia Syndrome. Nearly passed out going to the toilet when she first awoke. An icy like pulsation through her blood occurred first thing this AM, day after the vaccine. She fell to the ground and called for her husband to help her. He gave her 500mg acetaminophen and aspirin. She slept. Same thing happened with pulse 140+, he measured, as she showered. They stopped the shower, she laid down and recovered. When she got up immediately the pulse rises to 120+. Adverse events started from 07Feb2021 08:30 AM. Therapeutic measures were taken in response to the events. The outcome of the events was not recovered. Covid was not tested post vaccination.
45 2021-02-17 lightheadedness Vasovagal response; This is a spontaneous report from a contactable consumer. A 45-year-old female ... Read more
Vasovagal response; This is a spontaneous report from a contactable consumer. A 45-year-old female patient reported that she received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL3247) into the left arm on 01Feb2021 08:15 AM at single dose for COVID-19 immunization. Age at vaccination 45 years. Concomitant drugs included multi-vitamin, D3, AERids eye vitamins. The patient had not history of allergies to medications, food, or other products. On 01Feb2021 at 08:30 AM the patient experienced a vasovagal response.Occupational Health/Wellness nurse checked blood pressure and had her lay down with legs up. After 10 minutes she went away and felt back to normal. No treatment was received. The outcome was recovered.
45 2021-02-22 chest discomfort The employee received her second COVID-19 Vaccine at 0744. At 820 she c/o dry mouth and a "funny f... Read more
The employee received her second COVID-19 Vaccine at 0744. At 820 she c/o dry mouth and a "funny feeling in her chest, but not pain." The employee was brought into the observation room and given 25mg of PO Benadryl. Her VS were 65-18-128/79-98%. Her lung sounds were clear. At 0825 Dr was notified and he came to the clinic. At 0831 the employee states that the chest feeling was improving, her lips and mouth were feeling better. 0910: 57-18-129/75-99% The employee states that she has had an allergic reaction to Versed and Haldol
45 2021-02-23 blood pressure increased, blood glucose increased, heart rate increased 3:30 am 2/19- Extreme body ache, headache; 8:00 am couldn't stand up, fever, chills, elevated blood ... Read more
3:30 am 2/19- Extreme body ache, headache; 8:00 am couldn't stand up, fever, chills, elevated blood pressure & heart rate, dizziness, complete fatigue and meltdowns and very high blood glucose . This lasted till 2/20 until around 5:30 pm
45 2021-02-23 chest pain, blood pressure increased Waves of extreme nausea; chills; dizziness; Shakiness; Vomiting; elevated temperature; Elevated bloo... Read more
Waves of extreme nausea; chills; dizziness; Shakiness; Vomiting; elevated temperature; Elevated blood pressure; heavy burning sensation in my chest; extreme body aches; so dizzy I can barely stand; This is a spontaneous report from a contactable consumer reported for herself. A 45-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at left arm on 01Feb2021 15:00 at single dose for COVID-19 immunization. The COVID-19 vaccine was administered at Workplace clinic. Medical history included Migraine, anxiety. Patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included sertraline hydrochloride (ZOLOFT), thyroid, naltrexone hydrochloride (NALTREXON). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had Allergies to Erythromycin, morphine. The patient received the first dose of BNT162B2 via an unspecified route of administration at right arm on 08Jan2021 02:30 PM for COVID-19 immunization. The patient experienced Waves of extreme nausea, chills and dizziness, Shakiness, Vomiting and elevated temperature. Elevated blood pressure on 02Feb2021 15:15, After a week and a half in Feb2021, the patient had heavy burning sensation in her chest, extreme body aches, so dizzy she can barely stand. Events were assessed as serious with seriousness criteria-Disabling/Incapacitating. Adverse event result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient underwent lab tests and procedures which included Blood tests, electrocardiogram (EKG), chest X-ray on an unknown date in Feb2021 with unknown results, Nasal Swab Covid test on 02Nov2020: Negative. The outcome of the events was not recovered. Information on the lot/batch number has been requested.
45 2021-02-23 chest pain headache, flushing, nausea , vomiting and chest pain after 2nd dose. vitals were stable with stron... Read more
headache, flushing, nausea , vomiting and chest pain after 2nd dose. vitals were stable with strong pulses pt took zofran that she brought home. encouraged rest, and fluids. provided cold compress and reassurance pt laid down in a stretcher and rested for about an hour before getting discharged home.
45 2021-02-24 fainting, loss of consciousness pt to observation s/p vaccination. pt began to feel dizzy and thirsty. on eval, pt become syncopal a... Read more
pt to observation s/p vaccination. pt began to feel dizzy and thirsty. on eval, pt become syncopal and ems notified and on scene with medical staff on site. Pt had LOCx2. Vitals taken. BS checked and EKG completed. IV started. pt then taken to local hospital for further eval.
45 2021-02-25 fainting The patient presents with symptoms that started immediately after pt received her first covid vaccin... Read more
The patient presents with symptoms that started immediately after pt received her first covid vaccine around 1000 today at center. she developed lightheadedness, sob, nausea, h/a, and when er triage nurse was triaging her she syncopized for 3-4 seconds. no fall. pt was seated. and pt also reports that earlier she felt like the room was spinning. Tx in the ED w zofran and discharged.
45 2021-02-26 chest discomfort, lightheadedness Blood pressure 65/33. Severe Diarreaha, moderate abdominal cramps, severe dizziness, close to fainti... Read more
Blood pressure 65/33. Severe Diarreaha, moderate abdominal cramps, severe dizziness, close to fainting. Minor chest pressure
45 2021-02-28 chest discomfort Chest pressure 10 min after injection Throat tightness couple mins later
45 2021-02-28 chest discomfort Immediately after receiving Pfizer Covid vaccine, patient developed hoarseness and tried to clear he... Read more
Immediately after receiving Pfizer Covid vaccine, patient developed hoarseness and tried to clear her throat. She had mild flushing as well. The hoarseness was on and off for a few minutes. Pulse ox was 97-98% on room air and was given PO Pepcid 40mg and PO Benadryl 50mg while in vaccine clinic. She was transported to the ED (chief complaint recorded as "hoarseness, chest tightness, SOB, throat swelling") where she was given IV Pepcid 20mg, IV Benadryl 50mg and IV SoluMedrol 125mg. She remained on room air and vital signs remained within normal limits. The patient was monitored for 2h before discharged home. Patient was given an outpatient prescription for Medrol DosePak and Pepcid.
45 2021-02-28 chest discomfort Same day of vaccine later on that night I started getting a headache. The next morning I felt body a... Read more
Same day of vaccine later on that night I started getting a headache. The next morning I felt body aches, tired, as the day went on I started feeling tightness of chest, had to take deep breath this was around 10 or 11am then my supervisor said to go to the ER, They did an x-ray & covid test it came out negative & in the x-ray came back normal.
45 2021-02-28 fainting, hypotension Vasovagal Near Syncope Lightheadedness, Hypotension, Nausea Patient is a 45-year-old female wi... Read more
Vasovagal Near Syncope Lightheadedness, Hypotension, Nausea Patient is a 45-year-old female with history of hypertension, anxiety. Patient received vaccination at 14: 05, approximately 5 minutes later at 14:10, Vasovagal response
45 2021-02-28 hypertension Very high Blood Pressure that was fluctuating but not lowering for several hours. Sent to ER after ... Read more
Very high Blood Pressure that was fluctuating but not lowering for several hours. Sent to ER after 1.5 hours at the clinic. No treatment given at ER, Bloodwork, urine, and ECG all normal with no indication of any type of organ damage resulting from uncontrolled High Blood Pressure. Sent home after 3 hours with blood pressure of 179/95 and pulse rate of 104 with recommendation to monitor blood pressure and follow up with primary care. By Feb 13 blood pressure became normal and has stayed in the normal range.
45 2021-02-28 fainting after having the fever of 102, fainting and throwing up I had horrible vertigo and nausea. had to g... Read more
after having the fever of 102, fainting and throwing up I had horrible vertigo and nausea. had to go on anti vert and anti nausea meds, now 1 month later, I am still dizzy in the morning, my muscles ache terrible , especially my lower leg muscles , joint pain, and I am so exhausted
45 2021-03-01 oxygen saturation decreased Low oxygen SaO2 of 79-86% with exertion and during sleep leading to extreme weakness, inability to s... Read more
Low oxygen SaO2 of 79-86% with exertion and during sleep leading to extreme weakness, inability to sleep and shortness of breath. In addition, swollen and painful lymph glands under both arms but worse in injection arm.
45 2021-03-03 heart rate increased fever, rash and swollen around the shot area, dizziness, fast heart beat a few minutes after receivi... Read more
fever, rash and swollen around the shot area, dizziness, fast heart beat a few minutes after receiving the second shot.
45 2021-03-04 fainting Fainted; Fainted/aggravated it; chills; fever; Headache; body aches; All night woke up with sweats a... Read more
Fainted; Fainted/aggravated it; chills; fever; Headache; body aches; All night woke up with sweats and burning; All night woke up with sweats and burning; All night woke up with sweats and burning; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received the second dose of bnt162b2 (Lot/batch number and Expiration date were not provided), via an unspecified route of administration in left arm on 20Feb2021 08:30 at single dose for covid-19 immunization. Medical history included Vasovagal synchope, allergy to Sulfa drugs. Concomitant medication included venlafaxine hydrochloride (EFFEXOR), metoprolol. The patient previously allergy to cipro and levaquin. The patient previously received the first dose of bnt162b2 (Lot number unknown), at the age of 45-year-old, via an unspecified route of administration in left arm on 28Jan2021 15:30 at single dose for covid-19 immunization. About 11 hours after 2nd dose (20Feb2021 19: 30), the patient got extreme chills and fever, headache and body aches. All night woke up with sweats and burning. Fainted around 21Feb2021 06:00 (patient had vasovagal synchope so maybe aggravated it). No treatment received. The patient was no pregnant. The outcome of the events was recovering. Information on the lot/batch number has been requested.
45 2021-03-04 chest pain chest pain; Shortness of breath; This is a spontaneous report from a contactable other health profes... Read more
chest pain; Shortness of breath; This is a spontaneous report from a contactable other health professional (patient herself). A 45-year-old female patient (non-pregnant) received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 10Jan2021 (at the age of 45-years-old) in left arm at single dose for covid-19 immunisation. The patient medical history was not reported. Patient had no chronic illnesses and no allergies. The patient had no COVID prior vaccination and was not tested COVID post vaccination. Other medications in two weeks was none. The patient previously took the first dose of bnt162b2 (Pfizer) on 21Dec2021 12:00 PM via intramuscular in left arm for COVID-19 immunization. The patient experienced chest pain and shortness of breath on 15Feb2021 01:00 (as reported). Clinical course: She took her second vaccine on 10Jan2021. Two weeks after the vaccine she was admitted to the hospital with chest pain and shortness of breath x2, one on 19Feb2021 (as reported) and the second time was 24Feb2021. On an unspecified date, all the blood works and CT (computerised tomogram) scan came back negative. She was a healthy individual until she took this vaccine. She also did Echocardiogram which came back negative. Events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, life threatening illness (immediate risk of death from the event). No treatment was received for events. Outcome of events were unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently provided, chest pain and shortness of breath occurred 2 weeks following the second vaccine are more likely associated with coincidental medical conditions unlikely related to the vaccine use. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
45 2021-03-07 fainting groggy; Headache; metallic taste; sweating; shivering; feeling like I was going to either have verti... Read more
groggy; Headache; metallic taste; sweating; shivering; feeling like I was going to either have vertigo spell or throw up; balance unsteady; feeling numbness in left arm; Exhausted/tired; feeling faint; This is a spontaneous report from a contactable consumer reported for herself. A 45-year-old female patient (No Pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL9267), left arm on 18Feb2021 14:15 at single dose for COVID-19 immunisation. Medical history included overweight, pre-diabetic. The patient did not diagnose with COVID-19. No allergies to medications, food, or other products.The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination included multivitamin. Shot on Thursday. No problem on Friday. Headache Saturday morning 20Feb2021 06:30 AM. After dinner on 20Feb2021, she had a metallic taste in her mouth started sweating and feeling faint then started shivering and feeling like she was going to either have a vertigo spell or throw up. Ballance unsteady. Drank water got into bed and then she started feeling numbness in her left arm. Exhausted and tired. Sunday tired and groggy. Monday still tired and groggy. Events were non serious. Since the vaccination, the patient has not been tested for COVID-19. No treatments were received. Outcome of the events was not recovered.
45 2021-03-17 fast heart rate, lightheadedness body rash; tachycardic; near syncope; This is a spontaneous report from a contactable other health c... Read more
body rash; tachycardic; near syncope; This is a spontaneous report from a contactable other health care professional (patient). A 45-year old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date unknown) via an unspecified route of administration on the left arm on 05Jan2021 at a single dose for COVID-19 immunisation at the hospital. Medical history included asthma, clotting disorder and allergies. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. However, it was reported that the patient had other medications received within 2 weeks of vaccination. The patient was not diagnosed with COVID019 prior to vaccination. The patient experienced body rash, tachycardia, near syncope on 20Jan2021. As a result, the patient went to the doctor office; clinic visit and emergency room/ department or urgent care. The patient received Cortisone injections, oral steroids and antihistamine in response to the events. The events were considered as non-serious by the reporter. The outcome of event recovering. Since the vaccination, the patient has not been tested for COVID-19. The patient received the second dose of bnt162b2 (lot number: el3246, expiration date unknown) on 26Jan2021 at 9:30 AM via an unspecified route of administration on the left arm at a single dose for covid-19 immunization. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender's Comments: Based on the information received, the reported serious events of Generalized rash, Tachycardia and Pre-syncope were plausibly consequent to single dose for COVID-19 immunisation. The impact of this report on the benefit/risk of profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
45 2021-03-24 blood glucose increased Coughing; Dizziness; Vaccine site became red, hot, hard; Vaccine site became red, hot, hard; Vaccine... Read more
Coughing; Dizziness; Vaccine site became red, hot, hard; Vaccine site became red, hot, hard; Vaccine site became red, hot, hard; Fever; Body aches; She felt like she was going to die; feels awful; Constipation; Couldn't keep her eyes open; Chills; Sore arm; Tired; couldn't keep her eyes open; Nauseousness; Lightheaded; it felt like someone was playing with my head and controlling her memories; sugar levels going up; This is a spontaneous report from a contactable consumer (patient). This 45-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EN6205 and expiration date 30Jun2021 received on 03Mar2021 as a single dose (at the age of 45 years), unspecified route in left arm for COVID-19 immunisation. History included thyroid removed in 2014 and diabetes in 2019 (diagnosed about a year and a half ago), Cirrhosis liver, fatty liver. Concomitant medications include metformin for diabetes, glyburide for diabetes, levothyroxine sodium (TIROSINT) for thyroid disorder, cetirizine hydrochloride (ZYRTEC), omeprazole, ascorbic acid (VITAMIN C), zinc, ergocalciferol (VITAMIN D), bifidobacterium lactis (PROBIOTIC), fluticasone propionate (FLONASE), albuterol (SALBUTAMOL), and budesonide, formoterol fumarate (SYMBICORT). Following the vaccination on 03Mar2021, she came home at night with sore arm and started getting chills. She felt very nauseous. She could not open her eyes anymore. She went to sleep and woke up in the middle of the night. She felt like someone was controlling her memories. It felt like someone is taking away memories (Mar2021) and she was trying to hold on. Like something was messed up in her head. The next day she woke up with a sore arm and felt fine. She had a little nauseousness but it was controlled. On Friday (04Mar2021), the vaccine site became red, hot, hard, and had a white ring around it. The more red it became the more fever, nauseousness, and constipation she had. She couldn't keep her eyes open. She started coughing. She had to use her inhalers even more. Her inhalers are Albuterol and Symbicort and she doesn't have a lot number to provide for her inhalers. All day she felt that way. She felt like she was going to die, has body aches. It was awful. She also had dizziness at nighttime she took the ice pack and froze her arm because she couldn't take it anymore. Saturday, 05Mar2021 she woke and still had dizziness and couldn't go to the bathroom. She feels nauseous. She can't keep her eyes open. Sunday (06Mar2021) it was better (unspecified events), but she is not herself. Ever since then she feels like she is always tired. Today it has been a week after and she is so tired. She called the number and one of the representatives said she wouldn't do the second dose. The doctor said it is side effect. She also reported that she is lightheaded. She said her sugar numbers have been sky high. She told the nurse that it didn't hurt like the flu shot. She did not have NDC, lot, and expiry to provide for flu shot. Lab information in Mar2021 included Sugar levels were up and weight: 203 to 205 pounds. Outcome of events was unknown.
45 2021-03-24 hypertension, chest discomfort, heart rate increased Instant Lupus flare; Instant extremely high blood pressure and pulse rate; Instant extremely high bl... Read more
Instant Lupus flare; Instant extremely high blood pressure and pulse rate; Instant extremely high blood pressure and pulse rate; Instant red face; tightness in chest/Instant hot fire feeling in stomach and chest.; Instant hot fire feeling in stomach and chest; Shortness of breath; Sore throat; diarrhea; upper back pain; Tiredness; rash on arm; chills; insomnia; This is a spontaneous report from a contactable consumer. A 45-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 18Mar2021 08:00 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included lupus, high blood pressure, asthma, anemia. No pregnant. No covid prior vaccination. No known allergies. No other vaccine in four weeks. Other medications in two weeks. The patient's concomitant medications were not reported. The patient experienced instant lupus flare, instant extremely high blood pressure and pulse rate, instant hot fire feeling in stomach and chest, instant red face, shortness of breath, tightness in chest, sore throat, diarrhea, upper back pain, tiredness, rash on arm, chills, insomnia on 18Mar2021 08:15 with outcome of recovered. The patient underwent lab tests and procedures which included heart rate: instant extremely high, blood pressure measurement: instant extremely high, sars-cov-2 test(Nasal Swab): negative on 07Jul2020, on 11Nov2020, on 15Dec2020, on 01Feb2021. Treatment received as Emergency care and needed extra bp and Lupus meds. The patient experienced Emergency room/department or urgent care, life threatening illness (immediate risk of death from the event). Information on the Lot/Batch number has been requested.
45 2021-03-24 blood pressure increased blood pressure was at 203/118; light headed; This is a spontaneous report from a contactable consume... Read more
blood pressure was at 203/118; light headed; This is a spontaneous report from a contactable consumer (patient). A 45-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6204, expiration date not provided), via an unspecified route of administration, at the age of 45 years old, administered in Left arm on 12Mar2021 14:30 at single dose for covid-19 immunisation. Medical history reported as none and there were no known allergies. There were no concomitant medications. There were no other vaccines received in four weeks. The patient did not have covid-19 prior vaccination and did not test for covid-19 post vaccination. The patient experienced blood pressure was at 203/118 and light headed on 12Mar2021 14:45. The reported events resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event). Specifically, it was reported that within 15 minutes of having the vaccine at 14:45 12Mar2021, the patient started feeling light headed, head pressure. Paramedics came to check on her and found out her blood pressure was at 203/118. The patient ended up in the emergency room on Friday 12Mar2021, again on 13Mar2021 for another incident of high blood pressure and on 16Mar2021 and her blood pressure was still high. The patient has never suffered of high blood pressure until after the vaccine. The patient's doctor has prescribed blood pressure meds and will monitor for two weeks to see if it can bring blood pressure down. Treatment Hydrocochlorothiazide 12.5mg and Lozartan were taken as a result of events blood pressure increased and light headedness. The outcome of the events was not recovered.
45 2021-03-26 pulmonary embolism, chest pain I had my second vaccine on Monday, 3/22, and woke up at 1am on Thursday 3/25 with extreme chest pain... Read more
I had my second vaccine on Monday, 3/22, and woke up at 1am on Thursday 3/25 with extreme chest pain, shortness of breath, sweating and chills. I went to the ER, and they discovered two blood clots in my lungs. I've never had pulmonary embolisms before, so this is a very strange coincidence. I am in cancer treatment, so my risk of PEs is higher, but the timing is too close for me not to think that the second vaccine traumatized my immune system, causing the PEs.
45 2021-03-30 deep vein blood clot Deep vein thrombosis in right calf; received bnt162b2, dose 2 on 15Jan2021/first dose on 29Dec2020; ... Read more
Deep vein thrombosis in right calf; received bnt162b2, dose 2 on 15Jan2021/first dose on 29Dec2020; received bnt162b2, dose 2 on 15Jan2021/first dose on 29Dec2020; This is a spontaneous report from a contactable physician (patient). A 45-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in the left arm on 15Jan2021 (Batch/Lot number was not reported) at a single dose for covid-19 immunisation. The patient received the first dose on 29Dec2020 in the left arm for covid-19 immunisation. The patient did not receive any other vaccines in four weeks. Medical history included allergies: Sulfa. Patient was not pregnant at the time of report. The patient has not had COVID prior vaccination and was not tested post vaccination. Concomitant medication included ethinylestradiol, levonorgestrel (SEASONIQUE) taken for birth control. The patient experienced deep vein thrombosis in right calf on 13Feb2021 with outcome of recovering. The event deep vein thrombosis in right calf resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient received aspirin regimen as treatment for the event deep vein thrombosis in right calf.; Sender's Comments: Based on the information currently available, the event deep vein thrombosis most likely represents an intercurrent medical condition and was unrelated to Bnt162b2 vaccine. A possible contributory role of concomitant drug ethinylestradiol, levonorgestrel to the event can not be totally excluded. Case will be re-assessed upon the additional information provided. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
45 2021-04-01 blood clot Patient complains of shortness of breath about 5-10 min after vaccine. BP was taken because patient ... Read more
Patient complains of shortness of breath about 5-10 min after vaccine. BP was taken because patient stated she has high BP and a history of stroke. BP was158/114. 911 was called and ambulance arrived in 10 -15min. EMT assessed patient and asked her to smile. Patient's left face was not responding normally, Patient asked to lift both arms. Patient could not fully lift both arms. Patient transported to hospital.
45 2021-04-01 fast heart rate Tachycardia; Rash; This is a spontaneous report from a contactable healthcare professional. This is ... Read more
Tachycardia; Rash; This is a spontaneous report from a contactable healthcare professional. This is the second of two reports for the same patient with reoccurring events separated in time. A 45-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), second dose (Batch/Lot Number: UNKNOWN) via an unspecified route of administration on 26Jan2021 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. The vaccination was received at the hospital. Medical history included asthma, clotting disorder and allergies. The patient did not receive any other vaccines within 4 weeks prior to the BNT162B2 vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included unspecified medications. It was reported that the patient had received other medications within 2 weeks of vaccination. The patient previously received the first dose of BNT162B2 on 05Jan2021 for COVID-19 immunisation and experienced tachycardia, rash and presyncope. The patient developed tachycardia and rash which started approximately 2 weeks after the first vaccine and worsened after the second vaccine on 26Jan2021. The tachycardia and rash required a visit to the Emergency Room and Physician Office. Treatment included steroid injections, oral steroids and Diphenhydramine (BENADRYL). The patient was not admitted to the hospital. The outcome of event tachycardia was recovered on an unknown date. The outcome of event rash was recovering. The healthcare professional reported casual effect of the events tachycardia and rash to the vaccine. The lot number for the vaccine was not provided and will be requested during follow up.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of tachycardia and rash due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including EKG, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021092876 same patient/reporter, different vaccine dose and event.
45 2021-04-12 haemoglobin decreased No adverse events for 1st dose, 2nd dose was temporally correlated with autoimmune hemolytic anemia
45 2021-04-13 pulmonary embolism, excessive bleeding, blood clot Blood clot in lower right leg (calf), resulting in pulmonary embolisms and use of blood thinners. D... Read more
Blood clot in lower right leg (calf), resulting in pulmonary embolisms and use of blood thinners. Due to fibroids, this caused excessive bleeding leading to anemic condition and the need for several blood and iron transfusions. Solution was to perform hysterectomy to eliminate fibroids and bleeding to be able to continue use of blood thinners for blood clot condition.
45 2021-04-13 cerebrovascular accident Severe headaches and ear pain on right side of ear. She thought she was getting migraines (but hadn... Read more
Severe headaches and ear pain on right side of ear. She thought she was getting migraines (but hadn't suffered from migraines in over 20 years). Went to doctor on 3/3 due to severe pain. No thoughts of what it could be. Continued headaches with no relief. Received migraine shots in hip on night of 3/11. Severe stroke on 3/13. Should not be at risk for a stroke and does not have any typical factors for being at risk. Has been in hospital and in-patient rehab since. Has a fully occluded clot in her right ICA.
45 2021-04-20 heart attack immune system was low; shingles; heart attack; This is a spontaneous report from a contactable consu... Read more
immune system was low; shingles; heart attack; This is a spontaneous report from a contactable consumer (patient) via Medical Information, also received via Pfizer-sponsored program. A 45-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 23Mar2021 as SINGLE DOSE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Within 5 hours after receiving the dose, she developed shingles on 23Mar2021. She stated the pain was so bad she thought she was having a heart attack on an unspecified date in 2021. Her medical doctor (MD) told her that she should get the second dose of the vaccine and that the shingles was dormant in her system and because her "immune system was low" she developed the shingles outbreak. The patient further stated that she developed shingles 4 hours later after receiving the first dose. She stated that the eruptions have stopped but it was still painful. She was asking if she should get the second covax or wait. The patient had not yet recovered from shingles while outcome of the rest of the events was unknown. Follow-up attempts are needed. Further information on the lot/batch number has been requested.
45 2021-04-24 loss of consciousness is passing out at 7PM; had two antibody tests and she's been negative; Patient verifies she is not d... Read more
is passing out at 7PM; had two antibody tests and she's been negative; Patient verifies she is not dizzy, she just feels like yuck; Patient states she has pain; she felt like she couldn't breathe; she felt like, not herself, like un-well. Patient states she is feeling unwell since; zapping, basically like a electric shock; nausea and vomiting; nausea and vomiting; extreme fatigue/that night she was exhausted, she couldn't pick up her head; head just doesn't feel right/she couldn't pick up her head; fever; closing of her throat; heat coursing through her body, felt heat in her vessels/she was a bloody, hot mess; chills; This is a spontaneous report from a contactable other health professional. A 45-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 26Mar2021 at 10:00 (Batch/Lot Number: ER8733) as single dose for COVID-19 immunization. Patient states she had chronic strep throat, she was sick four times a year for the first 12 years of her life. Patient stated she has no allergies, she was a healthy woman. Concomitant medication included simvastatin taken for an unspecified indication from 2020 and ongoing. On 26Mar2021, the patient experienced nausea/vomiting happened almost immediately, soon after the injection. The patient stated she wasn't feeling well, she had to go home from work, but the symptoms started that day almost immediately and persisted for a few days later. She has this zapping. The patient stated it was actually a term, it's basically like an electric shock that she was feeling throughout her body, like from head to toe on 08Apr2021. The patient stated and her head just doesn't feel right, just like dizziness. The patient stated she has pain and was uncomfortable. Patient stated she was concerned about what to do moving forward. Patient stated the day she got the shot, within three minutes, she felt like she couldn't breathe. Patient stated it was not emotional, she's very self aware, she was a psychologist. Patient stated it was a closing of her throat, but that has turned on and off as well. Patient stated then she had heat coursing through her body, felt heat in her vessels, down the center of her throat down in to her throat into the center chest and down into legs. Patient stated that night she was exhausted, she couldn't pick up her head. Patient stated she threw up and had chills, she felt like, not herself, like un-well. Patient states she was feeling unwell since. Patient states she did travel that Monday after, which she doesn't know if it made it worse, but was gone only for an hour, then got sick again that night with fever and throwing up. Patient states then yesterday, she started getting these zaps in her body, it felt like someone had put a taser to her all over her body. Patient stated she was just not herself, she wasn't at her normal. Patient stated she passed out at 7PM at night. Patient verified she was not dizzy, she just felt like yuck. Patient stated she also experienced chills and fever, that happened later that day on 26Mar2021. Patient stated she came back to work and she just felt like she needed to go home. She was instantly not well. Patient stated she has had two antibody tests and she's been negative. Patient stated she checked after that, she made sure she had no antibodies. Patient clarified she checked her antibodies twice before getting the vaccine. Patient stated her resting heart rate was at 55, she was in athletic shape, she was healthy. Patient stated when she had the both, she was on the toilet and throwing up at the same time, she was a bloody, hot mess. Patient states she ripped her clothes off, she was hot. The outcome of the event nausea, vomiting, fatigue, "head just doesn't feel right" was recovered with sequel on 03Apr2021l; fever was recovered with sequel on 07Apr2021; chill was recovered on 03Apr2021; electric shock was not recovered and unknown for the other events. The patient did not received any recent vaccines for SARS-COV2 other than Pfizer- BioNtech COVID-19 Vaccine prior to the event being report and has not received any other vaccines around the time of Pfizer- BioNTech Vaccine Vaccination.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
46 2020-12-31 blood pressure increased, palpitations Pt endorses onset of 2.5 hours ago. Endorses associated rash, numbness, palpitations, and elevated b... Read more
Pt endorses onset of 2.5 hours ago. Endorses associated rash, numbness, palpitations, and elevated blood pressure. She reports getting the COVID-19 vaccine this morning, and after having been given the vaccine developed elevated blood pressure, palpitations described as "her heart feels hot", shortness of breath, a diffuse rash, and some generalized numbness. Patient called EMS after her symptoms did not resolve on their own, who gave her 50mg of IV Benadryl and transported her to the ED. Received solumedrol and famotidine IV in ED. Erythema noted on neck  
46 2021-01-01 lightheadedness Acute onset of reactogenicity reaction as patient was leaving grocery store. Almost crashed car driv... Read more
Acute onset of reactogenicity reaction as patient was leaving grocery store. Almost crashed car driving due to violent rigors. Single episode explosive diarrhea upon arrival home. Patient incapacitated on couch for 3.5 hours due to shaking chills, dizziness, headache, profound weakness, near syncope when attempting to get up. Patient unable to reach phone to summon help for over an hour. (phone was only 2 feet from patient).
46 2021-01-01 lightheadedness Experienced dizziness, lightheadedness 1 hour post vaccine. Started to feel throat swelling on 12/1... Read more
Experienced dizziness, lightheadedness 1 hour post vaccine. Started to feel throat swelling on 12/18/20. Went to ED on 12/20/20. Not reported as serious adverse effect, but medical record labeled with moderate reaction. Diagnosis: vasovagal episode. Discharged stable.
46 2021-01-04 blood pressure increased, chest discomfort I experienced Fatigue, chest tightness, and increased blood pressure the first 2 days. Day 5 I start... Read more
I experienced Fatigue, chest tightness, and increased blood pressure the first 2 days. Day 5 I started having pain in my upper back, left side. The next day had increased discomfort and developed a rash. Today, it is extremely painful and spread from the upper back to across my left breast. My PCP agrees that it is Shingles. I am beginning a course of Valtex today, to lesson the severity of symptoms.
46 2021-01-04 heart rate increased Patient had SVT; flushing; hives; heart rate increased to 160's (had been 180's earlier in the day);... Read more
Patient had SVT; flushing; hives; heart rate increased to 160's (had been 180's earlier in the day); This is a spontaneous report from a contactable pharmacist. A 46-year-old female patient received the first dose of BNT162B2 (lot number: EK5730), via intramuscular, on 28Dec2020 at single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was hospital. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, it's unknown if the patient was tested for COVID-19. No other vaccines were received within 4 weeks prior to the COVID vaccine. The patient's medical history and concomitant medications were not reported. The patient had SVT, flushing, hives 20 min after receiving vaccine on 28Dec2020. Patient was taken to ED and evaluated. SVT resolved. Patient sent home on heart monitor. Later that night while in bed, heart rate increased to 160's (had been 180's earlier in the day) and patient was admitted to hospital. Patient is a NP. Treatment received for the adverse event included cold water to face, vagal massage. The outcome of the event"Patient had SVT" was recovered on 28Dec2020 and of other events was recovering.; Sender's Comments: A causal association between BNT162B2 and the reported events supraventricular tachycardia, flushing, hives, heart rate increased cannot be excluded based on the compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
46 2021-01-04 fast heart rate Thyroiditis with hyperthyroidism: 5 days after vaccine developed sweats, 10 days after the vaccine (... Read more
Thyroiditis with hyperthyroidism: 5 days after vaccine developed sweats, 10 days after the vaccine (1/1/21)developed fevers and right sided neck pain, tachycardia, myalgia
46 2021-01-04 chest discomfort flushing; chest pressure; lightheadedness; This is a spontaneous report from a contactable nurse (pa... Read more
flushing; chest pressure; lightheadedness; This is a spontaneous report from a contactable nurse (patient). A 46-year-old female (not pregnant) patient received BNT162B2 (lot number EH 9899) first dose intramuscularly on right arm on 30Dec2020 09:30 AM at single dose for COVID-19 immunization. Medical history included HTN/GERD, allergies to pineapple and sulfa. Concomitant medications in two weeks included diltiazem (CARDIZEM), valsartan (DIOVAN), omeprazole (PROTONIX), meloxicam (MOBIC), docusate and bupropion hydrochloride (WELLBUTRIN). No other vaccine in four weeks. Patient experienced flushing, chest pressure and lightheadedness on 30Dec2020 09:30 AM, resulted in: Emergency room/department or urgent care and received treatment as ER evaluation. No COVID prior vaccination. No COVID tested post vaccination. The outcome of the events was recovered in Dec2020. The seriousness was reported as no.
46 2021-01-05 blood pressure increased, heart rate increased Dizziness, nausea, chills, tired/heavy feeling In legs, odd sensation in right leg with numbness of ... Read more
Dizziness, nausea, chills, tired/heavy feeling In legs, odd sensation in right leg with numbness of right toe. Blood pressure and heart rate mildly elevated beginning around 10:40 pm 1/5/21. Spoke with a triage nurse twice late pm 1/5/21 and early am 1/6/21. Advised self monitoring. Unable to sleep more than about 1 hr at a time-woke up sweaty. No temp. Woke up without dizziness/nausea but had dizziness when eating cereal and looked down. Saw general practice physician 1/6/21 after 10 am 1/6/21. Given anti-dizziness med. prescription. Dizziness/nausea, Tired/heaviness in legs gone when saw physician. Still mild altered sensation in right leg and big toe numbness that comes and goes. Elevated blood pressure at physician. Bloodwork ordered and scheduled for Saturday.
46 2021-01-05 palpitations Ongoing heart palpitations, breathlessness, tremulous hands, jittery feeling, sweating, PMS symptoms... Read more
Ongoing heart palpitations, breathlessness, tremulous hands, jittery feeling, sweating, PMS symptoms earlier and worse than usual. EKG showed PVCs.
46 2021-01-05 heart rate increased rapid heart rate; shortness of breath; This is a spontaneous report from a contactable physician rep... Read more
rapid heart rate; shortness of breath; This is a spontaneous report from a contactable physician reported for herself. A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EH9899, expiry date unknown) intramuscular at left arm on 27Dec2020 09:45 at single dose for Covid-19 immunization in a hospital facility. Medical history included hypothyroidism. The patient was not diagnosed with Covid-19 prior to vaccination. Concomitant medications included levothyroxine from unspecified date for unspecified indication. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. On 27Dec2020 less than 5 minutes after receiving the vaccine, the patient developed rapid heart rate and shortness of breath. The patient has not been tested for Covid-19 post vaccination. The patient did not receive treatment for the events. The outcome of the events rapid heart rate and shortness of breath was recovered in Dec2020. The reporter considered the events non-serious; did not results in death, was not life threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, and no congenital anomaly/birth defect.
46 2021-01-06 fast heart rate 01/06/2021 r eyelid swollen, face and upper lip; provider gave epi -- reduced some swelling. L wris... Read more
01/06/2021 r eyelid swollen, face and upper lip; provider gave epi -- reduced some swelling. L wrist swelling today 1/07/2020 sinus tachycardia 140-150.
46 2021-01-06 blood pressure increased, chest pain, fainting, palpitations Fainting; Red Palms; blotching; sweating profusely; heart palpitations; Chest pain; Elevated BP; Thi... Read more
Fainting; Red Palms; blotching; sweating profusely; heart palpitations; Chest pain; Elevated BP; This is a spontaneous report from a contactable consumer (patient). A 46-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28Dec2020 09:15 at single dose on left arm (Lot number: ek9231) for COVID-19 immunisation. Medical history included asthma, bronchitis, mitral valve regurgitation, herpes, depression, ADHD. COVID prior vaccination: Yes. Known allergies: tramadol, milk products. No other vaccine in four weeks. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), bupropion, and, losartan/hydrochlorothiazide. The patient experienced red palms/blotching, sweating profusely, heart palpitations, chest pain and fainting, elevated BP, all on 28Dec2020 09:15. All these events required Emergency room visit. Therapeutic measures were taken as a result of the events included 50 mg of Benadryl, 60 mg of Prednisone, omepresol. No COVID tested post vaccination. Outcome of events was recovered with sequelae.
46 2021-01-06 chest pain I had abdominal cramps, generalized that lasted for two days. On the second day, went to ER. Then on... Read more
I had abdominal cramps, generalized that lasted for two days. On the second day, went to ER. Then on the 3rd and 4th day, I had chest pain radiating to left arm and jaw. Fever and chills reported 100.2 in fever. Severe right arm pain. I have difficulty lifting objects. I have recovered from the chest pain and abdominal pain but the arm pain is still bothersome and continues to be hurtful.
46 2021-01-06 chest pain Myalgia chest pain, bronchial spasm Narrative:
46 2021-01-06 blood pressure increased Pfizer vaccine 12/19. Reports intermittent dizziness, brain fog, severe headaches, nausea, shortnes... Read more
Pfizer vaccine 12/19. Reports intermittent dizziness, brain fog, severe headaches, nausea, shortness of breath, left axillary lymphadenopathy, elevated blood pressure which onset on 12/31. COVID-flu negative, normal labs, CT thorax and brain MRI negative. Has been to ED and is returning today due to continued symptoms. Reported symptoms to VSafe
46 2021-01-06 heart rate increased, chest discomfort Received the Vaccine on a Monday morning, Next day started with a bad cold. By Tuesday night I had... Read more
Received the Vaccine on a Monday morning, Next day started with a bad cold. By Tuesday night I had to use my inhaler, take cold/cough medicine to help me stop coughing. By Wednesday Had a bad cough, tightness in the chest, and lots of congestion. Left arm was very sore. Called work who told me to go to the ER for covid test. Tried to get into my doctor's office who would not see me and told me to get a covid test. Tried to get into Facility who told me I would require two appointments. One to see a doctor and another to get a Covid test. Also, it would be a three to four-hour wait. Felt so sick that I took myself to an ER in order to be seen. Mysaturation was good in the ER but HR was in the 120s. They did an EKG, gave me an albuterol inhaler, IV fluids, IV steroids, and a chest X-ray. They did a Covid test which was negative as well as other bloodwork. Then sent me home. My husband also started with a cold the Sunday night before my vaccine so I do not know if that might have been where I got sick?
46 2021-01-06 heart rate increased Tingling in arm, vision was blurry, Dizziness, difficulty breathing, head spinning. Weakness, body a... Read more
Tingling in arm, vision was blurry, Dizziness, difficulty breathing, head spinning. Weakness, body aches, fast heartbeat. Speech slurred, jaw locking. Taken to ER where she works.
46 2021-01-06 pallor Within 30-45 minutes after injection, became ill with extreme dizziness, facial/neck swelling, skin ... Read more
Within 30-45 minutes after injection, became ill with extreme dizziness, facial/neck swelling, skin pale, diaphoretic, c/o nausea with vomiting x1. Taken to ED. Treated with Benadryl 50mg IV, Zofran 4mg SL, meclizine 25mg PO, and 1 liter of 0.9% Normal Saline IV. Symptoms improved, discharged to home at 6pm.
46 2021-01-06 palpitations jaw tightening; muscle spasms; entire face and around her mouth went numb; entire face and around he... Read more
jaw tightening; muscle spasms; entire face and around her mouth went numb; entire face and around her mouth went numb; heart palpitations; I had hives on my chest; a wave of heat rush up her back; This is a spontaneous report from a contactable nurse (patient). A 46-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration in left arm on 22Dec2020 10:30 at first single dose for COVID-19 immunization. Medical history included ectopic pregnancy, hay fever. Concomitant medication received within 2 weeks included: loratadine, colecalciferol (vitamin D), olly womens multivitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No known allergies. About 15 minutes after the vaccine the patient experienced jaw tightening and muscle spasms. The patient was given oral Benadryl 50 mg. About 5 minutes after taking the Benadryl, her entire face and around her mouth went numb. The patient began having heart palpitations and felt a wave of heat rush up her back. She had hives on her chest. The patient received 1 dose of epinephrine from an Epi-Pen and transported to the emergency room for further treatment. Adverse event start date: 22Dec2020 11:00 AM. Events were considered as non-serious. Events resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Treatment received for the adverse event included: Benadryl, Epinephrine, Solumedrol, Pepcid. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. Test Name: SARS-CoV-2 by PCR (Nasal Swab) on 30Dec2020: Negative. Outcome of the events was not recovered.; Sender's Comments: The temporal relationship is suggestive of an acute anaphylactic reaction. Based on the temporal relationship and the known pattern of response, the vaccination with BNT162B2 might play a contributory role in triggering the onset of the reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
46 2021-01-07 chest discomfort Chest tightness, headache, runny nose, mild cough.
46 2021-01-07 chest discomfort Shortly after receiving vaccination, patient experienced chest pressure, shortness of breath, feelin... Read more
Shortly after receiving vaccination, patient experienced chest pressure, shortness of breath, feeling jittery and shaky. Oxygen saturation remained normal. Vital signs normal.
46 2021-01-09 heart rate increased, chest discomfort, blood pressure decreased 15 minutes and 21 seconds after shot was given, I felt suddenly very hot, lightheaded and I could fe... Read more
15 minutes and 21 seconds after shot was given, I felt suddenly very hot, lightheaded and I could feel my pulse escalating. Nurse in the post-shot monitoring tent took vitals to confirm pulse at 95, when typically 68. I was laid down and BP dropped to 110/78. Chest tightness that I am familiar with from asthma started to develop and my neck and throat and upper shoulders felt very tight and constricted. I had some trouble swallowing water as though my throat was constricted and my breathing felt shallow. Nurses provided care and I was asked to get up and sit in a chair again. Within a minute, I felt dizzy and disoriented again and heart rate went up. The tightness in my chest and throat and shallow breathing continued along with my voice becoming hoarse. The doctor on call asked if I?d had these symptoms before and I said I had after eating shrimp years ago. He decided to transfer me to the ER for monitoring . I stayed at the ER for about an hour and a half and was monitored. The constricted throat and asthma chest tightness did not subside but did not get worse. Doctor recommended Benadryl every 6 hours as symptoms persisted. Within a half hour of taking 25 mg of Benadryl, I started to feel improved breathing and less throat constriction and easier swallowing. After the second dose of Benadryl, symptoms were much 70% gone, except for hoarse voice abs very slight tightness with swallowing. I had informed the injection staff prior to receiving my vaccine that I am a person with a history of anaphylaxis (not to a vaccine) that required and epi pen and overnight hospital stay in the past .
46 2021-01-09 palpitations Sore to injection site-first day Palpitations up to 120bpm in resting lasting 4-5 hours-second day
46 2021-01-09 heart rate increased Tightness, tenderness in thyroid area across the throat/lowest part of front of neck (not airway con... Read more
Tightness, tenderness in thyroid area across the throat/lowest part of front of neck (not airway constriction but on the outside). Severe heartburn, burping and reflux, anxiety, slightly elevated heart rate about 30 mins after injection, lasting about 30 mins. 5 hours after injection, after eating a small snack, repeat of heartburn, burping and reflux. Felt hot but temperature 97.7, then chills briefly. Anxiety and related fast heart beat and shallow breathing for about 1 hour. Took benadryl, no change.
46 2021-01-10 chest discomfort, troponin increased, palpitations, hypertension, heart rate increased About 5 min after receiving vaccine - had just sat down after vaccine and had a weird sensation: lik... Read more
About 5 min after receiving vaccine - had just sat down after vaccine and had a weird sensation: like felt like rushed through my body and then instantly my heart started racing and I felt it thump into my throat. Let nurse in attendance know and she took me to another area secluded from others and told me to relax. Sat down. Hooked me up to monitors; blood pressure cuff and finger pulse and she left to go get someone and she brought EMT back with her. Felt tight in chest; in neck felt like there's tightening; but could still breathe; felt heavy: chest. Neck felt tight. Felt like I needed an inhaler. I don't have it with me as I only have asthma in spring and fall. They kept telling me to calm down and I wasn't feeling nervous. I was trying to relax. EMT asked questions and he said that the same thing happened to him. He told me I couldn't leave Event Center until things calmed down for me. Released her when I felt fine but was just really tired and kind of shaky. I felt so exhausted. Told EMT that and he told me he would feel that way if he had just ran a marathon. I had slept 12 hours the night before. He didn't tell me what my heartrate went up to. I left event center at 9:49 pm. Started feeling strange again when doing errands and was at store afterwards (about 30 or 40 min later) - nauseous; dizzy; sweaty, clammy. Heart was racing again. I told husband I didn't feel right. Felt like I needed to sit because I was shaky. Left and went to vehicle. As we sat in car, I told him something wasn't feeling right. Mouth was so dry. He started driving. I felt like we were driving down a tunnel.Husband looked at me and said you don't look right either. Took me to ER in nearest hospital: blood pressure high; heart rate elevated; ER (Hospital) The doctor did lab work. Triponin levels elevated; potassium levels low - sign of a heart episode and needed to get in control. Gave me potassium and took more blood work and troponin levels started coming down. Dr advised me not to go back to get second dose. Personal Care Dr confirmed that I shouldn't get the 2nd dose - put in my records that I am allergic to this vaccine. The next day I had severe diarrhea and terrible pain in my arm that went all the way down and up into my neck and whole right side head hurt. (really bad headache). Extreme fatigue. Went back to work on the following Monday evening and was exhausted doing my job. When I say family Dr on Tuesday, I didn't want to be taken off work because I was in the right place where people could take care of me and I'd taken time off at holidays. That entire week was a lot of exhaustion and tiredness.
46 2021-01-10 chest pain, blood glucose increased Pfizer COVID-19 Vaccine A couple hours after the vaccination the patient experienced pain in the v... Read more
Pfizer COVID-19 Vaccine A couple hours after the vaccination the patient experienced pain in the vaccine arm, headache, and feeling ache. Day 1 post vaccination patient experienced sore arm, headache, low grade fever, feeling ache, and GI symptoms with diarrhea. Day 2 post vaccination patient experienced sore arm, Migraine, and diarrhea. Day 3 post vaccine patient woke up with chest pain that radiated into her left arm and some weakness. Patient's blood sugar was >500 and was admitted to hospital for DKA.
46 2021-01-10 palpitations The patient began to experience heart palpitations about 10 minutes after receiving the Pfizer COVID... Read more
The patient began to experience heart palpitations about 10 minutes after receiving the Pfizer COVID vaccine (first dose). The HR was checked and marked to be 110bpm. The pt then began to experience tingling at the injection site as well as in the lower bilateral extremities. The pt was escorted to the holding area to lie down on the stretcher. VS checked (139/89 BP, HR 95, Temp 98.4, O2Sat 100%.). Dr in the ACC was called to assess and observe the patient. No further recommendation for treatment was given. Patient was observed for a total of thirty minutes. HR remained within normal limits and pt was cleared to be discharged to home safely. Pt ambulated to personal vehicle with nurse escort.
46 2021-01-11 chest pain Headache, body aches, fever over 100, fatigue, chills, sharp pain occasional in same area of chest u... Read more
Headache, body aches, fever over 100, fatigue, chills, sharp pain occasional in same area of chest upper left side. when i would shift to laying flat, pain would go away.
46 2021-01-12 chest pain 1/9/21 at 1030pm began with chest pain, chills, sweats, fever 101, body aches, joint pain, headache,... Read more
1/9/21 at 1030pm began with chest pain, chills, sweats, fever 101, body aches, joint pain, headache, fatigue. Took tylenol and slept. Next morning, 1/10/21,w oke up at 10am, fever 102, continued with chills, sweats, body aches, joint pain, headache, fatigue and began with intermittent SOB. Took tylenol and slept most of the day and night. Next day, 1/11/21, temp 100.8, continued with chills, sweats, body aches, joint pain, headache, fatigue, intermittent SOB and chest pain. Continued to take tylenol and alternated with ibuprofen. Rested most of the day in bed. 1/12/21, no fever, intermittent SOB with activity, continue with headache and joint pain. 1/13/21 better today. Continue with intermittent SOB with activity and feel fatigue. No fever.
46 2021-01-12 loss of consciousness, heart rate increased Around 11:30pm on 1/12/2021, began having pretty serious chills (fever not measured but felt very wa... Read more
Around 11:30pm on 1/12/2021, began having pretty serious chills (fever not measured but felt very warm). At about 1:45am on 1/13/2021, was feeling very achy and uncomfortable, so I went downstairs to get some Tylenol. Rapid heart rate and sweating, so much I had to sit down in the kitchen for a few minutes. Eventually took the Tylenol, and as I was heading back upstairs, I passed out (I don't remember going down to the floor) and dropped the cup of water I was taking with me. Was out for less than 30 seconds. A couple episodes of heaving/vomiting small amounts of liquid while on the floor. Made it back to bed and was starting to feel improved around 4:00am.
46 2021-01-12 loss of consciousness, heart rate increased Around 11:30pm, I woke up with incredible chills and had them for about 1.5 hours. Around 1:45am/2:0... Read more
Around 11:30pm, I woke up with incredible chills and had them for about 1.5 hours. Around 1:45am/2:00am on 1/13/2021, aches began, so I went downstairs to take acetaminophen. Increased heart rate and sweating while in the kitchen (had to sit down on the floor), eventually took Tylenol, and as I was heading back upstairs with cup of water, I passed out (less than 30 seconds) dropping the cup of water. Heaved/vomited small amount of liquid two or three times. Made it back to bed and began to feel better around 4:00am 1/13/2021.
46 2021-01-12 chest discomfort, palpitations Palpitations; Chest pressure; Lightheadedness; Nausea; This is a spontaneous report from a contactab... Read more
Palpitations; Chest pressure; Lightheadedness; Nausea; This is a spontaneous report from a contactable nurse (patient). A 46-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on 23Dec2020 14:15 at left arm, at single dose for covid-19 immunization. Medical history included history of seizure, known allergies: topical Sulfa. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included (ascorbic acid) (VITAMIN C), (sambucus nigra) (ELDERBERRY), (linum usitatissimum seed oil) (FLAXSEED OIL), (allium sativum) (GARLIC). The patient previously took lamotrigine (LAMICTAL) and known allergies: LAMICTAL. The patient was not pregnant at the time of vaccination. The patient experienced palpitations, chest pressure, lightheadedness and nausea on 23Dec2020 14:15. The patient received Zofran and Meclizine given. Event resulted in: Emergency room. The outcome of the events was recovered on an unspecified date. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No seriousness criteria: no Results in death, no Life threatening, no Caused/prolonged hospitalization, no Disabling/Incapacitating, no Congenital anomaly/birth defect. Information on the lot/batch number has been requested.
46 2021-01-12 palpitations Right after I received the vaccine, like 2 minutes latter, I started feeling dizzy, then I had a sho... Read more
Right after I received the vaccine, like 2 minutes latter, I started feeling dizzy, then I had a shocking sensation around my throat then I had some palpitation.I better about 20 minutes latter. I had prednisone at home, so I took 40mg and Benadryl and PepciI felt I had some sensation of throat tightness the day after that but it went away after few hours.
46 2021-01-12 chest discomfort TIGHTNESS OF CHESS, FEELS LIKE I AM GOING TO GET AN ASTHMA ATTACK. SOME COUGHING DIZZINESS
46 2021-01-12 blood pressure increased, heart rate increased The day after I received a vaccine, I had higher than usual blood pressure and pulse rate. I also ha... Read more
The day after I received a vaccine, I had higher than usual blood pressure and pulse rate. I also had a muscle pain in the arm and I felt tired during the day and in the evening. My pulse rate continues to be high. My pulse rate was 100 on the second day and for number of days it is around 95. Today it was 95 most of the day. I have not been regularly checking my pulse rate before, but based on what I found in some information in my medical record, it is most likely around 75. I notice the higher pulse rate through pulsation in the chest and temples. I have a hard time concentrating on work and reading things on the screen.
46 2021-01-12 fainting headache nausea syncope
46 2021-01-14 chest discomfort Left arm went total numb for over 72 hours; Red and swollen all the way up to the shoulder; Red and ... Read more
Left arm went total numb for over 72 hours; Red and swollen all the way up to the shoulder; Red and swollen all the way up to the shoulder; Red and swollen all the way up to the shoulder; Tighten in chest; Weakness; dizziness; Slept for over 24 hours; Nausea; vomiting; This is a spontaneous report from a contactable other Health Professional (HCP) (patient). A 46-year-old non-pregnant female patient received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ek9231), via an unspecified route of administration on 07Jan2021 14:30 at single dose in her left arm for covid-19 immunization. Medical history included dermatitis contact and asthma. The patient had allergies to medications, food, or other products. The patient did not receive any other medications within 2 weeks of vaccination. The patient previously received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ek5730) at single dose in her left arm on 17Dec2020 14:30 for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. The patient experienced feft arm went total numb for over 72 hours, red and swollen all the way up to the shoulder, tighten in chest, weakness and dizziness, slept for over 24 hours, nausea and vomiting on 08Jan2021 04:30. The events result in doctor or other healthcare professional office/clinic visit. The patient received prednisone 100 mg to treat these events. The outcome of the events was recovered in Jan2021.
46 2021-01-15 palpitations Pfizer-BioNTech COVID-19 Vaccine: Within fifteen minutes of vaccination patient reported chest and f... Read more
Pfizer-BioNTech COVID-19 Vaccine: Within fifteen minutes of vaccination patient reported chest and facial flushing , mild facial swelling, and feeling of heart racing. Initial vital signs: blood pressure 117/58 mmHg, pulse 91 beats per minute, and oxygen saturation 97% on room air. Patient administered oral diphenhydramine 50 mg once and observed for a total of one hour from vaccine administration during which symptoms improved. Vital signs were checked every five minutes and remained within normal ranges during entire observation period. Patient given water and juice and left in stable condition.
46 2021-01-16 heart rate increased 24 hours after 2nd dose my heart rate was elevated at an abnormal rate for more than 24 hours. The h... Read more
24 hours after 2nd dose my heart rate was elevated at an abnormal rate for more than 24 hours. The highest I recorded was 104 at resting. My normal is 74. I felt tired but wired and started recording it on my smart watch. After 48 hours it returned to more of a normal rate but still continues to be more elevated than before. I will follow up with my PCP this week. I had other symptoms that seemed normal-headache, chills, exhausted, sore arm, etc.
46 2021-01-16 chest pain Sudden, intense pain in the mid sternum just to the left side. She recalls some dull vague pain ove... Read more
Sudden, intense pain in the mid sternum just to the left side. She recalls some dull vague pain over the past night, but the sudden pain developed about 3 minutes before I came into her office. Pain was a 10/10 in severity and made it difficult to breathe and talk. She was able to tolerate snow blowing this morning without notable difficulty. Pain is not clearly exertional in nature.
46 2021-01-17 blood pressure increased I developed acute wheezing, thorat tightening and tongue nubness. I got 50 mg Benadryl and 4 puffs ... Read more
I developed acute wheezing, thorat tightening and tongue nubness. I got 50 mg Benadryl and 4 puffs ALbuterol and monitored by EMTS for 30 mins more. I had sl elevated BP 148/86 and pulse ox at 97% and HR 95. Symptoms improved 20 min after Benadryl so I was released hom as I had my own epi pen and was a doctor so could self monitor.
46 2021-01-18 palpitations, chest discomfort 1/12: Immediately after receiving vaccine felt pressure and flushing in face which progressed to sen... Read more
1/12: Immediately after receiving vaccine felt pressure and flushing in face which progressed to sensation of tightness in chest and throat but no dyspnea, able to talk, no change in MS. Evaluated by PA - Code Green called. VS stable, transferred to ICU> In ICU labs completed, monitoring continued - all stable. Ate sandwich without difficulty or N/V. discharged to home 1/13: Had continued sensation of numbness and tingling in tongue that night and metallic taste in mouth with fatigue and headache. Aprox 11am 1/13 developed racing heart , increased numbness and tingling in tongue and metallic taste in mouth. Called 911 - transferred to different hospital. Evaluation including EKG completed without finding. Symptoms gradually resolved - discharged how with instruction to f/u with PCP. 1/14 - Home/stable, mild change in sensation in mouth and tongue persist otherwise tolerating all activity, working from home without difficulty.
46 2021-01-18 fainting Fainted, chills sweating bodyaches and extremely bad headache
46 2021-01-18 hypertension, fast heart rate Pain and numbness on L forearm near the injection site Mild hypertension and tachycardia
46 2021-01-19 chest discomfort Itching face/back-5 minutes after. tightness in throat-10 minutes after. fullness in ears- 30 min... Read more
Itching face/back-5 minutes after. tightness in throat-10 minutes after. fullness in ears- 30 minutes after. Taken to ER approximately 25-30 after injection for evaluation. Symptoms not escalating, eventually treated with Benadryl, steroids and Pepcid, held briefly for observation, released with Claritin and steroid prescription to take for the next few days. I was instructed to premedicate for the 2nd dose. Approximately 5-6 hours after dose developed tightness in chest, tingling face/lips/mouth/fingers. Symptoms persist still, self medicating with Benadryl and klonapin.
46 2021-01-20 chest discomfort Employee experienced shortness of breath, chest tightness, nausea and headache after vaccination and... Read more
Employee experienced shortness of breath, chest tightness, nausea and headache after vaccination and needed prolonged monitoring post vaccination. Improved with rest.
46 2021-01-20 chest pain Occasional chills; mild chest pain with deep breath; mild chest pain with deep breath; This is a spo... Read more
Occasional chills; mild chest pain with deep breath; mild chest pain with deep breath; This is a spontaneous report from a contactable consumer (reporting for a patient). A 46-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date were not reported), via an unspecified route of administration on the left arm on 08Jan2021 12:00 at a single dose for COVID-19 immunization. There was no other medical history, had no known allergies. Concomitant medications were not reported. The patient did not have COVID and did not receive other vaccine in four weeks prior to vaccination; did not have other medication within two weeks and was not pregnant at the time of vaccination. On 08Jan2021, the patient experienced occasional chills and mild chest pain with deep breath. No treatment was given for the events. The patient has not been tested for COVID post-vaccination. Outcome of the events was recovered on an unspecified date. Information on the lot/batch number has been requested.
46 2021-01-20 chest discomfort Patient developed one singular area of urticaria approximately one hour after the vaccination and th... Read more
Patient developed one singular area of urticaria approximately one hour after the vaccination and then developed an anaphylactoid reaction 3 days later including widespread urticaria and chest tightness. She took OTC antihistamines and recovered 6 days after the vaccine.
46 2021-01-20 nosebleed nose hemorrhage for four days
46 2021-01-21 pallor Chills, myalgia and fatigue starting around 12 hours after vaccine dose. Nausea, photophobia and fe... Read more
Chills, myalgia and fatigue starting around 12 hours after vaccine dose. Nausea, photophobia and fever starting around 24 hours after vaccine dose, subsiding with medication after about 8 hours. Diarrhea and blanching red rash at chest, shoulders and back starting 48 hours after vaccine dose.
46 2021-01-21 heart rate increased allergic reaction; patient was experiencing being flushed; fast heart rate; she wasn't feeling well ... Read more
allergic reaction; patient was experiencing being flushed; fast heart rate; she wasn't feeling well a few minutes after receiving it; her throat felt thick; had trouble swallowing; This is a spontaneous report from a contactable other HCP and pharmacist. A 46-year-old female patient received the first dose of BNT162b2 (lot: EL3247, Expiry Date: May2021), via an unspecified route of administration in left arm on 15Jan2021 at 0.3 mL, single for covid-19 immunization. Medical history included food allergic. The patient's concomitant medications were not reported. The patient experienced allergic reaction on 15Jan2021. The patient alerted she wasn't feeling well a few minutes after receiving vaccine. The patient was experiencing being flushed, had a fast heart rate, and her heart rate kept increasing over time, despite two benadryl, the patient had allergic reactions in the past due to food, so the patient knew what it felt like, so could expect it, so the patient spoke up soon, and the Epipen was given 28-30 minutes later, and after that, the patient said her throat felt thick and she had trouble swallowing, so was taken to the hospital. The patient seemed to be getting worse, after time, after the Epipen. The patient was most likely admitted to the hospital. The outcome of the events was not recovered.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of reported events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
46 2021-01-22 heart rate increased, palpitations On 1/17/2021 @ approximately 1130, I ran upstairs and began experiencing extreme shortness of breath... Read more
On 1/17/2021 @ approximately 1130, I ran upstairs and began experiencing extreme shortness of breath, dizziness and increased heart rate with what felt like palpitations, as well as a massive headache. The symptoms resolved subsided after 10 minutes, but returned again shortly afterwards. After taking some Advil 200mg x 1, my symptoms improved but I still remained fatigued and had difficulty breathing at 100% the rest of the day. After the 2nd episode 911 was contacted and FD arrived at my home. All vital signs, pulse & O2 were WNL, except BP @ 153/99. I've had one previous experience with this and it was while taking Izoniazid as a TB prophylactic after a 6 month treatment. As of today, my symptoms have resolved and am back to my usual state.
46 2021-01-22 palpitations patient went back to the procedure center after receiving vaccine after 15 min observation and compl... Read more
patient went back to the procedure center after receiving vaccine after 15 min observation and complained of N, abdominal pain and out of body experience with inability to talk or describe what happened. Palpitations. No CP, SOB, wheezing or visual changes. HR 140's w occ PVCs, SBP 160-170's SpO2 100% with pt appearing flushed and drowsy. O2 NC, NS 1 liter IV, zofran 4mg IVP x1 given. Admitted to procedure center at 1500 and discharged at 2359.
46 2021-01-24 chest pain, fast heart rate Approximately 5-10 minutes after 1st dose of vaccine, patient complained of feeling sweaty, nauseous... Read more
Approximately 5-10 minutes after 1st dose of vaccine, patient complained of feeling sweaty, nauseous, and not feeling right. She was tachycardic and bradycardic soon after. She was transported to the ED for evaluation. She endorsed lightheadedness, chest pain, and trouble swallowing upon ED triage. She was given diphenydramine 25mg PO x 1 dose and observed for ~2.5 hours prior to discharge.
46 2021-01-24 palpitations Individual started to feel her heart begin to race. she said she felt a little light-headed and her... Read more
Individual started to feel her heart begin to race. she said she felt a little light-headed and her vision was "off". She had a headache coming to the clinic which she had taken excedrine for prior to arriving. We took her blood pressure about 10 minutes after vaccination and it was 150/88 HR 130. We moved her into a private room to monitor and attempt to relax her. continued BP monitoring every 5-10 minutes- 148/92 147, 160/90 155. She stated that her left lip felt tingly so at that time we decided to call 911.
46 2021-01-24 chest discomfort Itching bilateral hands, feeling warm for 2-3mins, anxiety, flushed ,Headache received Benadryl 25m... Read more
Itching bilateral hands, feeling warm for 2-3mins, anxiety, flushed ,Headache received Benadryl 25mg orally and chest tightness and heaviness received 2nd dose Benadryl 25mg . EMS /cardiac monitored and was transferred to a Hospital.
46 2021-01-24 chest pain fever/had a 100.1 degree fever/temperature over 100.1; Sore ARM/Injection site; Headaches/massive he... Read more
fever/had a 100.1 degree fever/temperature over 100.1; Sore ARM/Injection site; Headaches/massive headache; eye pressure/Pressure in eyes; Body aches; Muscle spasms/Cramping; tired/tiredness/fatigue/feeling rundown; hot and cold chills; tremors; coughing; chest pain; swelling; unable to work; This is a spontaneous report from a contactable consumer (patient). This 46-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EK9231), via intramuscular on 06Jan2021 09:45 at single dose on left arm for COVID-19 immunization. The patient's medical history included asthma, arthritis and COVID-19. No known allergies. The patient's concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (lot number EH9899) on 16Dec2020 09:45 at single dose for COVID-19 immunization. Facility type vaccine was workplace clinic. Patient was not pregnant. No other vaccine received in four weeks. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Patient was a PCT Patient Care Technician. Patient had not been feeling well/sick on 06Jan2021 since receiving her second vaccine dose. Patient said she was unable to work, and was still feeling sick. Patient experienced massive headaches, pressure in eyes, body aches, sore arm/injection site, muscle spasms/cramping, tired/tiredness/fatigue/feeling rundown, hot and cold/chills on 06Jan2021 11:00. These adverse events resulted in Doctor or other healthcare professional office/clinic visit. Patient stated she had reactions coughing, chest pain, swelling, tremors in Jan2021. Patient said she couldn't bend without having a muscle spam. Patient clarified if she tries to wipe herself after she goes to the bathroom, she has muscle cramping. Patient clarified if she tries to turnover in bed, she has charley horses everywhere. Patient reported walking hurts from having so many charley horses. Patient said the headache seemed like it was progressing. Patient was feeling rundown and tired. Patient reported she had hot and cold chills over the weekend. Something didn't feel right on 11Jan2021, so she took her temperature and she had a 100.1 degree fever. Patient clarified she did not check her temperature prior to 11Jan2021. Patient reported she has been taking ibuprofen 800mg to maintain herself as treatment. She said she took some of the ibuprofen 800mg over the weekend, and then decided to take her temperature on 11Jan2021, and that was when she discovered she had a fever. Reported the ibuprofen 800mg was a prescription from her doctor and was dispensed in an amber pharmacy bottle. Patient stated she had lab work for, because of COVID her lungs has been messed up but before she had the shot she was doing pretty good. So, she would be getting tested periodically for her lungs and all that because she had COVID at one time. Patient stated the doctors gave her prednisone and antibiotics as treatment. For antibiotics name, Patient stated amoxycillin she believed it was and the doctors gave her another pill start with a M for swelling. Patient stated her doctor did said it had nothing to do with concomitant medication and other medication conditions. The doctor said it had to do with having the shot. Treatment for adverse events (headaches, pressure in eyes, body aches, sore arm/injection site, muscle spasms, cramping, tired, fatigue, temperature over 100.1, hot and cold/chills) included penicillin, amoxicillin, prednisone. Outcome of massive headaches, pressure in eyes, body aches, sore arm/injection site, muscle spasms/cramping, tired/fatigue, temperature over 100.1, hot and cold/chills were not recovered, outcome of other events was unknown.
46 2021-01-24 chest discomfort wet and cold sensation on chest; she would have a heard time falling asleep or get no sleep at all t... Read more
wet and cold sensation on chest; she would have a heard time falling asleep or get no sleep at all that night; Breast discomfort/describes the breast discomfort as a contracting feeling of encapsulation; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EH9899) injection intramuscularly in right arm on 21Dec2020 around 11:00 am at a single dose of COVID-19 immunization. Vaccination facility type was at medical center. Relevant medical history included acne, migraine, and chronic neck and upper back pain; all were ongoing, and breast implant, tennis elbow in left arm and she had the flu shot in Oct but she never got any reaction. She thought a side effect of spironolactone. Concomitant medications included rizatriptan benzoate (MAXALT, strength: 5mg, tablet) at 5mg tablet as needed for migraine, naproxen sodium (ALEVE, strength: 500mg, tablet) at 500 mg tablet, one tablet as needed for pain, and spironolactone (strength: 5mg tablet) (if her skin was breaking out she will take two tablets that night and if her face was not bad she will take one tablet) from Aug2020 for acne, breaking out; all were ongoing. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was reported as none. Additional vaccines administered on same date of the Pfizer suspect was reported as none. Prior vaccinations within 4 weeks and AE(s) following prior vaccinations were reported as none. On 26Dec2020 she started feeling breast discomfort. She described the breast discomfort as a contracting feeling of encapsulation, reported it kept her up at night, she would have a heard time falling asleep or get no sleep at all that night. Her breast comfort started to lessen. The patient was breast discomfort or tenderness but she did not experience any breast discomfort till after she got the covid vaccine. She stated the breast discomfort was like a feeling that something was crawling inside, states it is like creepy crawlers. She also experienced a wet and cold sensation on her chest on 29Dec2020 and was still occurring once in a while, intermittently. At first it was just on the left breast, and the next night she felt the sensation across her chest, it felt like she spilled water and felt wet but it was not wt. She felt it while she was bed. She had breast implants. Last week she contacted her primary care doctor and she was sent to get a mammogram and ultrasound. She went to have the mammogram and ultrasound on Friday 08Jan2021 and everything was fine. She was thinking what she was experiencing was from the vaccine. The patient declined any treatment. No emergency room and no physician office required for the events. The outcome of event breast discomfort was resolving, of wet and cold sensation on chest was unknown.
46 2021-01-25 blood pressure increased Felt warm and flushed with elevated Blood Pressure
46 2021-01-25 chest discomfort Fever Cough Fatigue Malaise Headache Dizzy Weak Tight chest/short of breath Generalized discomfort J... Read more
Fever Cough Fatigue Malaise Headache Dizzy Weak Tight chest/short of breath Generalized discomfort Joint discomfort
46 2021-01-25 chest discomfort PVCs started after the first COVID19 Pfizer vaccine. They were frequent, had associated symptoms of ... Read more
PVCs started after the first COVID19 Pfizer vaccine. They were frequent, had associated symptoms of chest discomfort and breathlessness, and I went to the doctor. Their frequency/severity trended toward improving, but after the 2nd vaccine I was back to their original intensity/frequency. I do not have a history of similar. They are affecting my daily life. I've been referred to a Cardiologist.
46 2021-01-25 fainting, palpitations, heart rate irregular, chest pain Saturday, 01/09/21 1300-received 2nd vaccine Sunday, 01/10/21 0500 -severe left arm pain, began at i... Read more
Saturday, 01/09/21 1300-received 2nd vaccine Sunday, 01/10/21 0500 -severe left arm pain, began at injection site, radiated: up and across L shoulder blade area, up neck and into head, down to L fingertips 0600 -all above continued, R knee joint pain (sharp/stabbing) 1400 -all above continued except R knee joint pain; spinal pain and intercostal pain began 1900 -all above continued; TMJ, jaw, and 'tooth' pain began Monday, 1/11/21 TMJ, jaw, and 'tooth' pain, nausea, fatigue, night sweat Tuesday, 1/12/21 TMJ, jaw, and 'tooth' pain, nausea, fatigue, night sweat Went to dentist (scheduled appointment on Monday) for cleaning and thorough exam...exam was normal Wednesday, 1/13/21 continuation of symptoms from 1/12/21, but pain worse, ear pain Thursday, 1/14/21 0630 had eaten a full can of chicken noodle soup. Was sitting and working on CEs for work, had taken medications for the day, but added in hydrocodone, half of a 7.5/325mg tablet and ibuprofen 200mg. Felt a severe wave of nausea. Laid my head down on my arms on the table. Do not remember getting up, but remember walking through the kitchen in front of the refrigerator, reaching up to feel my pulse, felt two beats which were too far apart and thought to myself, "I'm going to faint". Apparently I was able to walk about 6 feet further, but I don't remember it. I don't know what time I fainted, but I think I must have fallen. I woke up sometime after 7, disoriented and my head hurt, lying on the kitchen floor. My husband came to my side after I called out to him about 5 times. I was drenched in sweat and very weak. When firefighters arrived they said my heart rate was 'all over the place', from 46 to I don't know what (did not hear). Ambulance arrived around 0730. Glucose was normal. Was taken for evaluation. Was given IV NS (I think 1000mls). Labwork was drawn. CXR, CT, and EKG. ER Dr recommended I follow up with my cardiologist, as she noted mitral valve regurgitation and thought a Holter monitor would be advisable. CXR and CT normal. EKG normal sinus rhythm, but showed anteroseptal infarct of unknown age, confirmed by cardiologist who read the EKG. Also seen by my PCP at 1430, he checked my ears, as they had been hurting as well, said they were clear. Advised alternating tylenol and ibuprofen Q4-6H. Friday and Sunday 1/15 and 1/16 night sweat, TMJ pain, nauseated, headache, neckache, fatigue, shoulders sore, eyes sore, inner ear pain Sunday, 1/17 0500 woke up, lying in bed, dizzy, clammy palms, chest pain (mid-clavicular, just below left breast, stabbing), night sweat, TMJ pain, nauseated, headache, neckache, fatigue, L & R flank pain, BP 115/70, HR 54 Monday 1/18, Tuesday, 1/19, Wednesday 1/20, Thursday 1/21, Friday 1/22, and Saturday 1/23 varying degrees of: fatigue, nausea, dizziness, TMJ, jaw, and 'tooth' pain, palpitations, and ear pain. TMJ and jaw pain worsens with activity.
46 2021-01-26 chest pain, chest discomfort Chest tightness/ heaviness ( like an elephant sitting on my chest ), severe headache , and ringing i... Read more
Chest tightness/ heaviness ( like an elephant sitting on my chest ), severe headache , and ringing in ears began about 1 hour after vaccine given. Fever greater than 102 / chills began about 2 hours after vaccine given. Severe body aches, nausea, and extreme fatigue, extreme weakness, dizziness, and chest pain when taking a deep breath began within 4 hours after vaccine.
46 2021-01-26 heart rate increased tunnel vision; 2 minutes after injection Heart rate went to 138/Hr 110/elevated heart rate.; dizzine... Read more
tunnel vision; 2 minutes after injection Heart rate went to 138/Hr 110/elevated heart rate.; dizziness; This is a spontaneous report from a contactable nurse reporting for herself. A 46-years-old female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, Lot number Ek9231, via an unspecified route of administration in left arm on 28Dec2020 at 11:45, at 46 years of age, at single dose for COVID-19 immunization. The patient was not pregnant when she was vaccinated and received the vaccine in Hospital. She didn't receive any other vaccine in the previous 4 weeks. Medical history included Meniere's disease with sudden hearing loss in left ear from an unknown date, gastrooesophageal reflux disease from an unknown date and allergy to penicillin and sulfa drugs. Concomitant medication included famotidine (PEPCID), paracetamol (TYLENOL), ergocalciferol (VITAMIN D) supplements and cetirizine hydrochloride (ZYRTEC). On 28Dec2020, 2 minutes after vaccine injection, the patient experienced tunnel vision, assessed as medically significant, her heart rate went to 138 and she experienced dizziness. The same happened again "at the 8 min mark": heart rate at 110 and dizziness. The events resolved on their own. Dizziness and elevated heart rate happened again later that evening. At the time of the report the reported events had resolved without any treatment.; Sender's Comments: Based on the compatible time association, the events tunnel vision, heart rate increased and dizziness are reasonably related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
46 2021-01-28 chest pain The pressure like midsternal pain started on 1/28/2021 around 10:00, I was standing. It came on and ... Read more
The pressure like midsternal pain started on 1/28/2021 around 10:00, I was standing. It came on and went away throughout the day. I woke up on 1/29/2021 and about 11:00 I started having the same pain again. I am more tired today. I have problems with acid reflux in the past usually after eating too much or during my menstrual cycle. I have been seen in hospital recently prior to covid vaccine and my heart is very great. I don't smoke or drink alcohol, no illicit drugs. I took Prevacid, it didn't help. The pain comes and goes with no aggravating or relieving factor.
46 2021-01-28 chest pain pulsing squeezes/pulsing feeling periodically; I felt tingly; lightheaded; a little hot; felt stiff ... Read more
pulsing squeezes/pulsing feeling periodically; I felt tingly; lightheaded; a little hot; felt stiff in neck; a little aching in shoulder/chest area; a little aching in shoulder/chest area; This is a spontaneous report from a contactable healthcare professional reporting for self. This 46-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL3247) on 14Jan2021 03:30 PM at single dose (vaccine location=Left arm) for COVID-19 immunisation. Medical history included known allergies: penicillin, erythromycin, seasonal allergies, can't really say food allergies but she had had reactions to random items on 2 occasions. Generally a very healthy person, no chronic health conditions. Patient was not pregnant. No other vaccine in four weeks. Did not have COVID prior vaccination. Concomitant medications in two weeks included lactobacillus acidophilus (FLORAJEN), vitamin D3. It was reported that on 14Jan2021 03:30 PM, within approximately 2 mins of getting the vaccination, she felt tingly, lightheaded and a little hot. That lasted a few minutes then started to subside. Also felt stiff in neck and a little aching in shoulder/chest area. Sat in observation for 20 mins to make sure she was ok. About 10 minutes after she left the facility (30 minutes after the shot), she felt the aching in upper left chest that turned into what felt like pulsing squeezes. She also got lightheaded again. Lasted several minutes. It was incredibly scary. Later that night and next 2 days she had felt the same achy/pulsing feeling periodically. No treatment received for events. The patient did not test COVID post vaccination. The outcome of events was unknown. No follow-up attempts are possible, No further information expected.
46 2021-01-29 palpitations A few hours after receiving vaccine, my heart started palpitating and would not stop. I have never e... Read more
A few hours after receiving vaccine, my heart started palpitating and would not stop. I have never experienced anything like this. I have NO previous medical problems and take no medications.
46 2021-01-30 chest discomfort Headache, fatigue, muscle pain, sore throat, sinus congestion, chest tightness (slight), dry co... Read more
Headache, fatigue, muscle pain, sore throat, sinus congestion, chest tightness (slight), dry cough. Headache started 1/25/21. Others started 1/26/21 and progressively got worse. Went to urgent care on 1/26. Missed work on 1/26 & 1/27.
46 2021-01-31 fast heart rate, hypertension, chest pain This is a spontaneous report from a contactable healthcare professional (patient). A 46-year- old fe... Read more
This is a spontaneous report from a contactable healthcare professional (patient). A 46-year- old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration in left arm on 16 Jan 2021 at 12:45 PM at a single dose for COVID-19 immunization in a hospital. Medical history included high cholesterol, GERD, Barrets esophagus, IBS-C, brain aneurysms, and known allergies to penicillin. The patient also received first dose of other vaccine in left (arm). Concomitant medications included clopidogrel bisulfate (PLAVIX), pravastatin, amitriptyline, famotidine, and ascorbic acid, ergocalciferol, nicotinamide, retinol, riboflavin, thiamine hydrochloride (VITAMINS). The patient has known allergies to Topamax. The patient experienced burning feeling from chest down to feet, tachycardia, high blood pressure, and chest pain on 16 Jan 2021 at 12:45 PM. The events resulted in emergency room/department or urgent care visit. The patient has no COVID prior to vaccination and was not tested for COVID post vaccination. The patient did not receive other vaccine in four weeks. No treatment received for the events. The patient is recovering from the events. Information on the batch/lot number has been requested.
46 2021-02-03 palpitations -Palpitations -Rash -Tingling of Hands and Feet
46 2021-02-03 palpitations Heart palpitations; This is a spontaneous report from a contactable consumer (patient herself). A 46... Read more
Heart palpitations; This is a spontaneous report from a contactable consumer (patient herself). A 46-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EL3247), via an unspecified route of administration (left arm), on 18Jan2021 10:30, at single dose, for covid-19 immunization. The patient has no medical history and has no known allergies. There were no concomitant medications. The patient experienced heart palpitations which began on 18Jan2021 the evening of taking the vaccine and have continued until now. Further reported that this adverse event started on 18Jan2021 10:00 AM. No treatment was received for the event reported. The patient was recovering from the event. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID prior vaccination and have not been COVID tested post vaccination.
46 2021-02-03 chest discomfort Lip and mouth numbness; hoarseness; chest pressure; lightheadedness; This is a spontaneous report fr... Read more
Lip and mouth numbness; hoarseness; chest pressure; lightheadedness; This is a spontaneous report from a contactable nurse. A 46-year-old nurse reported that she received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number unknown), at single dose in the Left arm on 15Jan2021 at 11:30 am for COVID-19 immunization.Medical history included allergy to latex. The patient's concomitant medications were not reported. On 15Jan2021 at 12:00 am the patient experienced lip and mouth numbness, hoarseness, chest pressure and lightheadedness. Since the vaccination, the patient has not been tested for COVID. No treatment was received. The outcome of the events was unknown. Information on the lot/batch number has been requested.
46 2021-02-03 fast heart rate, hypertension pain and numbness on left forearm near the injection site; pain and numbness on left forearm near th... Read more
pain and numbness on left forearm near the injection site; pain and numbness on left forearm near the injection site; mild hypertension; tachycardia; This is a spontaneous report from a contactable pharmacist. A 46-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL3249 and expiry date unknown) intramuscular at the left arm on 10Jan2021 at single dose for Covid-19 immunization in a hospital. Medical history was none. It was unknown if the patient was pregnant. The patient had no covid prior vaccination. The patient's concomitant medications were not reported. The patient had no other vaccine in four weeks. In Jan2021, the patient experienced pain and numbness on left forearm near the injection site, mild hypertension and tachycardia. The patient was not covid tested post vaccination. The patient did not receive treatment due to the events. The outcome of the events pain and numbness on left forearm near the injection site was recovered in Jan2021, while mild hypertension and tachycardia was unknown.
46 2021-02-04 blood pressure increased, heart rate increased Received the first dose on 12/16/2020, I tested positive for COVID on 12/28/2020. I received my sec... Read more
Received the first dose on 12/16/2020, I tested positive for COVID on 12/28/2020. I received my second dose on 1/7/2020, I was still having COVID symptoms. Symptoms worsened after the second dose. My heart rate has been out of control. I have been on steroids daily, because I was so short of breath. I have not been at work since being diagnosed with COVID. I went ahead and got the second dose, because my job told me that I had to get the second dose. I still have fatigue, elevated heart rate, blood pressure is till elevated. I have been started on blood pressure medication. I have also been diagnosed with severe sleep apnea. I had a sleep study performed. I am on two new inhalers. One is a steroid inhaler for lungs and one is a rescue inhaler for when I am short of breath. It has not pleasant. Headaches are horrible and daily. I went to ER, because headache was so severe. No medication I take for headaches work. I have not been able to work since I was diagnosed with COVID.
46 2021-02-04 pallor, chest discomfort Within a few minutes of vaccine, I got a severe piercing headache and nausea / vomiting which we att... Read more
Within a few minutes of vaccine, I got a severe piercing headache and nausea / vomiting which we attributed to nerves and I went to go home without reporting. During the drive the headache and nausea got worse and my extremities and face began to tingle. My chest felt tight. My body was shaking. My colleague noted weak pulses and pale complexion. I am a doctor and gave myself epinephrine 0.3 mg IM and within 60 to 90 seconds the symptoms improved dramatically. I had my husband pick me up at the office and went home. The headache and nausea worsened on the drive but then settled down significantly. I rested for a few hours, then took oral pred 20 mg at about 2:45. I noticed that my headache was back and very intense at about 3:15 pm. No nausea this time, but my left eye began itching and it was very tight / hard to breathe. My extremities began tingling and I had spasms / tremors of my muscles. I injected another 0.3 mg epi into my thigh and followed with dex sodium phosphate 4 mg IM. Symptoms resolved within about 2 to 3 minutes. I took 40mg more of oral pred. I also took 10 mg of pepcid PO. I am still feeling well now with no headaches or other symptoms at this writing (7:30 pm), but I have another doctor with me and we are 2 minutes from the ER if needed. I am marking unknown below since it has only been a few hours without symptoms.
46 2021-02-07 hypotension Feeling warm, dizzy, light-headed, hypotensive
46 2021-02-08 fast heart rate, palpitations, chest discomfort, blood pressure increased 7 mins after vaccine - flushing and palpitations. Then feeling of fullness in chest. Got taken to th... Read more
7 mins after vaccine - flushing and palpitations. Then feeling of fullness in chest. Got taken to the ER and had high bp 153/101 and tachy arrhythmia, such as trigeminy and bigeminy and heart rated in the 130?s. My ear also swelled and got hot and red on the same side as the shot. I was monitored for about three hours and then released after bp went down to 130?s/ 90?s and palps decreased.
46 2021-02-16 palpitations, chest pain I had severe palpitations that began 3 to 4 days after the vaccine. It felt like I was being stabb... Read more
I had severe palpitations that began 3 to 4 days after the vaccine. It felt like I was being stabbed in my chest with radiation into my neck. This lasted 2 to 3 weeks. I did go to the ED on 01/05/2021. I saw a cardiologist on 01/13/2021. I did get Dose 2 of the vaccine with the same symptoms but they were milder. I was put on an Event Monitor the week after Dose 2
46 2021-02-17 blood pressure increased tingling sensation in jaw and it extended to nose and it felt numb with difficulty swallowing; tingl... Read more
tingling sensation in jaw and it extended to nose and it felt numb with difficulty swallowing; tingling sensation in jaw and it extended to nose and it felt numb with difficulty swallowing; tingling sensation in jaw and it extended to nose and it felt numb with difficulty swallowing; raised blood pressure; metallic taste; This is a spontaneous report from a contactable healthcare professional. A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number 0041297301), via an unspecified route of administration in left arm on 15Jan2021, at 17:00 as first single dose for covid-19 immunisation. Medical history included obesity, opiate allergy and artichokes allergy from an unknown date. Concomitant medication included unspecified probiotic, levothyroxine (MANUFACTURER UNKNOWN), ascorbic acid (VIT C), ergocalciferol (VIT D), linum usitatissimum seed oil (FLAXSEED OIL NATURE MADE). The patient experienced the following non-serious events: metallic taste on 15Jan2021, at 17:30 with outcome of recovered in Jan2021; tingling sensation in jaw and it extended to nose and it felt numb with difficulty swallowing on 15Jan2021, at 17:30 with outcome of recovered in Jan2021; raised blood pressure on 15Jan2021, at 17:30 with outcome of recovered in Jan2021. Details were as follows: following vaccination the patient reported a metallic taste in her mouth, then a tingling sensation in her jaw which extended to her nose and it felt numb with difficulty swallowing, and she also had raised blood pressure. No treatment was received for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19, and since the vaccination, the patient has not been tested for COVID-19.
46 2021-02-18 blood pressure increased Tongue swelling; difficulty swallowing; raised blood pressure; body weakness; redness; This is a spo... Read more
Tongue swelling; difficulty swallowing; raised blood pressure; body weakness; redness; This is a spontaneous report received from a contactable consumer (patient). A 46-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: not available), via an unspecified route of administration on left arm on 01Feb2021 16:00 at single dose for COVID-19 immunization. Age at vaccination was 46 years. The patient was not pregnant at the time of vaccination. Medical history included food irritations. Concomitant medications included unspecified vitamins (received within 2 weeks of vaccination). The patient didn't received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19, Prior to vaccination. The patient has not been tested for COVID-19, since the vaccination. The patient experienced tongue swelling, difficulty swallowing, raised blood pressure, redness, body weakness on 01Feb2021 at 16:30. The events resulted in emergency room visit/ department or urgent care visit. The patient received breathing treatments and unspecified IV medication for the events. The events were assessed as non-serious by the reporter. The outcome of the events was reported as unknown. Information on the lot/batch number has been requested.
46 2021-02-19 cerebrovascular accident 24-48 hours after receiving dose, had low grade fever, headache, and malaise. On Tuesday morning (3 ... Read more
24-48 hours after receiving dose, had low grade fever, headache, and malaise. On Tuesday morning (3 days after vaccine), woke up with vertigo, visual changes, severe nausea, diagnosed with cerebrovascular accident
46 2021-02-21 pulmonary embolism Patient was admitted s/p hysterectomy, found to have PE and AKI. Patient treated with heparin drip, ... Read more
Patient was admitted s/p hysterectomy, found to have PE and AKI. Patient treated with heparin drip, transitioned to Eliquis and discharged
46 2021-02-22 blood pressure increased C/o right am numbness from injection site down back of arm. Full ROM of R. arm. Felt dizzy, slight... Read more
C/o right am numbness from injection site down back of arm. Full ROM of R. arm. Felt dizzy, slight redness below injection site. BP taken was elevated, sent to ED for additional monitoring
46 2021-02-22 chest discomfort Heaviness in chest. Swelling on face , eyes and lips
46 2021-02-23 blood pressure increased, chest pain patient began feeling tingling sensation at injection site left arm. A few minutes later dizziness ... Read more
patient began feeling tingling sensation at injection site left arm. A few minutes later dizziness and (now stating shortness of breath) original evaluation, assessment and patient statements did not reveal shortness of breath. She was speaking softly, SaO2 was 98. Provided gatoraid and offered weather. Husband stated she had previous similar reaction post-anesthesia. at 1515. Patient began to feel weakness over entire body. Refused ambulance at that time. 1520- began having chest pain, tingling in legs and feet. Husband said he would take her to the ER due to BP continuing to be elevated. 1528- Unable to stand requesting an ambulance. a1530- EMS called at 1535 ambulance confirmed. 1540- Ambulance arrived. Turned over care to EMS
46 2021-02-28 heart rate increased Increased heart rate. Over 100 when resting; This is a spontaneous report from a contactable consume... Read more
Increased heart rate. Over 100 when resting; This is a spontaneous report from a contactable consumer (the patient). A non-pregnant 46-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: El9261) via an unspecified route of administration, on the left arm, on 22Jan2021 at 15:30 PM (at the age of 46 years) at a single dose for COVID-19 immunization. Medical history included Hashimoto's disease. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication taken within two weeks of vaccination included liothyronine (LIOTHYRONINE), thyroid (ARMOUR THYROID). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 22Jan2021 at 16:30 PM, the patient experienced increased heart rate, over 100 when resting. The event was reported as non-serious. The patient had lab tests which included heart rate: over 100 on 22Jan2021. No treatment was given. The clinical outcome of the increased heart rate, over 100 when resting was recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
46 2021-03-02 chest pain, chest discomfort Chest burning and tightness and SOB. Gave albuterol neb and Benadryl.
46 2021-03-03 chest discomfort Patient received her first dose of the Pfizer vaccine today. She had developed chest tightness and ... Read more
Patient received her first dose of the Pfizer vaccine today. She had developed chest tightness and wheezing yesterday, she has a history of asthma. The chest tightness and wheezing increased after her vaccine. She also noted tingling to her lips and dizziness. She had no shortness of breath, cough, palpitations or chest pain. No angioedema, rash or pruritis. She was in no acute distress. She was talking in complete sentences and drinking water without any issues. Her lungs were clear through out with no bronchospasm, her heart rate was regular. BP 160/100, HR 66, RR 22, O2 99% on room air. I spoke with the RN at ICC who accepted patient to be seen at the ICC for further evaluation and monitoring. Patient declined ambulance transfer and felt comfortable enough to drive her self to the ICC. She was monitored at the vaccine clinic for 35 minutes after receiving her vaccine and left in stable condition. Her sister was notified.
46 2021-03-04 palpitations, chest discomfort Clammy hands, warm wave rushed over my body, felt very hot, racing heart, tightness in my chest-last... Read more
Clammy hands, warm wave rushed over my body, felt very hot, racing heart, tightness in my chest-lasted approx 15-20 minutes
46 2021-03-09 fibrin d dimer increased, pulmonary embolism, deep vein blood clot, chest pain, chest discomfort got vaccine - about a week later - she sent us a message saying "I have been having right calf pain ... Read more
got vaccine - about a week later - she sent us a message saying "I have been having right calf pain for about a week or more. I have more increased SOB and chest pain." was able to get ddimer which was elevated - and was admitted to the hospital for this since her vaccine - she has noticed increased chest tightness, SOB, hairloss, DVT/PE.
46 2021-03-18 palpitations, hypertension, fast heart rate In the first 5 mins after the injection I became very irritable and then within 10 mins had a cold s... Read more
In the first 5 mins after the injection I became very irritable and then within 10 mins had a cold sensation in my head that I had previously had after a reaction to sulfa and had almost passed out. I told a staff person who had me talk to one of the nurses & put me in a separate space from people getting vaccinated. The nurses then wasted a lot of time talking to me about anxiety instead of treating me. The cold sensation traveled from my head down my neck, there was a sharp pain in my left breast, and then my heart started racing. My lips and tongue on the left side started swelling. I told the nurses this but they ignored me. Eventually they brought in equipment to monitor my vital signs. My blood pressure and heart rate were higher than I had ever seen them and kept rising. The head nurse eventually said I needed medical care & there was no doctor on site. She called the paramedics. It was now 1 hour after I told them something was wrong. The paramedics thought this was temporary because my bp fell to 153 [I told them I did not have a hist of bp this high] from where it had been before & gave me Benadryl pills. (The ER doctor later said they should have done something). Later that night my HR went up to 220 and I was taken to the ER. The ER doctor also wasted time assuming it was anxiety but bloodwork showed I was in shock. They first treated me with 4 aspirin, then Atavan, which all did nothing. My bp was up to 189 the last time I could view the monitor. Sodium chloride ivs, Bendaryl ivs were given after the bloodwork. Diltiazem was eventually also given. I had palpitations that caused my entire body to shake. EKG showed I had developed an atrial flutter and the doctor said the flutter, arrhythmia, and tachycardia were caused by the shock from the vaccine disrupting the electrical signals in my heart. I stayed overnight in the ER until Sat morning. I took Diltiazem but jolting palpitations and tremors did not stop. I saw a cardiologist on the 25th who concluded I had gone into shock from the vaccine, and I was given the wrong medication, and put me on metropolol. Metoprolol lowered my bp and reduced the palpations. I weaned off it with the doctor's permission. I still have palpitations.
46 2021-03-18 fainting Vomiting fainting took a nop as the day went on the pain on my R leg got worse; Vomiting fainting to... Read more
Vomiting fainting took a nop as the day went on the pain on my R leg got worse; Vomiting fainting took a nop as the day went on the pain on my R leg got worse; vomiting fainting took a nop as the day went on the pain on my R leg got worse; Symptoms of fatigue; Pain on my R knee; Went to fever 102.2 then; Chills, into the entire night/Shivers and shakes; Headache; Into the morning could not walk on my R leg/Can not walk on either foot; Numbness to my face; Found a cyst on the back of my knee; Shivers and shakes; Damage to my ligaments; This is a spontaneous report from a contactable other HCP (patient). A 46-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via intramuscular in the left arm on 04Feb2021 at single dose for covid-19 immunisation. The patient was not pregnant. The patient medical history was none, and concomitant medications were not reported. The patient was not sure about allergies. The Patient not received other vaccine in four weeks. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3249), via intramuscular Left arm on 14Jan2021 04:30 PM at single dose for COVID-19 immunization (at the age of 46-years). The patient stated, "on 12Feb2021 at 03:30 PM, (as reported: one week after the second dose) after the second dose of vaccination. I started having symptoms of fatigue, pain on my R knee, went to fever 102.2 then, chills, into the entire night, headache, into the morning could not walk on my R leg, numbness to my face, vomiting fainting took a nop as the day went on the pain on my R leg got worse. Went to the ER (emergency room) x ray and ultrasound was done, found a cyst on the back of my knee not sure if it was from the shivers and shakes caused damage to my ligaments, 2 hours later my right foot was in a lot of pain, two bumps onto of my L foot lots of pain went back to the ER on Sunday morning (14Feb2021), x ray was done only no broken bones foot was red turned purplish, this started Friday 12th (12Feb2021) and her Monday the 16th Tuesday missed work and still in a lot of pain cannot walk on either foot very far without my boot or crushes." No covid prior vaccination. The patient underwent lab tests and procedures which included post vaccination sars-cov-2 test Nasal Swab: negative on 23Dec2020; body temperature: 102.2 on an unknown date; ultrasound scan and X-ray: cyst on the back of my knee on 12Feb2021, x-ray: no broken bones foot on 14Feb2021. Took the following treatment measures, shot for pain, cortisone shot, naproxen 500. The adverse events resulted in doctor or other healthcare professional office/clinic visit/Emergency room/department or urgent care. The outcome of the events was not recovered. Information on the lot/batch number has been requested.; Sender's Comments: Based on the temporal relation, the association between the event syncope and the vaccination with BNT162B2 cannot be completely ruled out. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
46 2021-03-21 excessive bleeding, low platelet count, blood clot, blood pressure decreased severe thrombocytopenia; Bleeding at Impella insertion site; peripheral swelling in hands/feet; card... Read more
severe thrombocytopenia; Bleeding at Impella insertion site; peripheral swelling in hands/feet; cardiogenic shock; myocarditis; hypoxic respiratory failure; mural thrombus; hypotensive despite pressors; fever; cough; myalgias; This is a spontaneous report from a contactable physician. A 46-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and Expiration date was not provided), intramuscularly on 05Feb2021 as a single dose for COVID-19 immunisation. The patient's medical history included hyperlipidemia and COVID-19 pneumonia from an unspecified date in Jan2021 to an unspecified date in Jan2021 (the patient was diagnosed with COVID-19 pneumonia prior to the vaccination. Recovered. Returned to work on 25Jan2021). Concomitant medications included atorvastatin orally at 10 mg, once a day, acetylsalicylic acid (ASPIRIN) orally at 81 mg, once a day, colecalciferol (VITAMIN D); all the drugs were received within two weeks. The patient previously took clindamycin and experienced known allergies: Clindamycin. The patient did not receive other vaccine in four weeks. The patient developed fever, cough, myalgias on 19Feb2021 at 12:00 AM. She developed peripheral swelling in hands/feet on 24Feb2021, she was evaluated in the ER; admitted to (hospital name withheld) on 24Feb2021 with cardiogenic shock, myocarditis, hypoxic respiratory failure. The patient was started on IV vancomycin and Unasyn. TTE (transthoracic echocardiogram) demonstrated LVEF (left ventricular ejection fraction) 35%; reduced biventricular function; mural thrombus on 24Feb2021. Remained hypotensive despite pressors on 24Feb2021. Patient had elevated PCW with preserved cardiac index. Patient underwent VA ECMO (veno-arterial extracorporeal membrane oxygenation) and Impella placement on 25Feb2021. COVID-19 PCR was negative. Blood cultures were no growth. She developed severe thrombocytopenia and developed bleeding at Impella insertion site on 25Feb2021; required multiple, PRBC transfusions. Evaluated for HLH; Soluble IL2 receptor on 26Feb2021 elevated at 7232 pg/mL; ferritin 3054; CRP > 300. ECMO stopped 03Mar2021. The patient was treated with IV antibiotics, mechanical ventilation, pressor support, underwent VA ECMO and Impella placement. The patient was hospitalized from 24Feb2021 to 16Mar2021. Number of days of hospitalization was 20 days. The patient tested COVID post vaccination. The patient underwent lab tests and procedures which included blood pressure: hypotensive despite pressors, LVEF: 35 %, nasal swab: Negative on 24Feb2021, blood cultures: No growth, nasal swab: Negative on 25Feb2021, ferritin: 3054, HLH: Evaluated, Soluble IL2 receptor: 7232 pg/mL (elevated at 7232 pg/mL), CRP: > 300 on 26Feb2021, nasal swab: Negative on 11Mar2021, nasal swab: Negative on 14Mar2021. The events were considered as serious (hospitalization and life threatening) by the physician. The outcome of the events was recovering. Information about lot/batch number has been requested.; Sender's Comments: the events being serious, life threatening and hospitalisation ,medical intervention required are assessed as possibly related to the suspect drug __BNT162B2____ based on strong temporal association, but consider also possible contributory effects from patient's medical history and/or concomitant medications.
46 2021-03-24 pulmonary embolism Shortness of breath, Diffuse Pulmonary Embolism with Ground glass opacities, happened over course of... Read more
Shortness of breath, Diffuse Pulmonary Embolism with Ground glass opacities, happened over course of 1 week
46 2021-03-24 heart rate increased Tingling sensation in tongue within 2 minutes of injection, swelling of tongue to twice the thicknes... Read more
Tingling sensation in tongue within 2 minutes of injection, swelling of tongue to twice the thickness, itchy mouth, and rapid heartrate within 10 minutes, redness, burning, swelling, and itchy skin on face within 15 minutes. Epi-pen given within 14 minutes, and transport to hospital, wheezing in bases of lungs noted by ER physician and diphenhydramine, famotidine, and solumedrol given. Swelling of tongue took 1.5 hours to reduce to half. Overnight stay at hospital, due to severity and duration of symptoms.
46 2021-03-24 blood pressure increased, fast heart rate congestion and wheezing in left upper lobe of lung; congestion and wheezing in left upper lobe of lu... Read more
congestion and wheezing in left upper lobe of lung; congestion and wheezing in left upper lobe of lung; short of breath; left side of my face became numb; tachycardic; Blood Pressure 162/110; chills; burning in my mouth; tingling throughout body; dizziness; fog brain/Memory loss/felt as if out of body experience" or just not normal for about 12 to 14 days; fog brain/Memory loss; muscle pain; bruising not at site (in legs); lymph node swelling on injection arm sight; I finally felt pain at injection site; This is a spontaneous report from a contactable health care professional nurse, the patient. A 46-years-old non-pregnant female patient (nurse) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EH9899); intramuscular on 20DEC2020 at 22:30 (at the age of 46 years old) as a single dose, for COVID-19 immunization. Medical history included hypothyroid, Allergic to Latex. The patient previously took levonorgestrel and experienced drug hypersensitivity. The patient's concomitant medications were not reported. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 20Dec2020 The patient experienced congestion and wheezing in left upper lobe of lung, short of breath, left side of my face became numb, tachycardic, Blood Pressure 162/110, chills, burning in my mouth, tingling throughout body, dizziness, brain/memory loss/felt as if out of body experience" or just not normal for about 12 to 14 days, muscle pain, bruising not at site (in legs), lymph node swelling on injection arm sight and on about the 5th day Dec2020 experienced pain at injection site. The patient underwent lab tests and procedures which included blood pressure: 162/110 on an unspecified date and heart rate tachycardic on an unspecified date. The clinical course is as follows Shortly right at 15 minute mark of being monitored, I became short of breath, left side of my face became numb, then right, became tachycardic, Blood Pressure 162/110, developed chills, burning in my mouth, tingling throughout body, dizziness, developed "fog brain"/Memory loss prevalent for following 48 hours after injection, remained not as severe about a week after, muscle pain, bruising not at site (in legs) developed lymph node swelling on injection arm sight, developed congestion and wheezing in left upper lobe of lung. "felt as if out of body experience" or just not normal for about 12 to 14 days. Patent Refuse to go to ER, where advised to go after RAD team assessed, around the 5th day I finally felt pain at injection site-which that part would be normal, but I did not feel at 1st due to all the major reactions my body dealt with. As a result of the events the patient did visit a physician. Treatment was given for the events (Pulmonary congestion, wheezing, dyspnea, hypoesthesia, tachycardia, chills burning sensation, paranesthesia, dizziness, feeling abnormal, Amnesia, Myalgia, Contusion, Lymphadenopathy, Vaccination site pain) which included Benadryl, Tylenol, IBU, and steroids, Cold and cough meds OTC. The clinical outcome of the events Pulmonary congestion, wheezing, dyspnea, hypoesthesia, tachycardia, chills burning sensation, paranesthesia, dizziness, feeling abnormal, Amnesia, Myalgia, Contusion, Lymphadenopathy, and Vaccination site pain was recovering while blood pressure 162/110 was unknown.
46 2021-03-25 heart attack, heart attack Vaccine administered 12/31/20. SCAD heart attack on 01/21/21.
46 2021-03-28 hypertension, loss of consciousness The second day after injection temperature dropped to 93.7; I was very cold; I was dizzy almost pass... Read more
The second day after injection temperature dropped to 93.7; I was very cold; I was dizzy almost passed out; tired; nausea; headache; almost passed out; Hypertension/BP 155/103; This is a spontaneous report from a contactable consumer (patient). A 46-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EN6203, expiry date not reported) via an unspecified route of administration, administered in left arm on 04Mar2021 at a single dose for COVID-19 immunisation. Medical history included interstitial cystitis and endometriosis, known allergies to milk and sulfa, have had a complete hysterectomy, and patient was getting hormone injections. The patient was not pregnant at the time of the report and vaccination. The patient had no covid prior to vaccination. Concomitant medications were unspecified; it was reported that patient had other medications in two weeks. The patient previously took ibuprofen and experienced known allergies; and had first dose of bnt162b2 for covid-19 immunisation on an unknown date. The patient had no other vaccine in four weeks. The second day after injection (06Mar2021), temperature dropped to 93.7, BP 155/103, and patient was very cold. Patient was dizzy, almost passed out (Mar2021). Patient temp ran from 97 to 98 and was able to get temp up to 95 (2021) but it's been there and dropping to 94.9 since 06Mar2021. Patient did have hypertension BP but take meds for it (Mar2021). Patient was also very tired, nausea and headache on and off (Mar2021). But all those have been reported. It's not normal for the patient to be cold because patient have had a complete hysterectomy and was getting hormone injections. Therapeutic measures were taken as a result of the event hypertension. No treatment received for the other events reported. The patient was not tested for covid post vaccination. The outcome of the events was not recovered.
46 2021-03-30 fainting felt very faint and weak; chills/shivers; cold sweating; felt very faint and weak; extreme lethargy;... Read more
felt very faint and weak; chills/shivers; cold sweating; felt very faint and weak; extreme lethargy; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, in Arm Left on 17Mar2021 10:45 (Lot Number: EL3247) as SINGLE DOSE for COVID-19 immunization. Medical history and concomitant medication was reported as none. The patient previously had BNT162B2 first dose lot number: EL3247 on 24Feb2021 10:00 AM, in left arm for COVID-19 immunization. The patient was not pregnant at time of vaccination. The facility where the most recent COVID-19 vaccine was administered was in the clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 17Mar2021 20:30, the patient experienced chills, shivers, cold sweating, felt very faint and weak and extreme lethargy. No treatment was given to the patient for the events. The outcome of the events was recovered on unspecified date.
46 2021-04-03 chest pain, nosebleed She presented to the ER on 2/13 with a lot of chest pain and had some flattening of her T waves. S... Read more
She presented to the ER on 2/13 with a lot of chest pain and had some flattening of her T waves. She ended up getting a cardiac catheterization while she was there which was normal. The day prior to this she had actually received her second Covid vaccination in her left arm. She noticed achiness and soreness across her shoulders bilaterally into her chest and into her neck. She had some subjective fevers and chills and felt generally fatigued. She also had a lot of swelling in her left axilla and she ended up getting a CT scan during her workup which revealed some left axillary adenopathy. She returned to the ER on 3/16: while brushing her teeth, she developed right facial paresthesias that marched over approximately 20 minutes to involve the right arm and the right leg. She went to the hospital. She was seen in the ER. They felt this represented possible ischemia. They gave her tPA. She had a hemorrhagic nosebleed. Did not develop any other signs of bleeding. Her symptoms had not resolved. She was discharged from home. She had a headache at the time of her visit to the ER. Her headache had resolved by the time she was discharged home, but she continues to note paresthesias in the right side of her body, right face, and notes over the last day or 2, she has had increased dysarthria, dizziness and slurred speech, brain fog, a sensation of heaviness and inability to think. She states she currently does not have head pain per se, but she does note that she just feels generally poorly. She feels like her brain is working faster than her mouth muscles are. She is in today for neurologic followup, concerned about these ongoing issues. she continues to struggle with her speech feeling quite slow and deliberate, she feels like it is difficult for her to concentrate, she is forgetful, she still has intermittent episodes of paresthesias in her face, arm, and hand, she feels like she becomes heart and flushed and she has some heart rate variability with her heart going slow and fast, and she has significant disequilibrium. She is extremely fatigued where she is only able to get up for 1-2 hours before she is extremely fatigued and has to go back to bed.
46 2021-04-05 low platelet count Thrombocytopenia Now 2 aneurism in brain Angio scheduled for 4/14/21
46 2021-04-06 fainting, loss of consciousness patient fainted as lost consciousness; patient fainted as lost consciousness; patient urinated in he... Read more
patient fainted as lost consciousness; patient fainted as lost consciousness; patient urinated in her pants; Felt dizzy after 12 hours; patient had problems with concentrating; massive headache; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 09Mar2021 09:30 (lot number: 1; pending clarification) at the age of 46 years old, as single dose for covid-19 immunization. Medical history included allergy to metals (titanium metal). Concomitant medications were none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications received within 2 weeks of vaccination. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. On 09Mar2021 21:00, the patient experienced massive headache. After 12 hours (09Mar2021 21:30), the patient felt dizzy. On 10Mar2021, around 10 am, the patient fainted as lost consciousness, urinated in her pants and had problems with concentrating. No treatment was given for the adverse events. Since vaccination, the patient has not been tested for COVID-19. The patient was recovering from all the events.
46 2021-04-07 hypertension atient felt subjective swelling and parasthesias in her tongue within first 30 minutes and eventuall... Read more
atient felt subjective swelling and parasthesias in her tongue within first 30 minutes and eventually sensation of swelling in her throat within 60 minutes. There were no other secondary systemic/organs affected apart from mild transient hypertension. Given the strong concern for subjective airway compromise, I directed the administration of epi which the patient said she felt her throat relax after adminstration. 911 was called and patient was transported to ED.
46 2021-04-08 pulmonary embolism I was diagnosed with a pulmonary embolism on 1/15/21
46 2021-04-10 chest pain 7 days after the second Covid vaccine shot, painful burning feet woke me up in the middle of the nig... Read more
7 days after the second Covid vaccine shot, painful burning feet woke me up in the middle of the night, it wouldn?t go away,, with pins and needles itching all day. Then again the following night (last night) my feet burned all night. In hindsight, I had had a very bad reaction after the second shot on 4/2 that started the night of the shot, when I woke up at 3 am feeling like my feet, legs and entire body was burning, then Saturday I had a high fever all day, 103.8, chills, burning sensation on and off, chest pain, heart pain, which I treated first with Tylenol then Motrin. It was a horrible two nights, but by Sunday 4/4 I was fine. I have been fatigued all week but didn?t think much about it. Then Friday night into Saturday of exactly a week after the second shot, this has happened. The burning sensation on my feet is intolerable and I haven?t slept for two nights.
46 2021-04-12 deep vein blood clot DVT right leg began on evening of Feb 28 but became evident March 1 morning and diagnosed evening at... Read more
DVT right leg began on evening of Feb 28 but became evident March 1 morning and diagnosed evening at ER
46 2021-04-12 fast heart rate, fibrin d dimer increased, pulmonary embolism, troponin increased, chest pain Massive PE, patient died. No history of DVT, we did a COVID test here and it was negative. She had ... Read more
Massive PE, patient died. No history of DVT, we did a COVID test here and it was negative. She had no PMH, we suspect the vaccine made her hypercoagulable. Had pleuritic CP, tachycardia, tachypnea.
46 2021-04-12 pulmonary embolism Went to ER and was diagnosed with bilateral pulmonary emboli; Pain on left lung/torso/Severe pain on... Read more
Went to ER and was diagnosed with bilateral pulmonary emboli; Pain on left lung/torso/Severe pain on Left lung/torso, pain starting at collar bone down the torso; increased difficulty breathing; Vomiting; fever 99.2/fever 99.6; Tired; Nausea; This is a spontaneous report from a contactable consumer. A 46-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ER 8727), via an unspecified route of administration, at the age of 46 years, administered on the left arm on 23Mar2021 10:45 at a SINGLE DOSE for covid-19 immunisation. Medical history included drug hypersensitivity to PCN from an unknown date and unknown if ongoing. Concomitant medications included ethinylestradiol, norgestimate (TRI-SPRINTEC) and fluoxetine (FLUOXETINE); both taken for an unspecified indication, start and stop date were not reported. The patient previously took amoxicilin and experienced drug hypersensitivity. The patient went to ER and was diagnosed with bilateral pulmonary emboli on 23Mar2021 21:30, pain on left lung/torso/severe pain on left lung/torso, pain starting at collar bone down the torso on 23Mar2021 21:30, increased difficulty breathing on 23Mar2021 21:30, nausea, vomiting, fever 99.2/ 99.6, tired on 23Mar2021 21:30. The patient underwent lab tests and procedures which included body temperature: 99.2 on Mar2021, body temperature: 99.6 on Mar2021, sars-cov-2 test: negative on 01Apr2021. Therapeutic measures (Eliquis (blood thinners)) were taken as a result of the events. The events were reported as Life threatening. The outcome of the events was recovering.
46 2021-04-12 heart rate increased overwhelming since of hotness; Dizziness; broke out in a rash everywhere; heart rate went up; This i... Read more
overwhelming since of hotness; Dizziness; broke out in a rash everywhere; heart rate went up; This is a spontaneous report from a contactable Nurse. This female Nurse reported for herself that a 46-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot no: EP7534, Expire Date: 31Jul2021), 0.3ml intramuscular injection in left deltoid as a single dose for covid 19 immunisation on 26Mar2021 at 1:00PM. The patient medical history included blood pressure, migraine. The patient concomitant medication included Amitriptyline 100mg once a day for Blood pressure, Amlodipine Besilate at 5mg every day for Migraine, Sumatriptan (Sumatriptan)100mg as needed for Migraine. The patient received the first dose of Pfizer COVID19 vaccine on 26Mar2021 and had an immediate reaction. She needed 50mg of Benadryl, within 15 seconds of the vaccine. she had an overwhelming since of hotness and did not last very long, maybe 3 seconds and It washed over her. The feeling like she was going to pass out came after the overwhelming since of hotness. They put her feet up and put on nasal cannula with 2L of oxygen. The feeling like she was going to pass out came and went with the dizziness. She was dizzy on and off for 30 minutes. The rash started immediately, and It went away about 5 o'clock that evening and the Heart rate went up: it was 122 beats per minutes on 26Mar2021. It came down back to normal within an hour. All the events were assessed as medically significant. The outcome of felt like she was going to pass out, overwhelming since of hotness, Dizziness, broke out in a rash and heart rate went up was recovered on 26Mar2021. Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the available information and close temporal association, a possible causal relationship cannot be excluded between the suspect product BNT162B2 and all reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
46 2021-04-12 hypertension skin hurting like a neuropathy; chills; she experienced a rash; My blood pressure was high; anaphyla... Read more
skin hurting like a neuropathy; chills; she experienced a rash; My blood pressure was high; anaphylactic reaction; my throat was closing; my tongue swelled up to the back of my throat; she experienced Body aches; At home she started wheezing; Dry cough; Hoarse voice; Upper airway swelling; Difficulty breathing (without wheeze or stridor); bronchospasm; Respiratory distress; This is a spontaneous report from a contactable other hcp (patient). A 46-years-old (non-pregnant) female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: ER8732), dose 1 via an unspecified route of administration, administered in Arm Left on 26Mar2021 at 10:30 as single dose for COVID-19 immunisation. Medical history included celiac disease and asthma. The patient had allergies to medications, food, or other products. Concomitant medication(s) (received within 2 weeks of vaccination) included levocetirizine dihydrochloride (XYZAL), Dexalant and birth control pill. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the was not patient diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 26 Mar2021, the patient experienced anaphylactic reaction, my tongue swelled up to the back of my throat, my blood pressure was high, my throat was closing, she experienced body aches and at home she started wheezing/bilateral wheeze. Within minutes of receiving the vaccine, my tongue swelled up to the back of my throat and she had a weird sensation in her throat, 15 minutes later she was not able to form words. The patient was given liquid Benadryl (oral) for my tongue swelled up to the back of my throat and her symptoms resolved. She went to the nurse station, who took her BP which was high, which it normally is not so the treating physician felt confident in letting me go home. She was monitored for an hour and was sent home with no more tongue swelling. At home she started wheezing. She called her HCP and was advised to take a nebulizer with no effect. At around 14:00, when the Benadryl wore off, her throat was closing so she was directed to epi-pen herself and call 911. She was taken by ambulance to the hospital and treated for anaphylactic reaction to the vaccine. She was given prednisone 50mg by mouth daily for four days and a refill for her Epipen. No additional Epipen was administered. On 29Mar2021, the patient experienced skin hurting like a neuropathy, chills and she experienced a rash. On an unknown date in Mar2021, she experienced bronchospasm, upper airway swelling, respiratory distress, dry cough, hoarse voice and difficulty breathing (without wheeze or stridor). No sneezing or rhinorrhea. She was treated with adrenaline, corticosteroids, antihistamine, IV fluids, Oxygen, bronchodilators and other. The adverse event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The administering doctor not to take the second vaccine. The outcome of the events anaphylactic reaction, my tongue swelled up to the back of my throat, my blood pressure was high and my throat was closing was recovered with sequealae, skin hurting like a neuropathy, she experienced body aches, at home she started wheezing/bilateral wheeze, chills and she experienced a rash was recovered and bronchospasm, upper airway swelling, respiratory distress, dry cough, hoarse voice and difficulty breathing (without wheeze or stridor) was unknown. Follow up attempts are needed. Information on lot /batch number was obtained.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of reported events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
46 2021-04-13 chest pain, palpitations, hypertension, heart rate increased High heart rate (140-150) while sitting. High Blood Pressure (150/90) while sitting. Left side chest... Read more
High heart rate (140-150) while sitting. High Blood Pressure (150/90) while sitting. Left side chest pain. Heart palpitations. Welt at injection site, was painful and itchy. Stomach cramping and loose stool.
46 2021-04-13 atrial fibrillation, cardiac arrest a fib and cardiac arrest
46 2021-04-13 chest pain, pulmonary embolism patient developed chest pain, right rib pain and dyspnea 1 day following vaccine
46 2021-04-15 loss of consciousness Pt c/o of light headedness while in observation. Pt had slurred speech, skin was cold and clammy, an... Read more
Pt c/o of light headedness while in observation. Pt had slurred speech, skin was cold and clammy, and pt had intermittent loss of consciousness. Maintained pt in a comfortable position until EMS arrived. BP 193/130, HR 124, O2 99%, RR 14.
46 2021-04-20 chest discomfort Fever, fatigue, body aches, loss of taste, loss of appetite burning at injection site immediately an... Read more
Fever, fatigue, body aches, loss of taste, loss of appetite burning at injection site immediately and hotness around site for three days, heaviness in chest all the way through to back, shortness of breath
46 2021-04-20 loss of consciousness passed out and went completely unconscious; Nauseous; felt weak like someone sucked all her energy o... Read more
passed out and went completely unconscious; Nauseous; felt weak like someone sucked all her energy out; in between going unconscious and coming to, she threw up and peed on herself and had shaking and chills; in between going unconscious and coming to, she threw up and peed on herself and had shaking and chills; in between going unconscious and coming to, she threw up and peed on herself and had shaking and chills; in between going unconscious and coming to, she threw up and peed on herself and had shaking and chills; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration at the age of 46-years-old, administered in Arm Left on 01Apr2021 13:30 (Lot Number: ER8734) as single dose for COVID-19 immunization. Medical history included ongoing High Blood Pressure, hyperthyroidism from 28Mar2021 and ongoing, allergy to Cheese and penicillin. Everyone in her family has done fine with the vaccine except her. Concomitant medications included thiamazole (METHIMAZOLE) taken for hyperthyroidism from 28Mar2021 and ongoing; atenolol, chlortalidone (ATENOLOL AND CHLORTHALIDONE) taken for hypertension from an unspecified start date and ongoing; amlodipine (AMLODIPINE) taken for hypertension from an unspecified start date and ongoing. On Thursday 01Apr2021, the patient had her first shot and she stayed for 30 minutes. After she was allowed to leave, she passed out and went completely unconscious and she was rushed to the ER. She sat for the 30 minutes, then got to her car and it took 10 minutes to get to department store and with in 7 minutes of being at department store she started feeling nauseous then came the fatigue and she felt nauseous and felt like she was going to pass out so she sat down, she didn't know what was going on. It started with her feeling nauseous and then she started to feel weak like someone sucked all her energy out. She states in between going unconscious and coming to, she threw up and peed on herself and had shaking and chills. The EMS took her to the ER. The adverse events occurred on 01Apr2021 14:30 (as reported). The ER let her go home Thursday night. They gave her an IV and did lab work and the lab work came back fine. It was a combination of her meds and the vaccine or it was just the vaccine. Her primary doctor said it was the vaccine. She is scheduled 22Apr2021 for her second one and she is calling to see if there is any advice or anything she needed to do for the second shot. Her doctor told her that when she takes it, she needs to be close to the ER so a doctor can monitor her. Treatment for events included IV fluids to help from being dehydrated and throwing up, Emergency Room, possibly Benadryl. The events required a visit to Emergency Room on 01Apr2021 and to the Physician Office on 05Apr2021. The outcome of the events passed out and went completely unconscious and felt weak like someone sucked all her energy out was recovered on 02Apr2021 while for the rest of the events was recovered on 01Apr2021. The events were considered as serious (medically significant). No Prior Vaccinations (within 4 weeks), no adverse events following prior vaccinations. Information on Lot/Batch number was available. Additional information has been requested.
46 2021-04-24 fainting, heart rate increased, hypertension fainted/fainting; felt weak and dizzy/weakness; felt weak and dizzy/dizziness; blood pressure was ve... Read more
fainted/fainting; felt weak and dizzy/weakness; felt weak and dizzy/dizziness; blood pressure was very high; fast heartbeat; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a 46-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8733), via an unspecified route of administration, administered in arm left on 27Mar2021 18:15 (at the age of 46-years-old) as a single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. The patient had no covid prior vaccination. No other medication in two weeks. No other vaccine in four weeks. On 27Mar2021 18:45, the patient felt weak and dizzy a few minutes after getting the vaccine and then she fainted. The paramedics took her to the ambulance to check her vitals. EKG, blood sugar and blood oxygen was good, but her blood pressure was very high. Clinical course details was reported as she received the first dose of the Pfizer COVID vaccine on 27Mar2021 and she experienced fainting, dizziness, weakness and a fast heartbeat. The patient would like to know if fainting was considered an allergic reaction. The patient would like to know if she should receive the second dose of the vaccine. She received the 1st dose last 27Mar2021 and 2nd dose will be on 17Apr2021. The reported events resulted in doctor or other healthcare professional office/clinic visit. The patient did not received any treatment for the events. The outcome of the events was recovering. The patient did not covid tested post vaccination.
46 2021-04-26 deep vein blood clot, blood clot Approximately 2 weeks after the vaccine, inexperienced deep leg pain. 3 days later I went to the ho... Read more
Approximately 2 weeks after the vaccine, inexperienced deep leg pain. 3 days later I went to the hospital and was diagnosed with a blood clot/DVT.; Approximately 2 weeks after the vaccine, inexperienced deep leg pain. 3 days later I went to the hospital and was diagnosed with a blood clot/DVT.; Approximately 2 weeks after the vaccine, inexperienced deep leg pain. 3 days later I went to the hospital and was diagnosed with a blood clot/DVT.; This is a spontaneous report from a contactable consumer. A 46-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 25Mar2021 13:00 (Batch/Lot Number: ER2613) as SINGLE DOSE for covid-19 immunisation. Medical history included none. The patient's concomitant medications were not reported. Approximately 2 weeks after the vaccine, inexperienced deep leg pain. 3 days later, the patient went to the hospital and was diagnosed with a blood clot/DVT. AE resulted in: [Emergency room/department or urgent care]. The patient received treatment for the events: Vitals taken, blood work, prescribed blood thinner. The patient underwent lab tests and procedures which included blood test: unknown result on an unspecified date ae treatment= Vitals taken, blood work , investigation: blood clot/dvt on 08Apr2021 3 days later I went to the hospital and was diagnosed with a blood clot/DVT, investigation: unknown result on an unspecified date ae treatment= Vitals taken, blood work. The outcome of the event was recovering. The patient does not have COVID prior vaccination, and was not COVID tested post vaccination. The patient has no known allergies.
46 2021-04-28 pulmonary embolism pulmonary embolism; pain on my stomach upper right side; difficulty breathing; This is a spontaneous... Read more
pulmonary embolism; pain on my stomach upper right side; difficulty breathing; This is a spontaneous report from a contactable consumer (patient). A 46-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EW0150), via an unspecified route of administration, administered in arm left on 05Apr2021 16:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medication included spironolactone taken for an unspecified indication, start and stop date were not reported. On Wednesday, 07Apr2021, the patient started experiencing pain on her stomach upper right side and had difficulty breathing. Thursday, 08Apr2021 the symptoms worsened so Friday morning, 09Apr2021, she went to Urgent Care and they sent her to the hospital ER. Friday evening, 09Apr2021 she has been admitted to the hospital with pulmonary embolism. She was released from the hospital on Sunday, 11Apr2021. Currently taking warfarin and enoxaparin injections. The patient underwent lab tests and procedures which included SARS-COV-2 test: negative on 09Apr2021. Therapeutic measures were taken as a result of all events. The outcome of the events was recovering.
47 2021-01-02 chest discomfort, oxygen saturation decreased BREATHING DIFFICULTY, STRIDOR, O2 SAT DROP, LIGHTHEADEDNESS, GENERALIZED ITCHING. AROUND 10 MIN POST... Read more
BREATHING DIFFICULTY, STRIDOR, O2 SAT DROP, LIGHTHEADEDNESS, GENERALIZED ITCHING. AROUND 10 MIN POST INJECTION. BEENADRY 100MG TAKEN, 4 DOSES OF TWO PUFF OF PROAIR HFA TAKEN. BREATHING NORMALIZED. ITCHING REMAINED, LIGHTHEADED SUBSIDED. GENERALIZED TOTAL BODY ITCHING CONTINUED THROUGH THE 3RD TODAY, LESSENDED YESTERDAT THE 2ND. BREATHING DIFFICULTY SOB AND TIGHTNESS RESUMED TODAY 1/3/2021 FOR ABOUT 2 HOURS BENADRYL 150 MG TAKEN , PEPCID 40 MG TAKEN, CLARATIN TAKEN PROAIR PUFFS TAKEN X 5 . CHEST TIGHTNESS CONTINUES, ITCHING CONTINUES AND BENADRYL CONTUNES TO BE USED WITH PUFFS FOR RELIEF. NORMAL MEDS TAKEN AS WELL XYZAL AND SIGULAR
47 2021-01-03 palpitations 12/23 within 2 mins after the vaccine I felt light headed and I felt like I was going to pass out m... Read more
12/23 within 2 mins after the vaccine I felt light headed and I felt like I was going to pass out my heart was beating really hard, it started to mellow out and my face swelled up about an hour after. I was told to go to the ER and I took oral Benadryl and it went away and did not return
47 2021-01-03 heart rate increased EE presented to EH with c/o hives to face and racing heart rate at 1445
47 2021-01-04 chest discomfort Approximately 20-25 min. post vaccination, employee reported chest tightness, flushing and light hea... Read more
Approximately 20-25 min. post vaccination, employee reported chest tightness, flushing and light headed. She was alert and oriented x 3. V/S: 120/72; pulse 140; resp 22; O2 sat 99% on RA; pupils equal and reactive; skin pink. Dr was notified and assessed the employee. Dr. ordered Benadryl 25mg PO which was administered at 1050. 1120 - o2 sat was 98% on RA; pulse 85; employee reported that chest tightness resolved and light headedness impoved, but not resolved; she continued to be flushed. Symptoms continud to improve. Employee remained in the observation area and was instructed to seek emergency treatment if symptoms returned, worsen or new symptoms occured. She verbalized understanding.
47 2021-01-04 heart rate increased high heart rate, blotchy/flushed skin, urticaria
47 2021-01-05 chest discomfort Chest tightness, flushing, arm tingling, lip swelling, warmth No shortness or breath, no chest pain... Read more
Chest tightness, flushing, arm tingling, lip swelling, warmth No shortness or breath, no chest pain, no palpitations, no tongue swelling, no rash, no redness, no nausea, vomiting or lightheadedness, no diaphoresis, no Hives improved in 1 hour and with Benadryl
47 2021-01-05 blood glucose increased, heart rate increased Pfizer-BioNTech COVID-19 Vaccine: Emergency Department Visit 01/07/21: 47 y.o. female who presents w... Read more
Pfizer-BioNTech COVID-19 Vaccine: Emergency Department Visit 01/07/21: 47 y.o. female who presents with complaints of fever, rapid heart rate and body aches that began around 1 PM this afternoon. Patient states that she received her second Covid vaccination yesterday and began developing symptoms today. States she had a temperature of 102. She is a nurse here in the rehabilitation center. She denies any cough, sore throat, abdominal pain that is new, vomiting, diarrhea or bloody stools. She has had no urinary symptoms. She denies any leg swelling or pain. No history of DVT or pulmonary embolism. No recent travel, immobilizations, surgeries, bedrest or history of malignancy. No hemoptysis. Again, no cough. Patient is taken no medications for the symptoms other than Tylenol which she states has not improved her symptoms. ROS negative. No pertinent history - Ovarian cyst, Spontaneous abortion, Uterine fibroid. She is given a liter normal saline 1 ibuprofen as she has allergies and side effects to multiple medications including pain medication and the patient did refuse any pain medications other than ibuprofen. Symptoms are consistent with side effects of the Covid vaccine. She does not appear ill appearing. She has no fever at this time. She does state that her symptoms are somewhat improved. Chest x-ray and labs are otherwise unremarkable. Encouraged the patient to get rest, drink plenty fluids and take ibuprofen and follow-up with her primary physician or return if symptoms worsen. This is the patient's second dose of vaccine for Covid.
47 2021-01-05 chest discomfort, chest pain Rec'd Covid vaccine 10 minutes afterwards, employee stated she felt weird in her chest, states she d... Read more
Rec'd Covid vaccine 10 minutes afterwards, employee stated she felt weird in her chest, states she didn't know if it was anxiety, state pain 4/.10 offered employee to be evaluated - refused requested to sit and be monitored BP 132/72, HR 71 POX 98% repeat vs employee states chest tight refused ED eval and RRT B/P 137/77 HR 70 POX 98% still refusing ED state just wants to be monitored for a few minutes 1745 BP 140/79 HR 70 POX 98% final VS at 1751 129/77, HR 70 POX 99% Employee states she feels more comfortable now and is ready to go home. She further states she knows what to do.
47 2021-01-06 hypertension Dizziness, UrticariaPruritus, HYPERtension, facial flushing, face felt warm
47 2021-01-06 fast heart rate Patient presented to clinic with complaints of generalized itching, status post COVID vaccination 2 ... Read more
Patient presented to clinic with complaints of generalized itching, status post COVID vaccination 2 days ago on 12/22. Patient also reporting flushing, intermittent tachycardia, and headache x2 days. Vitals were taken and follow: blood pressure 108/117, heart rate 111, spO2: 100%. Injection site observed to be red and tender. Patient reports history of allergies to tetracaine. Patient did not take medication OTC prior to coming in to clinic. Patient was transferred and admitted to the emergency department. In the emergency department was given benadryl and monitored for symptom improvement. Was discharged on the same day.
47 2021-01-07 chest pain Cp initially that resolved in seconds. Then severe muscle aches, fatigue, temp 1 week,excruciating j... Read more
Cp initially that resolved in seconds. Then severe muscle aches, fatigue, temp 1 week,excruciating joint pain continues now. Malaise.
47 2021-01-07 blood pressure increased Patient developed headache almost immediately after vaccine administration that persisted with sligh... Read more
Patient developed headache almost immediately after vaccine administration that persisted with slight worsening. Her BP was found to be elevated 4 hours later to 180s/100s; on manual recheck, was 172/96. Given signs and symptoms consistent with hypertensive urgency, she was sent to the emergency room. She has a history of well-controlled HTN and has been adherent to her medications (including the day of vaccine administration); she has had no recent episodes of uncontrolled BP.
47 2021-01-07 chest discomfort dizziness; tongue and lip tingling; welt on bottom lip; chest tightness; SOB with activity for 2-4 h... Read more
dizziness; tongue and lip tingling; welt on bottom lip; chest tightness; SOB with activity for 2-4 hours; itching; burning; diarrhea; redness traveling up arm into chest; This is a spontaneous report from a contactable nurse reporting for herself. A 47-years-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular in the right arm on 29Dec2020 03:30 at single dose for COVID-19 immunization. Medical history included breast cancer, allergy to peanuts, dogs, cats, the outdoors. Concomitant medication included tamoxifen (unknown manufacturer). On 29Dec2020 04:00 the patient experienced dizziness, tongue and lip tingling, welt on bottom lip, chest tightness, SOB with activity for 2-4 hours, itching immediately after injection (as reported), then burning, then redness traveling up arm into chest, and immediate onset of diarrhea. The outcome of the events was recovered. The patient received famotidine (PEPCID) and Cetirizine as treatment for the event. No other vaccine was administered in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination the patient had not been tested for COVID-19. Information on the lot/batch number has been requested.
47 2021-01-07 heart rate increased noticed an itch around that area (site of vaccine); heart started beating very fast; could not breat... Read more
noticed an itch around that area (site of vaccine); heart started beating very fast; could not breathe/difficulty breathing; light headaches; some soreness on the vaccine site; swelling on the area where she was vaccinated; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL0142), via an unspecified route of administration in left arm on 30Dec2020 at single dose for Covid-19 immunisation. Medical history included high cholesterol (it was under control. Diagnosed a couple years ago). There were no concomitant medications. She did her first dose of Pfizer COVID vaccine on 30Dec2020, and she had a little experience, she didn't tell the nurse at that time, but she went through her paperwork and decided to call Pfizer. When she got the shot, she was told to go to the next room to sit down for 15 minutes. When she went to the next room, 1 minute later, her heart started beating very fast, then she started to feel like she could not breathe/difficulty breathing for that moment. So, she tried to calm herself down and she focused on her phone to play games and to not think about it. After a couple minutes, it had gone. it was probably gone maybe about 10 minutes later. After 15 minutes, she went back to her office, everything was ok. Her heart was beating but not that fast, it was calmer than before, and she had a light headache, then some soreness on the vaccine site, on the left side, 'she thinks that is normal, right?' Clarifies soreness as swelling and painful on the area where she was vaccinated. She wanted to know, was she able to go back for the second shot, she was scheduled for 20Jan2021. Regarding light headache, she took some paracetamol (Extra Strength Tylenol, strength: 500mg, expiration date: Jun2024, lot number: SJC214). Soreness outcome: It went away, maybe the third day (02Jan2021), it was completely gone. The third day it was ok to completely sleep and lean on that side. She has recovered completely. The third day (02Jan2021), she noticed an itch around that area (site of vaccine), but she was not scratching it. The itching had gone, she had recovered completely. The outcome of heart started beating very fast and could not breathe was recovered on 30Dec2020, light headache was not recovered, soreness at vaccine site was recovered on 02Jan2021, itching at vaccine site was recovered on an unspecified date of Jan2021, and swelling on the area where she was vaccinated was unknown.
47 2021-01-08 chest pain 1 of 2, Pfizer-BioNTech COVID-19 Vaccine EUA received 1/7/21. Got hot flashes/sweaty, headache, left... Read more
1 of 2, Pfizer-BioNTech COVID-19 Vaccine EUA received 1/7/21. Got hot flashes/sweaty, headache, left chest/breast pain, fatigue, stuffy nose.
47 2021-01-08 heart rate increased Arms started tingling immediately after injection but did not think it was a significant response. A... Read more
Arms started tingling immediately after injection but did not think it was a significant response. As I was driving home my throat began to swell, my heart was racing, my chest got red and I was very shaky - this occured appx 50 minutes post injection.
47 2021-01-10 fast heart rate, hypotension 3 hours after receiving the vax. Got vax, went back to work and started feeling funny and then went ... Read more
3 hours after receiving the vax. Got vax, went back to work and started feeling funny and then went home and had rash to stomach, thighs, tachycardia, pulse about 130, hypotensive, swelling to tongue, eyes. Called provider when she got home and took Benadryl. Provider advised Pepcid, Benadryl, steroids x6 days. She is feeling ok now.
47 2021-01-10 hypertension ? cold feeling in chest ? itchy tongue, mouth and throat ? swelling in throat ? tongue progressed to... Read more
? cold feeling in chest ? itchy tongue, mouth and throat ? swelling in throat ? tongue progressed to becoming numb ? elevated BP
47 2021-01-10 hypotension Patient had headache, diaphoresis, low blood pressure and seizure. Patient got Tylenol for her head... Read more
Patient had headache, diaphoresis, low blood pressure and seizure. Patient got Tylenol for her headache and was observed for a few minutes. She was offered Benadryl but patient was allergic to Benadryl. She exhibited grand mal seizure twice. The ambulance was called after the second grand mal seizure.
47 2021-01-10 heart rate increased, fast heart rate, blood pressure decreased Received doe #1- left deltoid on 1/8/2021-within 10 minutes of receiving the vaccine had a "wave of... Read more
Received doe #1- left deltoid on 1/8/2021-within 10 minutes of receiving the vaccine had a "wave of warmth" come over my body and my heart rate suddenly increased to the 140's. Began to feel fullness in my throat and extremely tremulous. Nurse monitored my BP- elevated 140/101 with no hx of HTN. HR remained elevated for ~ 10 minutes than began to normalize. BP slowly began to decrease to more normal range. Tremors continued along with tingling sensation to extremities. Monitored by nurse for ~ 1 hour. Symptoms improved. Drove home. Extremely fatigued. Took dose of Benadryl. Fitful sleep with sporadic episodes of tachycardia on day #1. Following day 1/9- extreme fatigue, arm soreness, "spacey" feeling, weakness and nausea. Took additional doses of Benadryl. Slept 12 hours. Awoke on the following day ( 1/10), with persistent fatigue and nausea. Had insomnia that night and was restless, Awoke on 1/11 again with nausea, fatigue, arm soreness resolved but itchiness injection site.
47 2021-01-10 fast heart rate Within 1 minute after the injection I felt tachycardia and the tightness in my neck and an abnormal ... Read more
Within 1 minute after the injection I felt tachycardia and the tightness in my neck and an abnormal sensation in the back of my tongue. This lasted for about 20-25 minutes and then mostly resolved. I was monitored by the paramedics. I had normal vitals at the time of evaluation which was soon after notifying staff. After the 1st injection I had a similar episode, but I thought it was anxiety related.
47 2021-01-10 palpitations headache, fever, palpitations
47 2021-01-11 fast heart rate, chest discomfort Anaphylactic reaction; Flushed; Diaphoretic; redness and rash; hives on chest; Tachycardia; shortnes... Read more
Anaphylactic reaction; Flushed; Diaphoretic; redness and rash; hives on chest; Tachycardia; shortness of breath; Chest tightness; Dizziness; Headache; This is a spontaneous report from a contactable nurse, the patient. A 47-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL1283), via an unspecified route of administration on 08Jan2021 at 08:49 (at the age of 47-years-old) as a single dose for COVID-19 immunization. There were no known medical history or concomitant medications. The patient previously received the first dose of BNT162B2 on 18Dec2020 (Lot Number: EK5730) for COVID-19 immunization and experienced nausea, headache, and fatigue. On 08Jan2021, about 5-10 minutes after the second dose, the patient experienced anaphylactic reaction, flushed, diaphoretic, redness and rash, hives on chest, tachycardia, shortness of breath, and chest tightness, reported as life-threatening. She reported that these events occurred within less than 10 minutes of receiving the vaccine. She went to the emergency room and was treated with methylprednisolone (SOLUMEDROL), diphenhydramine hydrochloride (BENADRYL), famotidine (PEPCID), and epinephrine (MANUFACTURER UNKNOWN). She was sent home and prescribed methylprednisolone and epinephrine (EPI-PEN). Later on 08Jan2021, she experienced dizziness and headache, which were consistent. She stated she would most likely take ibuprofen (MOTRIN) as treatment (not specified if taken). The clinical outcomes of the flushed, diaphoretic, redness and rash, hives on chest, tachycardia, shortness of breath, and chest tightness were recovered on 08Jan2021; while the outcomes of the dizziness and headache were not recovered and that of the anaphylaxis was reported as recovering.; Sender's Comments: The reported information is limited. Based on the close temporal relationship and the description of the events, there is a reasonable possibility that the events are related to BNT162 vaccine. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
47 2021-01-11 chest discomfort Day of vaccination, arm tender, 7 hours after vaccination, Extreme Fatigue and Sore throat - loss of... Read more
Day of vaccination, arm tender, 7 hours after vaccination, Extreme Fatigue and Sore throat - loss of voice. Day after vaccination, Severe body pain - back, shoulders, hips, abdomen with Muscle aches, Headache, Mild Discomfort in chest and ribs when breathing, and General feeling of being unwell
47 2021-01-11 chest pain Patient had a headache the next morning 1/8/20 after reving the 2nd dose on 1/2/21. On 1/7/21, later... Read more
Patient had a headache the next morning 1/8/20 after reving the 2nd dose on 1/2/21. On 1/7/21, later in the morning, she began to have axilla pain that radiated to her chest on the site she rcvd. the vaccine. On 1/9/21 she had symptoms of weakness, cough & a great deal of fatigue. By Sunday, 1/10/21 she was feeling fine. Patient also had shortness of breath on 1/8 that resolved.
47 2021-01-11 heart rate increased Within a few minutes of 1st dose of vaccine I felt a sudden increase in HR - resolved on its own wit... Read more
Within a few minutes of 1st dose of vaccine I felt a sudden increase in HR - resolved on its own within 10 - 15 minutes; This is a spontaneous report from a contactable nurse (patient). A 47-years-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK5730), via an unspecified route of administration at left arm, on 19Dec2020 13:00 at single dose for COVID-19 immunization. Medical history included myasthenia gravis, allergy to IV contrast used for CT scans. Concomitant medication included pyridostigmine bromide (MESTINON), melatonin, ibuprofen (ADVIL). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Within a few minutes of the vaccine, on 19Dec2020 13:00, the patient felt a sudden increase in heart rate (HR) and resolved on its own within 10 to 15 minutes on 19Dec2020. No treatment received for the adverse events. No COVID prior vaccination, since the vaccination the patient hadn't been tested for COVID-19. It was not reported as serious.
47 2021-01-12 blood pressure increased Pfizer-BioNTech COVID-19 Vaccine On 1/13/2021, patient got her 2nd dose of vaccine. After receiving... Read more
Pfizer-BioNTech COVID-19 Vaccine On 1/13/2021, patient got her 2nd dose of vaccine. After receiving the dose, she felt warm, flushing and redness in chest area. Patient was brought to ED for evaluation at 9:52am. Treated as allergic reaction, got diphenhydramine 50 mg and famotidine 20 mg. At 11:20am redness was resolving and patient felt better. Her BP was high and got clonidine 0.3mg at 12:18pm. Patient was discharged at 12:31pm
47 2021-01-12 chest pain Reported fatigue, muscle aches, and chest pain.Followed up with her PCP for the chest pain. EKG unr... Read more
Reported fatigue, muscle aches, and chest pain.Followed up with her PCP for the chest pain. EKG unremarkable. Cardiologist to follow up.
47 2021-01-12 heart rate increased, blood pressure decreased, pallor, lightheadedness, fast heart rate feeling that I was going to pass out. faint; warm feeling starting on my right arm going down to my ... Read more
feeling that I was going to pass out. faint; warm feeling starting on my right arm going down to my left leg/warm feeling from my right leg up to my heart; Fast heartbeat; headache; blood pressure went down drastically; tachycardia; weak; looked pale; Anxiety; This is a spontaneous report from a contactable Other HCP (patient). A 47-year-old female (not pregnant) patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in right arm on 18Dec2020 10:00 at single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was hospital. Medical history included patient was alergic to environmental or insect allergens. No food no medication''. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included loratadine. The patient receive other vaccines within 4 weeks prior to the COVID vaccine was immunotherapy vaccine against mold, insect, mites on 02Dec2020 on both arms. It was reported ''3mins post injection: warm feeling starting on my right arm going down to my left leg. feeling that I was going to pass out. faint. goes and come. I was feeling that I was going to pass out like 3 times , but I was in a wheelchair.. Thanks God and warm feeling from my right leg up to my heart. Fast heartbeat, and weak and sudden headache. Symptoms goes and come. it last 15 mins. Once I was brought to ER.. they estabilize my tachycardia and gave me benadryl. I did get better, but still weak. Stay 2 hours for observation. By the time I got to ER, I was a little better. Physician diagnoses as Anxiety event. because I got estabilize and never got a rash, difficulty breathing. I am 100%, my body for whatever reason it could be, did not welcome the vaccine. and blood pressure went down drastically...i looked pale as they told me.''. Adverse events start date was reported on 18Dec2020 10:03 AM. Case was non-serious. Treatment received for the adverse events included medicine for tachychardia and Benadryl. AE warm feeling starting on my right arm going down to my left leg/warm feeling from my right leg up to my heart and feeling that I was going to pass out. faint resulted in: [Emergency room/department or urgent care]. The outcome of the events ''warm feeling starting on my right arm going down to my left leg/warm feeling from my right leg up to my heart'' and ''feeling that I was going to pass out. faint'' was reported as recovered. The outcome of other events was unknown. Information about Lot/batch number has been requested.
47 2021-01-13 fast heart rate Patient developed tachycardia to 170s and BP 160/100, headache, lightheaded, some difficulty breathi... Read more
Patient developed tachycardia to 170s and BP 160/100, headache, lightheaded, some difficulty breathing/shortness of breath but pt states it may be associated with the mask.
47 2021-01-13 hypertension Systemic: Nausea-Medium, Systemic: light headed, high blood pressure, shortness of breath-Medium; sy... Read more
Systemic: Nausea-Medium, Systemic: light headed, high blood pressure, shortness of breath-Medium; symptoms lasted 1 day
47 2021-01-13 heart rate increased Systemic: heart rate went up to 170bpm, felt hot, bp 160/80, came down to 109 bpm-Mild; symptoms las... Read more
Systemic: heart rate went up to 170bpm, felt hot, bp 160/80, came down to 109 bpm-Mild; symptoms lasted 1 day
47 2021-01-14 fast heart rate Pt experienced tachycardia and severe dizziness and associated nausea. BP 133/78, HR 94, sat 100. ... Read more
Pt experienced tachycardia and severe dizziness and associated nausea. BP 133/78, HR 94, sat 100. Symptoms passed after 10 minutes of observation. Sent patient home per her request.
47 2021-01-14 chest pain Symptoms began roughly 12 hours post vaccination Pain in left armpit into her chest and neck. Report... Read more
Symptoms began roughly 12 hours post vaccination Pain in left armpit into her chest and neck. Reports red solid rash in both armpits and a quarter sized red patch at the injection site. Notes One instance of diarrhea.
47 2021-01-14 palpitations The first night of the shot I had severe pain in both arms and could not sleep. The first 3 days I f... Read more
The first night of the shot I had severe pain in both arms and could not sleep. The first 3 days I felt tired and chilled, without fever. After the third day, symptoms subsided and I was back to normal activity. On the 7th day following the vaccine, I began having pain in the armpit of the left side. It was painful to have pressure on the area and to raise the arm overhead. It progressed on the the 8th day with increased pain and tenderness to touch. On the 9th day, I had severe pain with palpation and could feel a lump in the armpit. I have no redness, heat, or rash in the area. I went to my physician with concern because I have had a double mastectomy two years ago.
47 2021-01-15 fast heart rate, fainting, hypertension 1st dose only side effect was sore injection site - 2nd dose- 14 minutes after injection near sync... Read more
1st dose only side effect was sore injection site - 2nd dose- 14 minutes after injection near syncope episode with severe dizziness, nausea, tachycardia, high blood pressure. Benadryl 50 mg was administered. 45 minutes after Benadryl administration driven home and severe dizziness was present until next morning. 17 hrs post injection had severe flu like symptoms (chills, severe headache, muscle/body aches/no fever). Took Advil 800mg. At 48hrs no symptoms remain. At 69 hrs post injection had severe dizziness that is still present at 72.5 hrs post injection.
47 2021-01-15 heart rate decreased, palpitations Current as of day eleven: exhausted; face and hands numb; arms, legs, and head heavy; numbness has s... Read more
Current as of day eleven: exhausted; face and hands numb; arms, legs, and head heavy; numbness has spread through shoulders and upper back; challenges in arms and legs?very little control, hard to even lift arm to eat, to type?like heavy weight pressing down on arms and shoulders, like filled with lead and extreme stiffness; still have floating feeling off and on; still have tingling in face, arms, and hands; dizziness; mental fog; headaches; heart palpitations; hands swelling--difficult to use. This has been ongoing for eleven days now. Other symptoms can be found in report made to Pfizer site: (1/12/2021 at 2:27 pm)
47 2021-01-15 chest discomfort Day 1, Paresthesias in my feet, weakness in legs. Day 4, nasal congestion, feverish, malaise, anor... Read more
Day 1, Paresthesias in my feet, weakness in legs. Day 4, nasal congestion, feverish, malaise, anorexia, intermittent paresthesias, SOB, Chest Discomfort for 14 days straight, slightly better today.
47 2021-01-15 heart rate increased Increased Heart Rate and Tingling in the Arm and Dizzyness right after the vaccine. Dizzyness contin... Read more
Increased Heart Rate and Tingling in the Arm and Dizzyness right after the vaccine. Dizzyness continuted through out the day Increased Heart Rate had continued off and on, went to ER and have seen Cardiologist
47 2021-01-16 heart rate increased Fever 102, hr 120, decreased spo2 94, nausea, vomiting, fatigue, chills, body/joint ache, sore left ... Read more
Fever 102, hr 120, decreased spo2 94, nausea, vomiting, fatigue, chills, body/joint ache, sore left shoulder. Most symptoms lasted 36 hrs, nausea and fatuge lasted 48 hrs
47 2021-01-17 heart rate increased I was vaccinated at 3:30pm . At 5:27pm while driving home i felt a cold sensation in the back of my... Read more
I was vaccinated at 3:30pm . At 5:27pm while driving home i felt a cold sensation in the back of my neck and back of my throat which began spreading to the back of my head . My heart felt as if I was startled by something. I looked at my smart watch and my heart rate was 145. I began trembling and having abdominal cramping . The back of my head felt like I had swelling or collection of fluid. I opened my windows and began taking slow deep breaths to bring down my heart rate . It took quite a while to get it below 100. I felt as if I was going to pass out. After deep breathing for what felt like atleasr 15 to 20 minutes , my pulse came down and I closed my windows . As soon as my body warmed back up in the car , the symptoms returned and my heart rate went back up to 130s , 140s . I had to keep my windows down and deep breathe the entire way home which took an hour . My body was trembling. When I got home I felt as if I was too week to get out of the car . I still felt that startled feeling in my heart and was afraid of what could happen next . My lips and face were swollen. My lips were also slightly itchy. I called 911 for help . By the time they arrived my vital signs had stabilized but I still had swelling in my face and lips . My EKG , vital signs and oxygen levels checked out normal so I did not go to the ER. That night I took benadryl and Tylenol. Day 2 post vaccine the collection of fluid or swelling in the back of my head had now spread to the top . That night I had the feeling that my throat was swelling do I took benadryl and Tylenol and my face and lips were still slightly swollen . Day 3 post vaccine I woke up with slightly blurry vision. The swelling in my head now feels like it has encompassed my entire head and have a slight headache. I went to the urgent care requesting an MRI of the head and an epi pen . I was given Medrol dose pack , an RX for epi pen for emergencies and advised to continue benadryl and Tylenol. Day 4 post vaccine, slight headache continues. Slightly blurry vision
47 2021-01-18 palpitations, chest discomfort Started to have palpitations with some dizziness prior to second dose of the vaccine on 1/10/21, a... Read more
Started to have palpitations with some dizziness prior to second dose of the vaccine on 1/10/21, and then night of vaccine 1/11/2021, had chest pressure and palpitations. On 1/12 had worse symptoms , on 1/13 still had those symptoms but less. Came back to work on 1/14 and same symptoms . Came to ED on 1/13/21 had full work up neg EKG, neg CT scan, neg labs. Has Holter now. ( H/O covid in April 2020 had chest pressure when had covid. ) needs to follow up with PCP. No other PMH
47 2021-01-18 fast heart rate Tachycardia, Shortness of breath, headache, dizzyness, weakness, chills, nausea, fever
47 2021-01-19 heart rate decreased I received the vaccine in the afternoon of Jan 6th. Approximately 45 minutes to an hour later I felt... Read more
I received the vaccine in the afternoon of Jan 6th. Approximately 45 minutes to an hour later I felt lightheaded and like I was going to pass out. After a bit I felt a little better but remained dizzy and lightheaded. On the 7th I continued to feel dizzy and lightheaded throughout the day. I was sitting down on a call in the afternoon when my Apple watch vibrated and indicated my heart rate was below 50 for 10 minutes. I checked my heart rate and it was 38 - 48 BPM. On the morning of the 8th I reported my persistent symptoms to Dr. and an EKG was done showing a heart block. I have had bradycardia for the past year and likely the heart block but was not symptomatic until after I took the vaccine. See next pg
47 2021-01-20 palpitations, chest discomfort, chest pain, fast heart rate I received the 1st dose of vaccine on 12/16/20 and on that date through 12/18/20, I had severe arm s... Read more
I received the 1st dose of vaccine on 12/16/20 and on that date through 12/18/20, I had severe arm soreness and body aches. On 12/20/20, I had a sore throat, headache, body aches, and nasal congestion that continued through 12/24/20. On 12/25/20, I had extreme body aches, fatigue, left arm and leg numbness and tingling, SHOB, temp of 100.6, and back pain. On 12/27/20, I went to the ER for my symptoms and to be tested for COVID-19, to which I tested positive. They also tested me for strep and flu, both were negative. I also developed intermittent and random tachycardia (HR 120-150's), palpitations, chest tightness and chest pain. I am a RN and monitored my O2 Sats and HR frequently. My symptoms finally resolved enough for me to return to work on 1/11/21.
47 2021-01-20 palpitations weakness, dizziness, tingling to body, palpitations, skipping heart beat, pain to left leg, describe... Read more
weakness, dizziness, tingling to body, palpitations, skipping heart beat, pain to left leg, described her left leg veins appeared transiently engorged soon after 1st dose of pfizer covid vaccine
47 2021-01-22 lightheadedness Anaphylaxis with shortness of breath, throat tightness, dizziness and wheezing with near syncope.
47 2021-01-24 chest discomfort, fast heart rate 12 hours after my injection, by temperature shot up to 103. I experienced tachycardia with my pulse... Read more
12 hours after my injection, by temperature shot up to 103. I experienced tachycardia with my pulse ranging from 130-140. My heart rate went even higher. My normal pulse range is 60-70. My resting heart rate is range is 50-60. Additionally, I experienced chest pressure, chills. I'm still experiencing sudden burst of tachycardia and chest pressure today, seven days after my vaccine.
47 2021-01-24 chest pain Dizziness and Chest pain-- > ER
47 2021-01-24 chest discomfort, chest pain Injection administered at 7:39 am. Immediate sense of relaxation during post injection. 2-3 hours la... Read more
Injection administered at 7:39 am. Immediate sense of relaxation during post injection. 2-3 hours later experienced some lightheadedness and tiredness, by 3pm experienced chest tightness and burning, difficulty breathing, coughing, fatigue. Used my nebulizer every 4 hrs. Used rescue inhaler as needed Ventolin symptoms improved. 1/24/21 symptoms improved. Experienced some coughing and shortness of breath not as significant as day of vaccine. Recovery continues.
47 2021-01-25 hypertension Hypertension and headache within minutes of vaccination; symptoms resolved by 20-30 minutes
47 2021-01-25 fast heart rate Tachycardia, sweating, uncontrollable shaking, clamy hands and vomitimg
47 2021-01-26 blood clot Employee states that she received Dose #2 the day after the end of her menstrual cycle and that she ... Read more
Employee states that she received Dose #2 the day after the end of her menstrual cycle and that she began bleeding again after receiving her second dose and that it was a heavy and clotted cycle. She was advised to contact her OB/GYN
47 2021-01-26 palpitations Flushing, heart racing, itching in fingers
47 2021-01-26 chest discomfort She is now feeling little congestion like sinus; Tightness in chest; This is a spontaneous report fr... Read more
She is now feeling little congestion like sinus; Tightness in chest; This is a spontaneous report from a Pfizer-sponsored program. A contactable 47-year-old female Consumer (patient) reported that she received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on Jan2021 at single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient reported she is now feeling little congestion like sinus and tightness in chest in Jan2021 with outcome of unknown. She was not sure if it's from the vaccine. No treatment was received. The patient underwent lab tests and procedures which included weight: was like 200 pounds lbs on an unknown date. information on the batch/lot number has been requested.
47 2021-01-27 blood pressure decreased Immediately following shot my blood pressure drop felt like I was going to faint. With in a couple h... Read more
Immediately following shot my blood pressure drop felt like I was going to faint. With in a couple hours sore arm at injection site. With in 12 hours headache, slight fever achy body. 24 hours in my arm pit on the same Injection arm was swollen and uncomfortable and has remained so for 4 days so far.
47 2021-01-27 chest pain Roughly 10-13 minutes after injection patient reports numbness and tingling in arm of administration... Read more
Roughly 10-13 minutes after injection patient reports numbness and tingling in arm of administration. Also complains of sharp chest pain. VS-152/92, 92, 24, 99% on RA. Advised to go to ER for further evaluation. Spouse came and picked patient up and took to the ER she did not want to go via ambulance.
47 2021-01-28 chest pain, chest discomfort Woke up at 07:20 which chest tightness/pain and uncontrollable shaking. Temperature was 102 with h... Read more
Woke up at 07:20 which chest tightness/pain and uncontrollable shaking. Temperature was 102 with hospital grade temporal thermometer. Pulse rate of 140 and POX of 96. At 07:23 took 650mg Tylenol and 50mg oral diphenhydramine with 16 oz water. Chest tightness subsided around 10 minute mark and shaking stopped after one hour. Sleep from 10:00-16:00. Woke up with a headache and mental confusion.
47 2021-01-31 nosebleed Individual developed a severe headache followed by a bloody nose post-vaccination with second dose. ... Read more
Individual developed a severe headache followed by a bloody nose post-vaccination with second dose. Individual reports continuing intermittent headaches followed by a bloody nose. She is to follow up with an ENT specialist. Patient also experiencing eye droop of right-side along with facial swelling of that side.
47 2021-01-31 fast heart rate my right arm started to feel like it was on fire; This feeling quickly spread up my neck and across ... Read more
my right arm started to feel like it was on fire; This feeling quickly spread up my neck and across my chest; red splotchy rash; right side of my head was tingling; I was mildly tachycardic; This is a spontaneous report from a contactable other Health Professional (patient). A 47-year-old female patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL1284), via an unspecified route of administration on 06Jan2021 12:30 at single dose for covid-19 immunisation. Medical history included allergies to adhesive and nickel. Patient did not have COVID prior vaccination. Patient did not have COVID tested post vaccination. There were no concomitant medications. It was reported that the day after vaccination, patient's right arm started to feel like it was on fire. This feeling quickly spread up neck and across chest and this area had a red splotchy rash. The right side of head was tingling. Patient took 50 mg diphenhydramine hydrochloride (BENADRYL) and headed to ER (Emergency Room) where patient received Dexamethasone. Patient was mildly tachycardic. Above events started on 07Jan2021 at 12:30. Outcome of the events was resolved.; Sender's Comments: The events are considered related to the suspect product based on the strong temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
47 2021-02-01 palpitations, hypertension discomfort in my sternum; trouble breathing; chest congestion; increased weakness; shakiness in my l... Read more
discomfort in my sternum; trouble breathing; chest congestion; increased weakness; shakiness in my legs; Within 10mins I was feeling dizzy; increase palpitation; I told the nurse she checked my blood pressure. It was 157/87; This is a spontaneous report from a contactable healthcare professional (patient). A 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number and expiration date unknown), via an unspecified route of administration on the right arm on 15Jan2021 15:45 at a single dose for an COVID-19 immunization at a hospital. Medical history included GERD. There were no concomitant medications. On 15Jan2021 at 15:45 (reported as within 10 mins), the patient felt dizzy and increase palpitation. The patient told the nurse and she checked her blood pressure, it was 157/87. After 15 mins of vaccine infusion (16:00), she came back home and increased weakness with shakiness in legs noted. After 2 hrs. (18:00) all symptoms were gone. The next morning (16Jan2021), the patient had discomfort in her sternum. By late afternoon, she had trouble breathing with chest congestion. The patient took 3 puffs of inhaler so she can breathe. The patient mentioned that her inhaler is expired, it was given to her 3 years ago. She didn't want to use it but used it anyway so she can sleep. The events dizzy, palpitation, blood pressure high, weakness, shakiness, and discomfort in sternum were not treated. The outcome of the events weakness and shakiness was recovered on 15Jan2021 at 18:00 while the other events were unknown. Information about lot/batch number has been requested.
47 2021-02-01 palpitations, heart rate increased throat closing; tingling immediately in left arm; rapid heartbeat; This is a spontaneous report from... Read more
throat closing; tingling immediately in left arm; rapid heartbeat; This is a spontaneous report from a contactable healthcare professional, the patient. A 47-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL 1283), intramuscular in the left arm on 08Jan2021 at 17:00 (at the age of 47-years-old) as a single dose for Covid-19 immunization. Medical history included migraines. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not have any allergies to medications, food or other products. The patient's concomitant medications included minocycline (MANUFACTURER UNKNOWN) for unknown indications from unknown date and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. On 08Jan2021 at 17:00, the patient experienced tingling immediately in left arm following injection, rapid heartbeat and throat closing. The patient was treated for the throat tightness, paraesthesia and heart rate increased which included diphenhydramine (BENADRYL), oral steroids, EKG and blood pressure monitoring. The events did initiate an emergency room visit. The clinical outcome of the events throat tightness, paraesthesia and heart rate increased was recovered with sequel. It was also reported that since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported "throat closing" and the administration of COVID 19 vaccine, BNT162B2, based on the reasonable temporal association and lacking alternative explanations. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
47 2021-02-03 chest pain, palpitations, chest discomfort Immediately upon having the injection administered, my heart rate sped up. I sat down within the wai... Read more
Immediately upon having the injection administered, my heart rate sped up. I sat down within the waiting area for monitoring thinking that if I sat down for a bit, that it would maybe pass . Within about 7 minutes of that, I began to feel the back, left side of my throat go numb. I began to get very dizzy after that and I alerted one the pharmacy Nurses, that was on duty. She asked for me to open My mouth so that she could see if my throat was swelling & said that she didn?t see anything and I was told by her that it may just be anxiety that I was experiencing and she asked me to take a few sips of water and to try and relax a bit. She resumed helping others, while I continued to sit there. It was then when I experienced a heavy onset of chest tightness and the inability to breathe. The left side of my face and jaw went numb & that?s when I really knew something was wrong. I was taken outside for some fresh air and realize that I was so nauseous, more dizzy, very weak upon standing and I told the same nurse and another young lady that was assisting me that I felt like I was going to pass out and to please call EMS for me . At that time, I lost temporary feeling in all 4 limbs and I began to experience heart palpitations . I was having some trouble swallowing and I was laid down and. My blood pressure was taken. Blood Pressure was 235/130 and it was taken several times until emts arrived. It was then 200/120 and 180/112 by the time help arrived. Overall I experienced burning sensation in chest and abdomen, facial weakness and numbness left side fever loose stools weakness, shortness of brEath and chest tightness blurred vision felt like I?m out of touch with reality Malaise restless and the loss in feeling in my Limbs are slowly returning body And muscle and joint aches and pains and wheezing bouts
47 2021-02-03 hypertension Itchy, lightheaded, high blood pressure, seeing stars, diarrhea
47 2021-02-03 palpitations Patient became dizzy and nauseous after receiving 2nd dose of Pfizer vaccine. Stated body felt "heav... Read more
Patient became dizzy and nauseous after receiving 2nd dose of Pfizer vaccine. Stated body felt "heavy" and hard to keep eyes open. Also reported feeling like heart was "racing"
47 2021-02-03 palpitations Profound weakness; severe muscle and bone pain; severe muscle and bone pain; crushing headache with ... Read more
Profound weakness; severe muscle and bone pain; severe muscle and bone pain; crushing headache with severe ocular pressure; palpitations; dizziness; Tingling and numbness to hands and feet; Tingling and numbness to hands and feet; Vein engorgement and swelling of left leg; Vein engorgement and swelling of left leg; right abdominal and flank pain; right abdominal and flank pain; crushing headache with severe ocular pressure; This is a spontaneous report from a contactable health care professional nurse, the patient (patient). A 47-years-old non-pregnant female patient (nurse) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: El3249), via an unspecified route of administration in the left arm on 19Jan2021 at 15:30 as a single dose, for COVID-19 vaccination. The vaccine was administered in a Nursing Home/Senior Living Facility. Medical history included asthma and known allergies (details not provided). Concomitant medication included albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]). No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 19Jan2021 at 15:30, the patient experienced Profound weakness, dizziness, palpitations, severe muscle and bone pain, tingling and numbness to hands and feet, vein engorgement and swelling of left leg, right abdominal and flank pain, crushing headache with severe ocular pressure. The events resulted in an emergency room visit and physician office visit. No treatment was given for the events. The clinical outcome of weakness, dizziness, palpitations, severe muscle and bone pain, tingling and numbness to hands and feet, vein engorgement and swelling of left leg, right abdominal and flank pain, crushing headache with severe ocular pressure was not recovered. No follow-up attempts are possible. No further information is expected.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
47 2021-02-03 hypertension Sudden onset of Hypertension with out history; This is a spontaneous report from a contactable nurse... Read more
Sudden onset of Hypertension with out history; This is a spontaneous report from a contactable nurse (patient). A 47-year-old female patient received first single dose of BNT162B2 (Pfizer, Solution for injection, batch/lot number and exp date not reported), via an unspecified route of administration (Vaccine location: Left arm) on 11Jan2021 07:15 for Covid-19 immunisation. Facility where the most recent COVID-19 vaccine was administered: Hospital. Medical history included allergy to beer. The patient was not pregnant. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no other medications patient received within 2 weeks of vaccination. The patient experienced sudden onset of hypertension (without history) on 12Jan2021 06:00. Event required doctor or other healthcare professional office/clinic visit. The event was considered as non-serious by the reporter. Treatment received for the adverse event included oral lisinopril 10 mg. Nasal swab (PCR) on 18Jan2021 was negative. The patient had not recovered from sudden onset of hypertension at the time of reporting. Information about lot number and expiry date for the suspect product will be requested in follow-up attempts.
47 2021-02-03 hypertension Warm , tingly arm, dizziness, lightheaded, tongue swelling, difficulty swallowing, high blood pressu... Read more
Warm , tingly arm, dizziness, lightheaded, tongue swelling, difficulty swallowing, high blood pressure
47 2021-02-04 blood pressure increased getting jittery; tense; antsy; keyed up; blood pressure: 154/85; This is a spontaneous report from ... Read more
getting jittery; tense; antsy; keyed up; blood pressure: 154/85; This is a spontaneous report from a contactable pharmacist, reporting for herself. A 47-year-old non-pregnant female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EL3246, via an unspecified route of administration on 14Jan2021 at 16:30 (at the age of 47 years old) as a single dose in the left arm for COVID-19 vaccination. Medical history included Stage IV endometriosis, AVNRT/SVT cardiac arrhythmia, survivor of clear cell renal cell carcinoma (treated 2010), allergies: Lupron (rash), environmental allergies (grasses, trees, weeds, molds, animal dander), all from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included Drospirenone, ethinyl estradiol, betadex clathrate (YAZ), levonorgestrel (MIRENA), cetirizine hydrochloride (ZYRTEC), metoprolol succinate (TOPROL XL), and unspecified multivitamin. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Jan2021 at 21:30, the patient starting getting jittery, tense, antsy, "keyed up". She took her blood pressure and it was 154/85. One hour later it was 148/89. Two hours later it was 158/88. The next day, on 20Jan2021 (day 6 post-vaccine), the blood pressure reading in the morning upon arising was 154/86. At 5 pm, it was 166/91. She doubled up on metoprolol succinate (TOPROL XL) dose, which didn't seem to alter the blood pressure at all, based on the home monitor readings. On day 7 post-vaccine (21Jan2021) it is as if the preceding day with the elevated blood pressure never happened; she felt perfectly fine and normal. Day 7 post vaccine, blood pressure resumed normal levels (115-120/70-80). The patient did not receive treatment for the events. The clinical outcome of getting jittery, tense, antsy, "keyed up", and blood pressure: 154/85 was recovered on an unspecified date in Jan2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
47 2021-02-06 palpitations, chest discomfort 2 hours after vaccine, I had an anaphylactic reaction. I had an extremely difficult time breathing w... Read more
2 hours after vaccine, I had an anaphylactic reaction. I had an extremely difficult time breathing with chest tightening, heart racing, numbness and tingling on my mouth and chin, tongue swollen and turned grey in a matter of a few minutes. I took Benadryl, an epinephrine pen, and a nebulizer and began to start feeling better in 15 minutes. Following the 2 weeks I felt nauseous, chills, cold sweat, lightheaded, weak, tired, headache and pain in arm/shoulder.
47 2021-02-07 palpitations Numbness in left leg severe enough that could not walk properly. Heart was racing per patient, Pul... Read more
Numbness in left leg severe enough that could not walk properly. Heart was racing per patient, Pulse felt normal approx. 80bpm. Left foot was tingly. Wheelchaired to Emergency Room.
47 2021-02-07 palpitations Patient received injection and then started feeling heart racing like palpitation, dry mouth, flushe... Read more
Patient received injection and then started feeling heart racing like palpitation, dry mouth, flushed feelings. Patient stated she did not eat breakfast and has not been drinking water. Patient also states she has a history of panic attacks, anxiety, IBS, Cevo. Patient did have c/o a slight headache however, felt it was due to lack of water intact today. Patient sat for remaining 30 minute observation with nurse and provider on duty and was given water. At the end of the 30 minutes patient had decreased symptoms and stated her husband drove her. Provider gave ok for patient to take a prescribed Lorazepam when arriving home today. Patient discharged home after 30 minute observation period was complete with husband.
47 2021-02-08 blood pressure increased, chest discomfort, heart rate increased 1:30 pm EE felt woozy "doesn't feel right" HR 120 1:35 pm Throat felt ? HR 140 BP 130/60 SPO2 99% 1:... Read more
1:30 pm EE felt woozy "doesn't feel right" HR 120 1:35 pm Throat felt ? HR 140 BP 130/60 SPO2 99% 1:40 pm Chest tightness HR 118 BP 146/67 SPO2 100% 1:48 pm Benadryl given po at 1:45pm HR 100 BP 127/68 SPO2 100% 1:55 pm HR 100 BP 125/68 SPO2 100% 2:00 pm HR 102 BP 122/67 SPO2 100% 2:05 pm "Feeling OK" HR 96 BP 125/66 SPO2 98% 2:15 pm HR 99 BP 121/64 SPO2 100%
47 2021-02-08 chest discomfort Hives, chest tightness, sinus drainage, and pressure
47 2021-02-09 heart rate increased Fever up to 102.5; nausea; dizziness; muscle aches; joint aches; headache; fatigue; weakness; heart ... Read more
Fever up to 102.5; nausea; dizziness; muscle aches; joint aches; headache; fatigue; weakness; heart rate racing; injection site pain; This is a spontaneous report from a non-contactable consumer (patient herself). A 47-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN5318), via an unspecified route of administration (left arm), on 21Jan2021 16:30, at single dose, for covid-19 immunization. The patient has no medical history and has no known allergies. The patient's concomitant medications were not reported. The patient experienced fever up to 102.5, nausea, dizziness, muscle aches, joint aches, headache, fatigue, weakness, heart rate racing, and injection site pain - all on 22Jan2021 02:00. No treatment was received for the events. The patient had not recovered from the events at the time of the report. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID prior vaccination and have not been COVID tested post vaccination. No follow-up attempts are possible. No further information is expected.
47 2021-02-09 fainting, hypertension Systemic: Fainting-Medium, Systemic: Other- High BP
47 2021-02-14 fainting syncopal episode; Swollen lymph nodes in left neck and left arm pit; Nausea within a couple of hours... Read more
syncopal episode; Swollen lymph nodes in left neck and left arm pit; Nausea within a couple of hours of vaccine /continued nausea; Fatigue; fever; chills; headache; dizziness; This is a spontaneous report from a contactable other health professional (patient). A 47-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL1283), via an unspecified route of administration in left arm on 27Jan2021 11:30 at single dose for COVID-19 immunization. Medical history included very infrequent anxiety and headaches, only after illness. Concomitant medication included sertraline, ethinylestradiol, norethisterone acetate (JUNEL), fluticasone propionate (FLONASE). The patient previously took prochlorperazine maleate (COMPAZINE) and experienced allergies to Compazine. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL0140), via an unspecified route of administration at the age of 47-year-old in left arm on 06Jan2021 10:30 at single dose for COVID-19 immunization. The patient experienced nausea within a couple of hours of vaccine. The patient experienced fatigue, fever, chills, headache, continued nausea, dizziness with 1x syncopal episode, swollen lymph nodes in left neck and left arm pit, mostly resolved after 3 days. She had still with headache. All events occurred on 27Jan2021 14:30. The events resulted in Doctor or other healthcare professional office/clinic visit. No treatment received for the events. The patient did not receive any other vaccines in four weeks. The patient was no pregnant. The patient had no COVID prior vaccination. The patient had not been tested for COVID-19 post vaccination. The outcome of the event headache was not recovered and the outcome of the other events was recovering.; Sender's Comments: Based on a compatible temporal relationship causality between event syncopal episode and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
47 2021-02-16 heart rate increased shortness of breath and rapid heart rate that would not resolve in greater than 20 minutes of observ... Read more
shortness of breath and rapid heart rate that would not resolve in greater than 20 minutes of observing and oxygen
47 2021-02-21 heart rate increased About 20 minutes after vaccination, lips and tip of nose went numb, tongue felt big and fuzzy, stron... Read more
About 20 minutes after vaccination, lips and tip of nose went numb, tongue felt big and fuzzy, strong metallic taste in mouth, felt flushed and HR was elevated. Received 50mg of Benadryl.
47 2021-02-21 palpitations Developed itchiness on face and mild palpitation 20 minutes after injection Developed headache an... Read more
Developed itchiness on face and mild palpitation 20 minutes after injection Developed headache and injection site soreness 12 hours after injection Developed dizziness about 20 hours after injection Developed itchiness, redness, and welt below the injection site 3 days after injection and lasted for about 5-7 days
47 2021-02-21 chest pain Received 2nd vaccine on 2/19/21 and started having fatigue the next day that progressed into Chest p... Read more
Received 2nd vaccine on 2/19/21 and started having fatigue the next day that progressed into Chest pain that radiates into shoulders.
47 2021-02-22 fast heart rate Tachycardia,fever,malaise,fatiuge,headache,congestion, inflamed thyroid
47 2021-02-23 heart rate increased Heart rate spiked after vaccine. Received shot at 4:30pm. At 4:45 was cleared to leave and left the ... Read more
Heart rate spiked after vaccine. Received shot at 4:30pm. At 4:45 was cleared to leave and left the vaccine facility. At 4:56, the heart rate monitor on my watch alerted me to an abnormally high heart rate of 153. It went up to 155 before gradually returning to my normal heart rate of around 55. The spike and return to normal happened over the course of about 10 minutes. No shortness of breath or other symptoms to report.
47 2021-02-23 heart rate increased Immediately post vaccination patient complained of heart rate increase to the high 90's, low 100's. ... Read more
Immediately post vaccination patient complained of heart rate increase to the high 90's, low 100's. Patient waited an additional 15 minutes and heart rate normalized back to the 80's.
47 2021-02-25 blood pressure increased Around 4:00pm-4:15pm, began pin and needles discomfort in joints between fingers on right hand. Betw... Read more
Around 4:00pm-4:15pm, began pin and needles discomfort in joints between fingers on right hand. Between 4:15pm-4:30pm, the palms of both hands, and my left wrist began to itch uncontrollably. Reported to EMT on duty to exam. Experienced elevated blood pressure of 163/93. No itching of throat nor any other body parts. Was advised to take Benadryl.
47 2021-02-25 fainting Rigors and severe back pain; Rigors and severe back pain; syncope; prolonged PT; Loss of work as a p... Read more
Rigors and severe back pain; Rigors and severe back pain; syncope; prolonged PT; Loss of work as a physician for 2.5 weeks; This is a spontaneous report from a contactable physician (patient) A 47-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 11Jan2021 12:30 at single dose for COVID-19 immunisation. Medical history included gastrooesophageal reflux disease and allergies. The patient was not pregnant. Concomitant medication included lansoprazole (PREVACID). The patient experienced rigors and severe back pain, syncope, prolonged pt and loss of work as a physician for 2.5 weeks on 12Jan2021 with outcome of recovered with sequelae in Feb2021. The events resulted in Emergency room/department or urgent care, Hospitalization, Disability or permanent damage. The patient was hospitalized due to the events for 2 days. The patient received steroids, pain meds, muscle relaxers as treatment for the events. The patient did not have COVID-19 prior to vaccination and was not covid tested post vaccination. Information on the Lot/Batch number has been requested.; Sender's Comments: Based on a compatible temporal relationship and known product safety profile causality between event chills and syncope and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), cannot be excluded. The events prolonged PT and loss of work as a physician for 2.5 weeks are attributed to intercurrent conditions that were unlikely related to BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE). The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
47 2021-02-28 chest discomfort After receiving her vaccine, client complained of itchy throat, tightness of chest and throat. Vita... Read more
After receiving her vaccine, client complained of itchy throat, tightness of chest and throat. Vital signs obtained B/P 151/98, HR 80, O2 sat 100%.
47 2021-02-28 heart rate increased, blood pressure increased At roughly 2:30pm, started with nausea and chills, went home went to bed. Severe muscles cramping... Read more
At roughly 2:30pm, started with nausea and chills, went home went to bed. Severe muscles cramping and soreness. Went to ER for this was perscribed naproxen for inflammation. Still nothing helped. Went back to ER with elevated heart rate and BP due to the discomfort was accused of being a pill seeker. I just want the pain and muscle cramps to stop. I hurt from head to toe.
47 2021-02-28 chest discomfort Pfizer-BioNTech COVID-19 Vaccine EUA: Vaccine recipient reported chest tightness during observation ... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA: Vaccine recipient reported chest tightness during observation period. Vaccine recipient was monitored by EMS. No further intervention needed.
47 2021-02-28 chest discomfort Throat tightness, chest tightness-cleared by EMS
47 2021-03-02 palpitations Palpitations, throat tightness. Evaluated by EMS-Cleared
47 2021-03-02 chest pain extreme chills, nausea, chest pain, shortness of breath, fever of 104.3 that would only come down to... Read more
extreme chills, nausea, chest pain, shortness of breath, fever of 104.3 that would only come down to 103 with alternating Tylenol and Ibuprofen, body aches, lasted 3 days
47 2021-03-03 chest pain Over night on the night following the vaccination, I had headache, body aches, malaise and insomnia.... Read more
Over night on the night following the vaccination, I had headache, body aches, malaise and insomnia. Throughout the next day (1/13/21), I continued to have headache, body aches, and malaise as well as objective fever (up to about 101.5 degrees F), fatigue, dyspnea on exertion and lightheadedness. Later in the day (about 5:00pm) I developed significant shortness of breath at rest and chest pain. Later that evening I went to the Emergency Department because of concern over my extreme and persistent shortness of breath and chest pain. In the E.D. they did the following tests: EKG (normal), oximetry (normal), Portable Chest Xray (normal), rapid COVID test (normal), cardiac enzymes (normal), D-DIMER (ELEVATED), other bloodwork (normal). Because of the elevated D-dimer, a CT angiogram of the chest was performed to rule-out pulmonary embolism. The CT showed enlarged lymph nodes, but no evidence of pulmonary embolism. I was discharged home. By the next morning (1/14/21) I was feeling much better. And by the afternoon of 1/14/21 I was feeling completely back to normal without any symptoms.
47 2021-03-03 fast heart rate, palpitations Tachycardia. Laying in bed watching TV, suddenly my heart was racing. I just stayed in bed and it we... Read more
Tachycardia. Laying in bed watching TV, suddenly my heart was racing. I just stayed in bed and it went away after a few minutes. Numbness in the arm: started that night and I would get numbness about every other day. Numbness lasts for about 10 hours and comes and goes throughout the day. About 6 weeks after the vaccine, i got numbness in the left leg. Now the numbness in the arm is pretty much gone but the leg numbness is there.
47 2021-03-04 fibrin d dimer increased About 2 days after receiving the second dose I started experiencing redness and pain at the injectio... Read more
About 2 days after receiving the second dose I started experiencing redness and pain at the injection site. It was also warm to the touch. It was about almost 2 in in diameter. It got worse on the next day and it slowly started getting better, it went away in about 4 days. Then I had a gallbladder surgery that was scheduled on 01/29/2021. On 02/03/2021 I was feeling excruciating pain that I believe it was related to the gallbladder surgery. I went to the ER, the same hospital where I got the vaccine at and they ran a lot of tests on me, blood work, CT scans, ultrasounds and they told me my D Dimer was elevated: 2371. They attributed it to my recent surgery and told me to FU with my PCP. When I FU'd with my PCP Dr., she requested new blood work and this time my D Dimer was even higher than the results at the ED: 2610. That was on 03/01/2021. She is trying to get me in the Clinic she is concerned about cancer. I think it might be something regarding the vaccine.
47 2021-03-04 palpitations heart racing, "just feeling wierd"- Evaluated by EMS-Cleared
47 2021-03-14 cerebrovascular accident PATIENT UNRESPONSIVE. SPOUSE REPORTING FOR PATIENT, PER SPOUSE, "My wife felt bad after the first sh... Read more
PATIENT UNRESPONSIVE. SPOUSE REPORTING FOR PATIENT, PER SPOUSE, "My wife felt bad after the first shot, she complained of body soreness, weakness and headaches that did not go away until she had the stroke on 03/12/2021". Patient is now hospitalized and unresponsive.
47 2021-03-18 deep vein blood clot Woke up with pain in left leg lower calf on February 26 one week after my second vaccine. Had pain ... Read more
Woke up with pain in left leg lower calf on February 26 one week after my second vaccine. Had pain and throbbing in leg couldn?t sleep with pain so on the evening of March 3rd I went to urgent care . Doctor didn?t think it was blood clot because I had no swelling or redness in my leg but gave me a script for ultrasound. I couldn?t get an appointment until the morning of March 5th . Was diagnosed with a very large blood clot in lower leg going up past my knee. I am now in Eliquis blood thinner for 3 months while they run tests
47 2021-03-24 fainting overlying skin with faint hyperpigmentation and feels like sandpaper on palpation; cutaneous/subcuta... Read more
overlying skin with faint hyperpigmentation and feels like sandpaper on palpation; cutaneous/subcutaneous reaction at the site of the first injection - pruritic, erythematous, indurated, warm; cutaneous/subcutaneous reaction at the site of the first injection - pruritic, erythematous, indurated, warm; overlying skin with faint hyperpigmentation and feels like sandpaper on palpation; cutaneous/subcutaneous reaction at the site of the first injection - pruritic, erythematous, indurated, warm; This is a spontaneous report from a contactable physician. A 47-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6200), second dose, intramuscular, administered in left arm on 19Feb2021 17:00 as single dose for covid-19 immunisation. Medical history included depression, ADHD (attention deficit hyperactivity disorder), obesity, allergic rhinitis, penicillin allergy (rxn in childhood - suspect not actually allergic). Concomitant medications included Fluoxetine, Bupropion, Adderall, Cetirizine and Ibuprofen. On 19Jan2021 11:00 patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) Lot number=EL9264, intramuscular on left arm. In the hours following the second injection patient developed a cutaneous/subcutaneous reaction at the site of the first injection - pruritic, erythematous, indurated, warm, size approx 12mm x 5mm, minimal depth below skin surface. Itching waxed and waned in intensity, was worst early on, but still had some occasional itching two days later at which point lesion was sort of like a pin-point sized scab in appearance. Induration gradually resolved but was still detectable the day after the injection. Currently (4 days after injection) overlying skin with faint hyperpigmentation and feels like sandpaper on palpation, no warmth, induration, or erythema. (Healing, non-concerning, is sort of like a not-quite-a-scab, 8mm x 1mm - though I did not note any abrasions or watery exudate while it was symptomatic. On an unspecified date the events outcome was recovered. No follow-up attempts are possible. No further information is expected.
47 2021-03-30 chest pain it triggered an exacerbation (attack) of my underlying genetic disease (acute intermittent porphyria... Read more
it triggered an exacerbation (attack) of my underlying genetic disease (acute intermittent porphyria); it triggered an exacerbation (attack) of my underlying genetic disease (acute intermittent porphyria); after each vaccination, 12 hours later typical side effects developed (low grade fever, chills, muscles pain); after each vaccination, 12 hours later typical side effects developed (low grade fever, chills, muscles pain); after each vaccination, 12 hours later typical side effects developed (low grade fever, chills, muscles pain); This was characterized by severe abdominal pain; headache; extreme dizziness; chest pain; brain fog; numbness in feet; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient (not pregnant) received bnt162b2, via an unspecified route of administration, in left arm on 03Mar2021 09:00 (second dose, Batch/Lot Number: EN6203), via an unspecified route of administration in left arm on 09Feb2021 12:45 (first dose, Lot number: EC(L?)8982) both as single dose for covid-19 immunization. Medical history included acute intermittent porphyria, migraine, hypertension (HTN), dermatitis contact (Known allergies: adhesives (contact dermatitis)), COVID-19 (If COVID prior vaccination: Yes) all from unknown date and unknown if ongoing. Concomitant medications included givosiran sodium (GIVLAARI); lisinopril; hemin (PANHEMATIN DRY); zolmitriptan taken for an unspecified indication, start and stop date were not reported. The patient experienced after each vaccination, 12 hours later typical side effects developed (low grade fever, chills, muscles pain), it triggered an exacerbation (attack) of her underlying genetic disease (acute intermittent porphyria), this was characterized by severe abdominal pain, headache, extreme dizziness, chest pain, brain fog, numbness in feet all on 03Mar2021 20:00. After each vaccination, 12 hours later typical side effects developed (low grade fever, chills, muscles pain) and it triggered an exacerbation (attack) of her underlying genetic disease (acute intermittent porphyria). This was characterized by severe abdominal pain, headache, extreme dizziness, chest pain, brain fog, numbness in feet. She received treatment for the attack and symptoms resolved after several days. The treatment included: Intravenous treatment with hemin (PANHEMATIN). The events resulted in doctor or other healthcare professional office/clinic visit. The outcome of events was resolved. Facility type vaccine was hospital. No other vaccine in four weeks. No COVID tested post vaccination.
47 2021-04-09 heart rate increased, blood pressure increased Blood pressure went up; Heart Rate exceeded 100 beats a minute five minutes after the injection; Thi... Read more
Blood pressure went up; Heart Rate exceeded 100 beats a minute five minutes after the injection; This is a spontaneous report from a contactable other hcp (patient). A 47-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in Arm Left on Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included asthmatic from an unknown date and unknown if ongoing. The patient don't have heart problems or blood pressure problems. The patient's concomitant medications were not reported. The patient experienced heart rate exceeded 100 beats a minute five minutes after the injection and blood pressure went up on an unspecified date in Mar2021. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient was hospitalized for 1 day due to the events. Therapeutic measures were taken as a result of the events which included Heart monitor/ IV for flushing. The patient did not recover from the events. Information about lot/batch has been requested.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug to the reported events "Blood pressure went up" and "Heart Rate exceeded 100 beats a minute five minutes after the injection" cannot be completely excluded based on temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identifies as part of this review, as well as any appropriate action in response, will be promptly notifies to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
47 2021-04-13 blood glucose increased hit the timer on my watch when the injection was given. By minute 2 my body was hot and my throat wa... Read more
hit the timer on my watch when the injection was given. By minute 2 my body was hot and my throat was starting to swell. Used Epi pen #1 . I did not get better. I felt even more on fire and my skin was hot to the touch. My tongue was really swollen and things get super fuzzy after the I might die feeling. Epi#2 Given around 5 minutes after Epipen 1. Medics took me to the ER and more rescue meds were given. I was admitted to the nuero trauma floor for 24 hrs and given meds and iv fluids. I got out the next afternoon. By the next day I was back in urgent care. They gave me meds and sent me home. By 9pm that night I was using epi#3 and going back to the ambulance. I have been to urgent care 2 times since for continued issues. I have zero appetite and my whole GI system hates me. I am alive and breathing but still feeling the impact of all of this.
47 2021-04-14 platelet count decreased Patient admitted with massive portal vein thrombosis and low plt in setting of infection. Symptoms s... Read more
Patient admitted with massive portal vein thrombosis and low plt in setting of infection. Symptoms started one week prior
47 2021-04-18 pulmonary embolism, blood clot, deep vein blood clot Blood Clots; Pulmonary Embolisms; DVT (Deep vein thrombosis); This is a spontaneous report from a co... Read more
Blood Clots; Pulmonary Embolisms; DVT (Deep vein thrombosis); This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: ENG207), dose 2 via an unspecified route of administration, administered in Arm Left on 25Mar2021 10:00 (at the age of 47years) as single dose for Covid-19 immunization. The patient received the dose 1 of BNT162B2 via an unspecified route of administration, administered in Arm Left on 04Mar2021 08:30 (Batch/Lot Number: ENG203) as single dose for Covid-19 immunization. The patient is not pregnant at the time of vaccination. Medical history included essential tremor, insulin resistance, and anxiety; all from an unknown date and unknown if ongoing. Concomitant medications included propranolol, metformin, bupropion, and citalopram; all taken for an unspecified indication, start and stop date were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced blood clots, pulmonary embolisms, and a DVT (deep vein thrombosis) on 04Apr2021 (11:00AM). The patient was hospitalized due to the events for 4 days. The patient was treated with Heparin and Eliquis. The patient was tested for Covid-19 post vaccination via Nasal Swab on 03Apr2021 with Negative result. The outcome of events was recovering. The adverse events resulted in Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event).
47 2021-04-20 loss of consciousness, fainting positive COVID test; positive COVID test; felt dizzy and fainted; Blacked out several weeks ago whil... Read more
positive COVID test; positive COVID test; felt dizzy and fainted; Blacked out several weeks ago while going to bathroom; felt dizzy and fainted/light-headed; abnormal EKG; got head injury; Had a weird rash on elbows; headaches; concussion; sore throat; Started feeling more unwell several days ago; been fatigued for weeks; coughing with phlegm; mouth sores; laryngitis; muscle aches; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient (non-pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration, administered in right arm on 14Jan2021 at 08:30 at a single dose, second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982), via an unspecified route of administration, administered in right arm on 03Feb2021 at a single dose for COVID-19 immunisation at hospital. Medical history included known_allergies Penicillin, sulfur, NSAIDs. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. The patient received medications within 2 weeks of vaccination. Concomitant medications included gabapentin, trazodone, fluoxetine hydrochloride (PROZAC), oxymetazoline hydrochloride (CLARITIN ALLERGIC). Since the vaccination, patient has been tested for COVID-19. After second dose, but before patient left waiting area, on 17Mar2021, felt dizzy & fainted. Taken to ER. Had an abnormal EKG. Followed up with heart doctor. Blacked out several weeks ago while going to bathroom & got head injury. Husband and 2 sons tested positive for COVID mid March. Had a weird rash on elbows, been having headaches. Went to doctor about rash; not sure of cause. Told representative several times during contact updates for sons; representative said patient can't get COVID if she has been vaccinated. Went to doctor about head injury (diagnosed concussion on 17Mar2021. Supposed to see cardiologist and orthopedist for follow up but need to postpone due to positive COVID test on 17Mar2021. Started feeling more unwell several days ago; been fatigued for weeks. Symptoms included coughing with phlegm, headache, light-headed, mouth sores, sore throat, laryngitis, extreme fatigue, muscle aches. Positive rapid test 05Apr2021; PCR test on 05Apr2021; waiting for results. Treatment received for the adverse events. The outcome of the event positive COVID test was unknown and patient was recovering from all other events.
47 2021-04-24 hypotension, blood pressure increased, palpitations kidneys started hurting; UTI; heart pain; nausea; heart racing; blood pressure started going up; col... Read more
kidneys started hurting; UTI; heart pain; nausea; heart racing; blood pressure started going up; cold sweat; weak/did not have energy to talk; blood pressure was too low; This is spontaneous report from a contactable consumer reported for self. This 47-year-old female patient (not pregnant at the time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot#: ER8732) at single dose in left arm on 30Mar2021 01:45 PM for COVID-19 immunization. Medical history included nephrocalcinosis. Patient had allergies to contrast of iodine, had an anaphylaxis when they injected with iodine for checking her kidney, it was over 20 years ago. Concomitant medication included ethinylestradiol/ferrous fumarate/norethisterone acetate (LO LOESTRIN FE) for birth control. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 30Mar2021, with a minute taken the covid vaccine, patient started feeling nausea and heart racing. Her blood pressure started going up. The facility kept checking blood pressure and oxygen. After a bit, patient had no idea of time she felt a cold sweat and very weak. Patient did not have energy to talk. However, patient saw the nurse with an epi pen and she was able to tell that she was breathing. Doctor said that her blood pressure was too low. It had dropped to low 80. Patient kept trying to relax and suddenly it went all the way up again. Her normal blood pressure was 110/70 or 120/80 and it was 150/98. Patient started getting heart pain was taken to the ER and an ECG was made and her heart was ok. Her blood pressure stayed high. Patient kidney disease. Specifically, nephrocalcinosis; however, her kidney function still good. In the second day after the vaccine, on 31Mar2021, her kidneys started hurting and she felt like she was having an UTI (urinary tract infection) what she did not have had in the last year or so. All the adverse events result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Treatment received for all events was reported as unknown. The outcome of events was resolving.
47 2021-04-28 fainting faint; Dizziness; Nauseous; diarrhea; Tight throat; This is a spontaneous report from a contactable ... Read more
faint; Dizziness; Nauseous; diarrhea; Tight throat; This is a spontaneous report from a contactable consumer reporting for herself. A 47-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Apr2021 17:15 (lot number Ew0161) on left arm at single dose for COVID-19 immunization. Medical history included Meningitis. Concomitant medications included unspecified birth control medication. The patient experienced dizziness, faint, nauseous, diarrhea and tight throat, all on 14Apr2021 17:15. All events were resulted in Emergency Room Visit. No treatment was received for the events. Lab data included Blood Test on 22Dec2020 with unknown results. The outcome of the events were resolving.
48 2020-12-31 fainting, loss of consciousness Pt felt dizzy and nauseous after vaccine administration. When she tried to get up, she experienced s... Read more
Pt felt dizzy and nauseous after vaccine administration. When she tried to get up, she experienced syncope for about one minute. We administered Epi-pen and pt regain consciousness. Asked facility and patient if 911 call was needed, but patient refused. We monitored her blood pressure for over 1 hours and she stabilized at her baseline. We released her to go home and she will continue to monitor other potential adverse reactions.
48 2021-01-03 heart rate increased, chest pain Within a couple hours severe pain in left arm at injection site and deltoid; burning in left scapula... Read more
Within a couple hours severe pain in left arm at injection site and deltoid; burning in left scapula to left side of chest, by midnight was unable to lift arm away from body more than 25 degrees; burning in left scapula to left side of chest, by midnight was unable to lift arm away from body more than 25 degrees; Pain remains 7/10 in shoulder blade and arm; Still do not have full AROM 23+ hours after injection; muscle spasms around left shoulder blade 4-5 hours later; 130 resting heart rate 6 hours after; burning in left scapula to left side of chest, by midnight was unable to lift arm away from body more than 25 degrees/ Pain remains 7/10 in shoulder blade and arm; This is a spontaneous report from a contactable other healthcare professional (patient). A 48-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: Unknown), intramuscular in the left arm on 21Dec2020 13:15 at a single dose for COVID-19 immunization. Medical history included partial motor seizures face. Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medication included lisdexamfetamine mesilate (VYVANSE 40 mg), escitalopram oxalate (LEXAPRO 10 mg), brivaracetam (BRIVIACT, 100 mg). On 21Dec2020 4pm, within a couple hours severe pain in left arm at injection site and deltoid, muscle spasms around left shoulder blade 4-5 hours later, 130 resting heart rate 6 hours after, burning in left scapula to left side of chest, by midnight was unable to lift arm away from body more than 25 degrees. On 22Dec2020, by 9 am this morning back to 90 degrees shoulder flexion and abduction with pain. Pain remains 7/10 in shoulder blade and arm. Still do not have full AROM 23+ hours after injection. The patient was not hospitalized for the events and did not receive any treatment for the events. The events were reported as non-serious. The vaccine was administered in a workplace clinic. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered on an unspecified date in Dec2020 with sequel. Information regarding lot/batch number has been requested.
48 2021-01-03 palpitations, fast heart rate, heart rate irregular dizzy/feel faint; perspiring; like blood not getting to my head; had to get on hands and knees, craw... Read more
dizzy/feel faint; perspiring; like blood not getting to my head; had to get on hands and knees, crawl; felt like my heart may be racing 10 min after vaccine/heart felt off beat and like blood not getting to my head/heart rate was 142; felt like my heart may be racing 10 min after vaccine/heart felt off beat and like blood not getting to my head/heart rate was 142; arm sore day #1 and #2- not unexpected; This is a spontaneous report from a contactable Physician(patient). A 48-year-old female patient received first dose (BNT162B2, lot number EK5730) , intramuscular at Arm Right on 18Dec2020 14:15 at the 48-year-old at single dose for COVID-19 immunization. The medical history included elevated blood pressure , allergic to sulfa, hypertension and Covid. The concomitant products included alprazolam, diphenhydramine hydrochloride (BENADRYL), spironolactone, metoprolol for hypertension, colecalciferol (VITAMIN D 3). The patient previously took nubaine and experienced drug allergy. The patient also happened to be a physician in private practice and received the vaccine at her local hospital. The patient had hypertension which was under excellent control on metoprolol 25 mg. She took it as prescribed every day surrounding the vaccine. On day #1 at the vaccine she felt like her heart may be racing 10 min after vaccine was about 80 on 18Dec2020 14:25. nothing serious. The patient experienced arm sore day #1 and #2 and not unexpected. On about 7 pm the day after the vaccine 19Dec2020 she was tachy at rate of about 105. She took her metoprolol heart rate never came down. At about 9:30 pm on 19Dec2020 when her rate should have been about70- she got up from couch after falling asleep. Upon standing felt like she was very dizzy. Walked upstairs, started to feel faint, perspiring, heart felt off beat and like blood not getting to my head. She had to get on hands and knees, crawl and heart rate was 142 and sustained for almost a minute. It took over an hour for it to come back to 86 and stayed there all night. There was not treatment to all of the adverse events. The outcome of the events was Recovering.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the palpitations, tachycardia and other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including EKG, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
48 2021-01-03 hypertension employee getting Pfizer COVID19 vaccination. about 10 min post injection developed feeling of flush... Read more
employee getting Pfizer COVID19 vaccination. about 10 min post injection developed feeling of flushing and ?"prickliness" on skin. no resp distress no swelling or rash seen. VS taken and hypertension noted 170s/90s. normal O2sat and HR- NO prior medical hx of hypertension. Monitored for 30 min in vaccination clinic persistent hypertension. Referred to ED for ongoing monitoring-still hypertensive but eval neg referred to primary care provider for follow up
48 2021-01-04 chest discomfort 15 minutes after patient received her #1 Pfizer vaccine, she started to feel flushed with some throa... Read more
15 minutes after patient received her #1 Pfizer vaccine, she started to feel flushed with some throat irritation. She states she feels " a bit shaky inside ". Given juice and crackers. BP 143/84. heart rate 89. O2 sat 99%. She was moved into another quieter observation area. She claims she felt better. Given H20 to drink. States she had a bit of chest discomfort but this was nothing new to her. She has been having chest discomfort for the past 1-2 weeks periodically. Upon observing patient for 40 minutes, patient states, she felt better. BP 115/78, heart rate 80. Patient was then released. She states this is the first time this has happened while taking an IM injection.
48 2021-01-04 fast heart rate Anaphylaxis, Tachycardia, Lips numbness, tingling, Throat feels full, increased saliva Narrative: em... Read more
Anaphylaxis, Tachycardia, Lips numbness, tingling, Throat feels full, increased saliva Narrative: employee with an adverse reaction to the Covid vaccination. Reported to RN 10 minutes post vaccination Lips numbness/ tingling, throat fullness and slightly anxious. NP assessed employee and 50mg of IM Benadryl given in the opposite arm (right). No SOB or wheezing noted. VS pre treatment 158/99, 98%-RA, 98-HR, 18-RR. Ten minutes post treatment Lip tingling and throat fullness improving. At 20 minutes post treatment all S&S of adverse reaction resolved VS taken throughout even with 60 minutes of observation time total VS 139/84, 99%-RA, 81-HR, 14-RR. She is feeling tired and will consider calling for a ride to go home as advised by staff.
48 2021-01-04 blood pressure increased Chest and arms red and warm; metallic taste in mouth; no signs of distress when monitoring discontin... Read more
Chest and arms red and warm; metallic taste in mouth; no signs of distress when monitoring discontinued. Proceeded to PCP office the following day due to face, neck and arm stiffness, edema in hands, legs, and face, continued metallic taste, and elevated BP (160/100). PCP prescribed oral steroids, antihistamine, and Epi-Pen.
48 2021-01-04 heart rate irregular, palpitations Heart palpitations occurring 5-10 times a minute with sinus rhythm but irregular heart beat; Heart p... Read more
Heart palpitations occurring 5-10 times a minute with sinus rhythm but irregular heart beat; Heart palpitations occurring 5-10 times a minute with sinus rhythm but irregular heart beat; This is a spontaneous report from a contactable nurse (patient). A 48-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1284), via an unspecified route of administration on the left arm on 23Dec2020 09:00 at a single dose for COVID-19 immunization. The patient's medical history included allergies to dust mites, sinusitis, depression. The patient was not pregnant. Concomitant medications included fexofenadine hydrochloride (ALLEGRA), montelukast sodium (SINGULAIR), fluticasone propionate (FLONASE), and lamotrigine (LAMICTAL). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. On 24Dec2020 23:00, the patient experienced heart palpitations occurring 5-10 times a minute with sinus rhythm but irregular heart beat. There is no history of any cardiovascular diseases or abnormal findings. No caffeine or alcohol intake on the day of the occurrence. No treatment was received for the adverse events. Outcome of the irregular heart beat was not recovered while of the remaining event was recovered on 25Dec2020 23:00. The events were considered non-serious.
48 2021-01-04 chest discomfort, palpitations Post vaccine 12/18 Shoulder and upper/mid-back soreness pretty quickly; left arm feels stiff shortly... Read more
Post vaccine 12/18 Shoulder and upper/mid-back soreness pretty quickly; left arm feels stiff shortly after leaving observation area (32 min in observation) 9:30 lip tingling/ numbness, headache, back soreness/tightness/ pressure continues 9:40 hearing muted, fullness/mild pressure in ears - first left then right a little later Headache waxes and wanes - at times feels like vice squeezing my head 11:50 heartburn sensation 12:00 localized swelling/ knot at injection site 12:04 wave of nausea/ mild heartburn Headache continues off and on 3:30 ear ache, nausea, stiff joints, arm/shoulder/back pain, neck pain 16:00 dizzy/ nausea 16:22 flushed feeling in cheeks and neck; itchy cheeks, neck, chest 16:50 still flushed, itchy all over, heart palpitations. Fitbit shows HR 78 Hives for several hours. Hives gone by morning but still intermittently itchy. Eyes itchy/ feels like a contact lens is stuck in a wrong spot (have not worn contacts in 12+ years) Very mild cough started in evening 12/19 Hives in afternoon; itching off and on all day HR 91 (21:30) 21:43 HR 97 dizziness, headache 22:00 hives on face and abdomen 23:09 eye hurts again and is so itchy I want to rip it out of the socket, headache persists 12/20 Mild-to moderate itchiness upon waking, Itchiness off and an Mild headache off and on 9:15 heaviness in chest - feel I like do just before I get bronchitis, very mild cough Itchiness throughout the day. Hives on face in evening/Skin has a sunburn-type feeing Hives on neck and chest at bedtime Eyes itching then hurting - feels almost like pink eye type sensation As I was dozing off to sleep, heart palpitations - HR 97 12/21 Itchy/ hives on face, neck, upper chest By 12/21 afternoon, itchiness and hives abated. No further symptoms
48 2021-01-04 chest discomfort chest got tight; Shortness of breath; throat was itchy, and felt like it closed; throat was itchy, a... Read more
chest got tight; Shortness of breath; throat was itchy, and felt like it closed; throat was itchy, and felt like it closed; This is a spontaneous report from a contactable other health care professional (HCP) (also reported as respiratory therapist) from a Pfizer Sponsored Program. A 48-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EK5730), via an unspecified route of administration on 21Dec2020 at 48-years-old at a single dose for COVID-19 immunization. Medical history included asthma from 2000 and ongoing (diagnosed 20 year ago). There were no concomitant medications. On 21Dec2020, the patient experienced: chest got tight (non-serious), shortness of breath (non-serious), throat was itchy, and felt like it closed. The clinical course was reported as follows: The caller was a respiratory therapist (also reported as health care professional (HCP)). The patient's first dose of the vaccine was on 21Dec2020 at the hospital where she works. Five hours after getting the vaccine, her chest got tight, she has shortness of breath, her throat was itchy, and she felt like it closed. The patient had asthma (diagnosed 20 years ago) and felt this reaction. It took 48 hours after the initial symptoms that she felt better. For treatment, the patient took her salbutamol (ALBUTEROL) inhaler and diphenhydramine hydrochloride (BENADRYL). The patient was scared to have the second dose; and she was going to talk to her primary care physician (PCP) about the second dose (but she did not think she would have much knowledge on what to do). The patient had a COVID PCR test the day she received the vaccine, and it was negative. The patient underwent lab tests and procedures which included COVID-19 PCR test: negative on 21Dec2020. The clinical outcome of the events was recovered on an unspecified date.
48 2021-01-05 chest discomfort C/o lightheadness, nausea, chest tightness, sinus pressure, chest tightness, numbness and tingling i... Read more
C/o lightheadness, nausea, chest tightness, sinus pressure, chest tightness, numbness and tingling in nose, lips and mouth and eye lid swelling 12 hours after vaccine was given. Took Benadryl at 2230 and again at 12/29 0430. Called us to report s/s at 10:30 on 12/29. States symptoms are subsiding but still has eyelid swelling. Told to follow up with PCP.
48 2021-01-05 chest discomfort chest tightness, flushing, swollen lips, tingling in the left arm, no shortness or breath, no palpit... Read more
chest tightness, flushing, swollen lips, tingling in the left arm, no shortness or breath, no palpitations, no lightheadedness, no dizziness, no nausea or vomiting, no rash, no redness, no cough, no tongue swelling Started within 20-30 minutes of receiving the vaccine Received 25mg of Benadryl with improvement
48 2021-01-06 fast heart rate Headache, Myalgia, Rash, Hypoglycemia, subjective tachycardia (heart racing) Narrative: Within minu... Read more
Headache, Myalgia, Rash, Hypoglycemia, subjective tachycardia (heart racing) Narrative: Within minutes of vaccination, employee experienced sternocleidomastoid tenderness/tightness on the side of the vaccination with a feeling of her heart racing. She was transferred to the ED. Evaluation revealed mild rash, vital signs stable, normal oxygen saturation, no SOB, normal sinus rhythm on EKG. No evidence of pulmonary involvement, lung sounds clear. Assessment: Mild allergic reaction. After 5 hours of observation in the ED, patient experienced resolution of her subject tachycardia. She was treated for a headache with APAP during her stay, and reports improvement. She also had a mild hypoglycemia and was given ginger ale and graham crackers. Discharged to home.
48 2021-01-06 hypertension NauseaVomiting, HYPERtension, facial reddness to the chest. Went to the ER Narrative: Reports having... Read more
NauseaVomiting, HYPERtension, facial reddness to the chest. Went to the ER Narrative: Reports having facial redness to the chest. Had severe nausea and hypertension. Went to the ER and discharged later that day. Still having nausea today.
48 2021-01-06 chest pain Shortly after receiving the vaccine, the patient reported feeling flushed and hot with rash, shaking... Read more
Shortly after receiving the vaccine, the patient reported feeling flushed and hot with rash, shaking, shivering, and pain in upper chest, which the patient described as being normal because of her COVID pneumonia. I would rate the reaction as moderate. Diphenhydramine 25mg capsule was given by mouth, ice water was offered. Patient was closely monitored but no further intervention was necessary. After about 25 minutes, symptoms subsided and patient decided to leave.
48 2021-01-06 hypertension left hand numbness - resolved spontaneously followed by headache and HTN all resolved spontaneousl... Read more
left hand numbness - resolved spontaneously followed by headache and HTN all resolved spontaneously
48 2021-01-07 heart rate increased I started feeling achy (body aches) at night and took Tylenol and the next day at work I started hav... Read more
I started feeling achy (body aches) at night and took Tylenol and the next day at work I started having abd pain, joint pain and headache, and at home I checked my temp and it was 100.8F and my heart rate was fast, my lungs felt tight and a Tylenol and the symptoms continued for another day and gradually went away with exception of my joint pains. I also had tingling on my arms, back of my head, legs and my neck. I went to a neurologist and an allergist . My PCP does not want to make a decision about whether or not I should have the second dose before I see those.
48 2021-01-07 chest discomfort, fast heart rate Initial event was soreness at site which resolved on its own within a few days. 2 days after receiv... Read more
Initial event was soreness at site which resolved on its own within a few days. 2 days after receiving vaccine, I began having an allergy reaction to the same brand N95 that I had been utilizing since the beginning of the pandemic. Symptoms are swollen cheeks and welts , sudden itchiness at the site of my mask placement. The reason for this report is a sudden onset of excruciating and debilitating pain throughout my body specifically pain of my right shoulder radiating down my sprightly arm. I have been receiving testing and treatment for ongoing neuropathy due to Longhauler syndrome, however This recent pain is so debilitating, I spend most of my time in bed. I have been experiencing chills then profuse sweating. I also so fatigued, I sleep much of the day. I have been having episodes of tachycardia with chest tightness which has increased since after having the vaccine. I also become short winded on exertion. I?ve been waking up in a panic and sweating.
48 2021-01-07 palpitations Sxs heart palpitations on 12/28/2020 and then 12/29/2020 migrane headache. Sxs persist. Improved b... Read more
Sxs heart palpitations on 12/28/2020 and then 12/29/2020 migrane headache. Sxs persist. Improved but with occasional palpitations.
48 2021-01-07 blood pressure decreased about 7-8 mins after getting injection, I felt faint (put myself on floor because I knew I was going... Read more
about 7-8 mins after getting injection, I felt faint (put myself on floor because I knew I was going down if I didn't) cold clammy, nauseated, BP dropped, HR wnl, After about 20 mins, I felt fine. Went to work, did develop a migraine afterwards, some body ache and fatigue.
48 2021-01-07 hypertension, heart rate increased diarrhea; headache (HA); I felt light headed when I went to stand up and I was taken by wheelchair t... Read more
diarrhea; headache (HA); I felt light headed when I went to stand up and I was taken by wheelchair to the ED; my heart started racing; high blood pressure; Sinus tachycardia at 105 bpm; This is a spontaneous report from a contactable nurse. A 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot:EJ1685), via an unspecified route of administration on 28Dec2020 09:00 at a single dose for covid-19 immunization. The patient's medical history included allergy to fish but patient had a type of fish she was not allergic to on 01Jan2021. Concomitant medications were not reported. The patient received first vaccine on 28Dec2020 at 9:00 am. After about 5-15 minutes her heart started racing, she felt light headed when she went to stand up and patient was taken by wheelchair to the emergency department (ED). The procedures done in ED included Stat EKG which showed sinus tachycardia at 105 bpm and high blood pressure. Patient was normotensive normally. ED gave her Benedryl and pepcid. It took about 3 hours for my heartrate and BP to go back to normal in ED for 3 1/2 hours. Patient takes allergy meds everyday, allegra. The patient stated she went to bed and woke with headache (HA), (tylenol and ibuprofen were taken) lasted for 2 hours and returned the next day and patient took more ibuprofen and then it went away. The patient was allergic to fish, but she had a type of fish she was not allergic to on 01Jan2021 and had diarrhea within 30 minutes (one time occurrence). It was reported that the patient wishes to take the 2nd vaccine and has had no further adverse events. The outcome of the event was Headache (HA), heart rate increased and high blood pressure was recovered on an unknown date and unknown outcome for the remaining events.
48 2021-01-07 chest discomfort headache, muscle aches, chest tightness, lethargic, lightheaded for three days.
48 2021-01-07 fast heart rate tachycardia in 90s, 100s, and 110s x about 4 hours
48 2021-01-08 blood pressure increased, heart rate increased Elevated Heart Rate, Elevated Blood pressure (160/100), difficulty swallowing, blotching to chest an... Read more
Elevated Heart Rate, Elevated Blood pressure (160/100), difficulty swallowing, blotching to chest and neck
48 2021-01-08 blood pressure increased, heart rate increased Elevated Heart rate and blood pressure. Blotching to chest and neck. difficulty swallowing.
48 2021-01-08 palpitations Employee called Employee Health Dept 12/28/20 stating she felt tingling in her face and a flutter i... Read more
Employee called Employee Health Dept 12/28/20 stating she felt tingling in her face and a flutter in her chest shortly after vaccination done 12/22/20 (while being observed). States she informed staff, RNs in clinic state this employee did not report any reactions to clinic staff. Employee returned to work in ICU, states "felt better by end of day". 12/23/20 states swelling to both feet, reports 6+ (?) pitting edema. 12/24/20 states abdomen swollen. Called advice nurse who recommended she report to ED. Employee declined ED and took Benadryl instead. 12/26/20 states face swollen, joint pain, legs felt like they were on fire, could barely walk. 12/28/20 states feels better . Left foot a little swollen
48 2021-01-08 chest discomfort Short of breath, flushed, warm and cold shaky, a little hard to breath, little tight in the chest " ... Read more
Short of breath, flushed, warm and cold shaky, a little hard to breath, little tight in the chest " I have asthma too too hard to tell the difference" Tearful, skin felt clammy.
48 2021-01-08 chest discomfort, heart rate increased Within 10 minutes after vaccine, my face became extremely hot and red and left ear red and profuse s... Read more
Within 10 minutes after vaccine, my face became extremely hot and red and left ear red and profuse sweating. Within 30 minutes heart rate increased and a little clearing of throat. A little over an hour nausea started and increased clearing of throat , slight feel of constricture in throat and a slight feeling of heaviness in chest, and jittery and heart rate still feels increased. Nurse at Nursing home watched for 45minutes until I chose to leave. In my vehicle and home is when nausea started. Phone call contacts with nursing home staff continued for an hour. I took 2 benadryl and 2 Tylenol, napped. Felt better. Nausea 3 days. Tired and neck lymph achy.
48 2021-01-09 chest discomfort 1: 12/20/20: 4:30pm: headache, injection soreness, tiredness, feeling worn out: started around 8pm l... Read more
1: 12/20/20: 4:30pm: headache, injection soreness, tiredness, feeling worn out: started around 8pm lasting through next day 2: 1/9/21: 9am: headache, injection soreness, tiredness, feeling worn out, chills, body aches, chest tightness: started around 8pm lasting to next day (today)
48 2021-01-09 fast heart rate Within couple of minutes developed uneasiness, some tingling sensation, tachycardia and stomach quea... Read more
Within couple of minutes developed uneasiness, some tingling sensation, tachycardia and stomach queasiness. HR was 156, sats were 100 % on room air. Seemed to subside after 30 minutes . However throughout the rest of the day, waves of similar symptoms recurred predominantly tachycardia and GI along with skin sensitivity. Overnight did ok, but the following morning, again re urged with sustained tachycardia at which time sought ED evaluation. Had one episode in ED with HR in 151, other vital signs maintained. Received solumedrol and Benadryl. After treatment and monitoring without recurrence, discharged home on prednisone , Benadryl. Ativan if needed.
48 2021-01-10 loss of consciousness After vaccination, patient was ok, talking and eating. Suddenly, patient complains of dizziness, an... Read more
After vaccination, patient was ok, talking and eating. Suddenly, patient complains of dizziness, and "didn't feel right". Patient was laid flat on a couch, but then passed out and was not responsive to sternal rub. After a code was called, the patient woke up. At no time was there a loss of pulse or SOB. Patient was transported to the ER and was subsequently discharged same day. Patient did report that prior to the vaccination, she ran 13 miles in the morning, which may have had something to do with the reaction.
48 2021-01-10 fast heart rate I waited 15 minutes and was fine. As I was driving to my work, my injection site began to hurt sever... Read more
I waited 15 minutes and was fine. As I was driving to my work, my injection site began to hurt severely and I felt my throat swelling, it became increasingly difficult to swallow. My tongue felt larger and my lips and face began to feel numb. I felt flushed and I became tachycardic. It lasted about 45 seconds and then waned and then would flare again. I was able to speak and called my husband (a physician) who stayed on the phone with me while I drove to the hospital. I went straight to an outpatient unit and was given hydrocortisone IV, loratidine PO and famotidine. By the time I was on the unit, my throat only felt slightly tight with tachycardia down to 103. Following the injection of steroids, I only had one further flare of throat tightness and tachycardia that was transient lasting 30-40 seconds. Everything resolved within 40 minutes of receiving therapy. Of note, I apparently had erythema on the anterior of my neck which corresponded to the area of throat tightness.
48 2021-01-10 chest discomfort Patient is a healthcare worker who received the COVID-19 vaccine (Pfizer). Within 1 hour of vaccine... Read more
Patient is a healthcare worker who received the COVID-19 vaccine (Pfizer). Within 1 hour of vaccine, patient began experiencing nasal passage tightness, nasal congestion, and facial numbness. No wheezing, rash, visible swelling, tachycardia, or hypotensions. Given diphenhydramine, famotidine, and prednisone in emergency department. During observation in ED, started having throat and chest tightness with hyperventilation. This improved with lorazepam. Patient felt improved and was discharged with Epi pen and told to follow-up with her allergist.
48 2021-01-11 pallor I got the vaccine and had a headache that lasted 2-3 minutes. I then got in my car and I felt littl... Read more
I got the vaccine and had a headache that lasted 2-3 minutes. I then got in my car and I felt little bit sick and I picked up food and I started to feel sick. I went to work and my symptoms got worse and I sat in my desk and I felt like fainting. I just felt so sick and I thought it was my diabetes. A coworker saw me and told me i looked deathly pale and felt fainting and they took me to a ER room. They gave me Benadryl and IV fluids. I started seeing the floor and ceiling warped out, I was hallucinating. My legs felt numb as well. My eyes were twitching constantly. My blood pressure 147/95 and pulse was 112. I went home, ate and went to sleep. On Saturday I felt better and went back to work 12-28-2020, I felt weak and stayed working at my shift. On Tuesday I worked 1 hour and still felt super weak. Today I am starting to feel like myself again. I will not get my second dosage due to my symptoms I have experienced.
48 2021-01-11 chest pain Pt was given 2nd dose, monitored x 15 min with no complaint of symptoms of rxn. Left clinic, and sho... Read more
Pt was given 2nd dose, monitored x 15 min with no complaint of symptoms of rxn. Left clinic, and shortly after began having left-sided chest pain requiring ED visit approximately 5 hours after dose. Per ED notes, pt has hx HTN. Initial BP in ED 142/97. Dx is ED was CP r/o ACS. Pt was advised by ED MD to be admitted, however pt refused admission with a plan to f/u with her own cardiologist. Pt ultimately left AMA from the ED.
48 2021-01-12 chest discomfort Began to start having bulbar reaction with clearing of throat and tightness of chest; Began to start... Read more
Began to start having bulbar reaction with clearing of throat and tightness of chest; Began to start having bulbar reaction with clearing of throat and tightness of chest; Numb bottom lip progressed to both lips with swelling, then tip of tongue and progressed to tongue with numbing /swelling sensation; Numb bottom lip progressed to both lips with swelling, then tip of tongue and progressed to tongue with numbing /swelling sensation; Numb bottom lip progressed to both lips with swelling, then tip of tongue and progressed to tongue with numbing /swelling sensation; This is a spontaneous report from a contactable Other-HCP (patient herself). This 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL0142), via an unknown route, on 07Jan2021 at 14:15 at single dose for COVID-19 immunisation. Vaccine location was left arm. The patient was vaccinated at hospital, age at vaccination was 48-year-old. The patient was not pregnant. No other vaccine was received in four weeks.Relevant medical history included COVID 19 complications (prior to vaccination). The patient has allergy to contrast dye, sulfa and molds. Relevant concomitant medications included nebivolol hydrochloride (BYSTOLIC), topiramate (TOPAMAX), atorvastatin (LIPITOR), ascorbic acid, betacarotene, biotin, calcium, chromium, copper, folic acid, iodine, iron, lycopene, magnesium, manganese, nicotinamide, pantothenic acid, phytomenadione, pyridoxine hydrochloride, retinol, riboflavin, selenium, vitamin b1 nos, vitamin b12 nos, vitamin d nos, vitamin e nos, xantofyl, zinc (CENTRUM WOMEN), and acetylsalicylic acid (ASA). After vaccination, within 5 min she started with numb bottom lip progressed to both lips with swelling, then tip of tongue and progressed to tongue with numbing /swelling sensation. Began to start having bulbar reaction with clearing of throat and tightness of chest. She was given diphenhydramine hydrochloride (BENADRYL) total 50 mg, famotidine (PEPCID) 20 mg, dexamethasone (DECADRON) 4 mg and racemic epinephrine. The events required visit at emergency room/department and urgent care. However, the events were reported as non-serious by the reporter. Post-vaccination COVID test was not performed. The patient had not recovered from the events.; Sender's Comments: The reported "numb bottom lip progressed to both lips with swelling, then tip of tongue and progressed to tongue with numbing /swelling sensation", "bulbar reaction with clearing of throat and tightness of chest" developed within 5 min administration of BNT162B2, is likely an allergic reaction to BNT162B2, and considered related. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
48 2021-01-12 palpitations, chest discomfort Fever, body aches, uncontrolled chills, chest tightness, heart palpation, dizziness, lightheaded, vo... Read more
Fever, body aches, uncontrolled chills, chest tightness, heart palpation, dizziness, lightheaded, vomiting, mind splitting headsche
48 2021-01-12 chest pain Symptoms started mild after 14 hours after administration: body aches, after 22 hrs. I started to fe... Read more
Symptoms started mild after 14 hours after administration: body aches, after 22 hrs. I started to feel nauseous at first then I had chest pain, headache, chills, back pain, body aches (muscle pain) and dizziness
48 2021-01-12 blood pressure increased Systemic: Headache-Severe, Systemic: Nausea-Mild, Systemic: increasing blood pressure upwards of 170... Read more
Systemic: Headache-Severe, Systemic: Nausea-Mild, Systemic: increasing blood pressure upwards of 170/101 while lying down, heart rate 119, 100% o2 sat, difficult breathing. Patient was visibly nervous and apprehensive prior to receiving vaccine. ER via EMS. -Severe.
48 2021-01-12 blood pressure increased Systemic: Headache-Severe, Systemic: Nausea-Mild, Systemic: increasing blood pressure upwards of 170... Read more
Systemic: Headache-Severe, Systemic: Nausea-Mild, Systemic: increasing blood pressure upwards of 170/101 while lying down, heart rate 119, 100% o2 sat, difficult breathing. Patient was visibly nervous and apprehensive prior to receiving vaccine. ER via EMS.-Severe
48 2021-01-12 fainting Systemic: Nausea-Mild, Systemic: Vomiting-Mild, Systemic: Fainting-Mild
48 2021-01-13 blood pressure increased After she left the vaccine site she began feeling lightheaded. She was wheeled back to the clinic, g... Read more
After she left the vaccine site she began feeling lightheaded. She was wheeled back to the clinic, given a dose of epi, and IV fluids. Her BP was elevated. EMS was called and she was transported to the ED, released several hours later.
48 2021-01-13 haemoglobin decreased Dec 24 felt light headed and loss of appetite, Dec 25, fever 103 and chills, Dec 26 Team member Covi... Read more
Dec 24 felt light headed and loss of appetite, Dec 25, fever 103 and chills, Dec 26 Team member Covid hub had me do a Covid test, negative result, continue high fever, no appetite, chills and body ache, Health Hub contacted me daily with app to review symptoms, Dec 27-29 continued symptoms, unable to eat and little bit of water intake, Dec 29 appointment made with Health Urgent Care, received text from Urgent Care cancelling appointment and instructed to take sips of water and Tylenol that I was having an immune reaction to vaccine. Dec 29 virtual appointment with PCP continued symptoms, Dec 31 repeat of COVID swab along with Flu swab both negative, Jan 2-3 hospital admission for abnormal labs, jaundice, dehydration, Sodium/Potassium and Magnesium boluses given, and work up for infectious process was negative. Discharged to home Jan 3 with low grade fever, dry mouth, dry eyes, nausea, body ache and continued loss of appetite. Jan 4-7 continued worsening jaundice and appetite with low grade fever, GI Clinic consulted at Health Clinic, PCP in daily contact, repeat liver function labs on Jan 8 showed worsening labs. Jan 9-12 afebrile, started Ursodiol, low appetite better energy, continue dry mouth, GI appointment Jan 12 with plan to repeat liver functions on Jan 15, jaundice improved and able to eat liquids. No Tylenol or antipyretic taken since Jan 3 due to liver function tests.
48 2021-01-13 hypertension Employee is self-reported COVID "long hauler" with hx of HTN. Vaccine #1 given at 9:05am. Experience... Read more
Employee is self-reported COVID "long hauler" with hx of HTN. Vaccine #1 given at 9:05am. Experienced lightheadedness, nausea, bilateral hand tingling, hypertension after administration of her first COVID vaccination. No airway involvement. No rash, chest pain or SOB. Patient states that she thinks she had COVID in March though she tested negative. Patient has never had prior vaccine reaction. She was taken to ED, given PEPCID IV and liter of LR. Her vitals were stable throughout and she felt back to baseline and was released to go home after about 2 hrs.
48 2021-01-13 hypertension Immediate flushing followed by HTN and rash. Became dizzy and throat "tightness". Was surprised at... Read more
Immediate flushing followed by HTN and rash. Became dizzy and throat "tightness". Was surprised at the reaction since she is ex-military and had received a full complement of vaccine for overseas deployment with no issues.
48 2021-01-13 hypertension Patient was given the Covid 19 vaccine and was being monitored following vaccination. Within 15 minu... Read more
Patient was given the Covid 19 vaccine and was being monitored following vaccination. Within 15 minutes her upper lip started to swell and redness in the face. Blood pressure was monitored and was high ( around 230/110). Pulse ox was put on her finger. Oxygen levels were stable. Gave patient two benedryl tablets. No throat closing or trouble breathing. Patient went with wife to ER. From what I am told, patient given steroids in the hospital. She was released a few hours later and is at home now. Patient is currently stable at home.
48 2021-01-13 heart rate increased Reported heart rate of 108, a week of paresthesias. Symptoms resolved
48 2021-01-13 chest discomfort pressure in my chest/Chest discomfort; severe headache; nausea; chills; temp 102/fever; tingling of ... Read more
pressure in my chest/Chest discomfort; severe headache; nausea; chills; temp 102/fever; tingling of upper extremities/tingling; sore throat; shortness of breath; anxiety; malaise; This is a spontaneous report from a contactable Nurse (patient). A 48-years-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: EL1284), via an unspecified route of administration in left arm on 04Jan2021 05:15 at single dose for COVID-19 immunization. Medical history included the patient was diagnosed with COVID-19 prior to vaccination. The patient had no Known allergies. Concomitant medication included zinc, vitamin d3, quercetin and sambucus nigra (ELDERBERRY) received within 2 weeks of vaccination. The patient reported that 12 hours after the injection she experienced severe headache, nausea, chills, temp 102, tingling of upper extremities, sore throat, shortness of breath, pressure in her chest on 04Jan2021 17:15. The fever/chills lasted about 12hrs. Chest discomfort, tingling and shortness of breath were transient (possibly anxiety related). Day 2 post vaccine in Jan2021 moderate to severe HA (headache) persisted and malaise. The events resulted in Doctor or other healthcare professional office/clinic visit. No treatment received for the events. The events were reported as non-serious. The patient was not pregnant at the time of vaccination. The most recent COVID-19 vaccine was administered in hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was recovering.
48 2021-01-14 fast heart rate Uneasiness; tingling; tachycardia; Some abdominal queasiness; This is a spontaneous report from a co... Read more
Uneasiness; tingling; tachycardia; Some abdominal queasiness; This is a spontaneous report from a contactable Physician (Patient). A 48-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number: EK9231), via an unspecified route of administration on 07Jan2021 13:15 at single dose in Left arm for COVID-19 immunization. Medical history included hypothyroidism, breast cancer and severe local/regional reaction to bee sting. The patient previously took tamoxifen for breast cancer (9-10 years before 10Jan2021). There were no known allergies. Concomitant medications which the patient received within 2 weeks of vaccination included levothyroxine, tamoxifen. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced uneasiness, tingling followed by tachycardia within couple of minutes, some abdominal queasiness on 07Jan2021 13:15. Heart rate (HR) was 156. Seemed to subside over a period of 30 minutes. However slow waves of similar episodes occurred throughout the rest of the day, predominantly tachycardia and Gastrointestinal tract. Next day symptoms recurred and sustained a little longer. Sought evaluation. In Emergency department (ED), Labs unremarkable. One episode in ED with HR 151. Blood pressure (BP) maintained. Electrocardiogram (EKG) showed sinus tachycardia. Treated with steroids and Benadryl. On pulse dose steroids and Benadryl with overall improvement. The events resulted in Emergency room/department or urgent care. Treatments Solumedrol and Benadryl were received for the reported events. The outcome of the events was Recovering. This case reported as non-serious.
48 2021-01-16 heart rate increased Dizzy, weakness, tingling in lips and fingers, increased heart rate
48 2021-01-16 fast heart rate Feeling flushed, nauseated, hot flashes, lips tingling, tongue/throat swelling, SOB, leg weakness, t... Read more
Feeling flushed, nauseated, hot flashes, lips tingling, tongue/throat swelling, SOB, leg weakness, tachycardia.
48 2021-01-17 heart rate increased, palpitations, fast heart rate, oxygen saturation decreased Reporter received the Pfizer Covid-19 vaccine on Dec 28 around 7:55 am. That afternoon ~12:55, she s... Read more
Reporter received the Pfizer Covid-19 vaccine on Dec 28 around 7:55 am. That afternoon ~12:55, she started experiencing tachycardia. EMS was called to her home. She was evaluated and transported by car to the ER. EKG and labs were done (normal). It could not be determine if the vaccine was the cause. Dec 29th she went back to the ER for tachycardia and shortness of breath. Once again labs and EKG performed (normal). She had an appointment with a cardiologist that evening; a Holter monitor and an echo were ordered. She continued to have bouts of shortness of breath, tachycardia, muscle aches, and intermittent twitching. Went back to the ER Dec 31st
48 2021-01-17 chest pain The left side of my lip began to twitch, then my lips went completely tingly and numb, my face went ... Read more
The left side of my lip began to twitch, then my lips went completely tingly and numb, my face went numb, and I became a little bit disoriented while driving home. I also noted a pain in the left side of my chest. I got feeling back in my lips in my face approximately half an hour to 45 minutes later. I did take an Allegra allergy pill when I got home. I had already taken one Allegra allergy pill that morning. I slept for 12 hours on the following Friday night and Sunday night, whereas I typically only sleep approximately 6 to 7 hours per night. I noted significant stuffy nose and fatigue for the 3 to 4 days following the vaccine continuing until today.
48 2021-01-18 hypotension vomiting; chills; severe headache; stomach pain x72 hrs; severe nausea; dizziness; low blood pressur... Read more
vomiting; chills; severe headache; stomach pain x72 hrs; severe nausea; dizziness; low blood pressure; This is a spontaneous report from a contactable healthcare professional. A 48-year-old female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular from 05Jan2021 10:00 to 05Jan2021 10:00 at a single dose for COVID-19. Medical history included asthma, sibo, allergies to wheat, gluten, corn, tomato and peanuts. The patient's concomitant medications were not reported. It was reported that the patient's initial response to shot was severe nausea and dizziness, low blood pressure lasted 24hrs on 09Jan2021. 5 days later, the patient had nausea, vomiting, chills after meal, severe headache and stomach pain 72 hrs. The patient received IV fluids as treatment for all events. The patient underwent lab tests and procedures which included Covid Nasal Swab Test on 04Jan2021 which tested negative. The outcome of the events was not recovered. Information on the lot/batch number has been requested.
48 2021-01-19 hypertension just doesn't feel well; high blood pressure; feels like throwing up; This is a spontaneous report fr... Read more
just doesn't feel well; high blood pressure; feels like throwing up; This is a spontaneous report from a contactable consumer (patient) received via Medical Information Team. A 48-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced "having some high blood pressure", she "feels like throwing up" and "she doesn't feel well". The patient outcome of the events was unknown. The information on the batch number has been requested.
48 2021-01-20 fainting, fainting Employee received #2 COVID-19 vaccine 1/12/21 and slept through the night. When she was standing at... Read more
Employee received #2 COVID-19 vaccine 1/12/21 and slept through the night. When she was standing at the kitchen sink making breakfast at 10:00 am on 1/13/21 she fainted and woke up on the floor. Her child stated that she had fallen to the floor. She did not hit her head. This employee had an appointment to see her PCP the following day concerning something else. She did relay this information to her PCP who is asking that she follow up with a cardiologist. The PCP had no opinion if the vaccine may have caused her syncope. She currently has a appointment with a cardiologist.
48 2021-01-20 fast heart rate Fever 100.5; chills; joint pain; nausea; headache; tachycardia; shortness of breath; dizziness; pain... Read more
Fever 100.5; chills; joint pain; nausea; headache; tachycardia; shortness of breath; dizziness; pain & swelling at injection site and up my neck; pain & swelling at injection site and up my neck; worst patient have ever felt, felt like body had been poisoned; This is a spontaneous report from a contactable nurse (patient). A 48-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EJ1686 and expiry date: unknown), via an unspecified route of administration on the left arm on 09Jan2021 at a single dose for COVID-19 immunization. Medical history included heart disease, diabetes and allergies to sulfa antibiotics. Patient's concomitant medications were not reported. The patient received the first dose on 21Dec2020 (lot number: EH9899) on the left arm. The patient experienced fever 100.5, chills, joint pain, nausea, headache, tachycardia, shortness of breath, dizziness, chills, pain & swelling at injection site and up my neck, inability to lift even a water bottle without having pain on 10Jan2021. In summary it was the worst patient have ever felt, felt like body had been poisoned. Outcome of the events was recovering. No treatment was given for the events. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. No follow up attempts are possible. No further information is expected.
48 2021-01-20 chest discomfort Flushing accompanied by redness started about 25 minutes after shot while driving home. Chest heavin... Read more
Flushing accompanied by redness started about 25 minutes after shot while driving home. Chest heaviness without SOB or difficulty swallowing. Itching began starting with face then neck, chest and torso. Itching then spread to the whole body with a patina rash appearing on the face, neck and chest a few hours later. Immediately took dose of liquid Benedryl upon arriving home. Followed up by dose of Zyrtec. Continued monitoring sxs throughout the evening. Took additional 2 doses of Benedryl with a dose of Singular. Sxs severity lessoned though the night and into the next day. Mild itching and a few patches of the rash remained the next day 1/20/21. Continued taking antihistamine and allergy medication. All sxs have resolved as of 1/21/21
48 2021-01-20 chest discomfort Injection pain; headache; tiredness/feeling wornout; chills; body aches; chest tightness; This is a ... Read more
Injection pain; headache; tiredness/feeling wornout; chills; body aches; chest tightness; This is a spontaneous report from a contactable consumer. A 48-year-old female patient received the second dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL3249), via an unspecified route of administration in the left arm on 09Jan2021 at 09:00 at 48-years-old at a single dose for COVID-19 immunization. Medical history included Sulfonamide allergy, Factor V Leiden mutation, diabetes; all from an unknown date and unknown if ongoing. Concomitant medications included acetylsalicylic acid (BABY ASPIRIN), colecalciferol (VITAMIN D [COLECALCIFEROL]), lisinopril (MANUFACTURER UNKNOWN), vitamins nos (MULTIVITAMIN); all taken for an unspecified indication from an unspecified date to an unspecified date. The patient experienced the following events and outcomes: injection pain on 09Jan2021 20:00 with outcome of recovering , headache on 09Jan2021 20:00 with outcome of recovering, tiredness/feeling wornout on 09Jan2021 20:00 with outcome of unknown, chills on 09Jan2021 20:00 with outcome of recovering, body aches on 09Jan2021 20:00 with outcome of recovering, chest tightness on 09Jan2021 20:00 with outcome of recovering. The patient did not receive other vaccines in four weeks; there was no treatment for the adverse events; there was no prior COVID vaccination; there was no post vaccination COVID test.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021015284 same patient, different event and vaccine
48 2021-01-20 fainting, fainting Patient received #2 COVID-19 vaccine 1/12/21 and slept through the night. When she was standing at ... Read more
Patient received #2 COVID-19 vaccine 1/12/21 and slept through the night. When she was standing at the kitchen sink making breakfast at 10:00 am on 1/13/21 she fainted and woke up on the floor. Her child stated that she had fallen to the floor. She did not hit her head. Patient had an appointment to see her PCP the following day concerning something else. She did relay this information to her PCP who is asking that she follow up with a cardiologist. The PCP had no opinion if the vaccine may have caused her syncope. She currently has a appointment with a cardiologist.
48 2021-01-20 palpitations, chest pain palpitations, cp. no rash, no facial swelling.
48 2021-01-21 blood pressure decreased Extreme nausea, dizziness, decrease in blood pressure
48 2021-01-21 chest discomfort, palpitations Patient received her 1st COVID immunization and shortly after developed chest tightness/pressure, p... Read more
Patient received her 1st COVID immunization and shortly after developed chest tightness/pressure, palpitations, and lightheadedness. She reported a previous history of anaphylactic reaction to shell fish and IV dye.
48 2021-01-21 fast heart rate Started with a terrible headache the morning after vaccine. By the afternoon along with the headach... Read more
Started with a terrible headache the morning after vaccine. By the afternoon along with the headache, I had muscle aches. By 1am, I was having a low grade fever, chills, and tachycardia (120-130bpm).
48 2021-01-22 heart rate increased Fever100.5, body aches, chills, shaking, headache, rapid heart rate
48 2021-01-23 chest discomfort chest tightness, cough, runny nose, nausea, dizzy, red chest, high pitch voice, difficulty speaking.... Read more
chest tightness, cough, runny nose, nausea, dizzy, red chest, high pitch voice, difficulty speaking. anaphylaxis EKG monitoring, IVF, IM Epinephrine, IV Benadryl, IV Pepcid, Albuterol dual neb, CXR, Labs sent home after 6 1/2 hours of treatment and monitoring. Sent home with Epi pen
48 2021-01-24 blood pressure increased Increased blood pressure, light headed, nausea. Symptoms resolved in the ER and employee was able t... Read more
Increased blood pressure, light headed, nausea. Symptoms resolved in the ER and employee was able to return to full duty.
48 2021-01-24 pallor Sudden onset nausea, profuse sweating, pale, tingling hands and felt like would lose consciousness a... Read more
Sudden onset nausea, profuse sweating, pale, tingling hands and felt like would lose consciousness approx 1.25-1.5 hours after injection. around 12:10 pm or so. Removed excess clothing, put head between legs and turned on fan. Symptoms improved within 15 minutes. Headache later Saturday evening. Face hot and flushed and bad headache around 6pm Sunday evening. Face hot and flushed still Monday 1/25 in am but is getting a little better (I think) at the time of report.
48 2021-01-24 chest discomfort approximately 5 minutes after vaccine administration, reported headache and nausea. Brief chest dis... Read more
approximately 5 minutes after vaccine administration, reported headache and nausea. Brief chest discomfort. No respiratory symptoms, REsolved after 30 minutes and discharged to home.
48 2021-01-25 hypotension, hypertension My HBP rise up to 49 points 169/96, headache (not normal because i usually very healthy my normal B... Read more
My HBP rise up to 49 points 169/96, headache (not normal because i usually very healthy my normal BP runs usually 115/78 to 120/78)paramedic check me at 15min twice at that time. my tong was felt numb; i went home and took some Benadryl and a Tylenol for my headache , rise my legs up for about 1hr drink 3 water bottles and less than 1/2hr, my BP drop to 113/75 i went to bed felt very tired , next day, very tired my BP low 106/70 muscles achy, got diarea and nausea per one day, since then my BP keeps low, I have no energy, I call my dr. yesterday, he advised that I should be good by today; my BP keeps been in the lows, my back hurts, i have no energy; I need to call back my dr. by Thursday or Friday to see how am i doing;. he referral to ENT to check on my smell and test as follow up because i have covid back in june2020 and I'm having a hard time with it.
48 2021-01-25 blood pressure increased, heart rate increased Patient felt dizzy 15 minutes after receiving the Pfizer vaccine on 1/26. Her BP and pulse continued... Read more
Patient felt dizzy 15 minutes after receiving the Pfizer vaccine on 1/26. Her BP and pulse continued to elevated and she stated that she was short of breath. I contacted our rapid response team and she was transported to the ED for evaluation.
48 2021-01-25 blood pressure increased, heart rate increased Patient felt dizzy and cold within 15 minutes of receiving the vaccine. Her BP and pulse were eleva... Read more
Patient felt dizzy and cold within 15 minutes of receiving the vaccine. Her BP and pulse were elevated and she stated to feel short of breath. Rapid response team responded and the patient was taken to the ED for evaluation.
48 2021-01-25 chest discomfort Presents to Er c/o feeling like "I was falling" approx w/in 5 mins after receiving her second covid ... Read more
Presents to Er c/o feeling like "I was falling" approx w/in 5 mins after receiving her second covid vaccine. Slight substernal chest tightness w/ feeling like there is a lump in her throat. No sob/tongue swelling/nausea/vomiting or rash reported. Was given benadryl w/ mild relief.
48 2021-01-25 lightheadedness Sudden onset of nausea, vomiting, diarrhea, shortness of breath, uncontrolled shaking and vasovagal ... Read more
Sudden onset of nausea, vomiting, diarrhea, shortness of breath, uncontrolled shaking and vasovagal response with near syncope episode. Gave Diphenhydramine approximately 25 minutes after onset.
48 2021-01-25 blood pressure increased Symptoms: Lightheaded, elevated blood pressure. Treatment: Given water, monitored another 15 minutes... Read more
Symptoms: Lightheaded, elevated blood pressure. Treatment: Given water, monitored another 15 minutes. No further symptoms or treatment.
48 2021-01-25 fast heart rate, lightheadedness Within 3 hours of the event, started having expected side effects of headache, bodyaches. That night... Read more
Within 3 hours of the event, started having expected side effects of headache, bodyaches. That night had difficulty sleeping and new onset neck pain as well. Finally took tylenol at 3AM. Woke up at 9:15 and walked from bedroom to kitchen at which time had severe orthostatic hypotension with near sycope that did not progress to full syncope due to lying down quickly. Continued with tachycardia for several days and mild shortness of breath for two days. That evening, had new onset RUQ abdominal pain for 2-3 hours that resolved.
48 2021-01-25 chest pain Within a hour and a half my throat was on fire, and I called a virtual care through my insurance and... Read more
Within a hour and a half my throat was on fire, and I called a virtual care through my insurance and saw a provider via telehealth. She gave me Augmentin and prednisone. My sinuses were irritated. I had flu like symptoms but no fever. I was treated for strep throat. I have had mild throat burning since and have not fully recovered. I have had a severe headache ever since and have had to rotate Tylenol and ibuprofen everyday. I went into the ER 01/22/2021 with severe chest pain and they said I had GERD.
48 2021-01-25 palpitations neck was mildly swollen/mild superficial neck swelling; bounding pulse (palpitations); bounding puls... Read more
neck was mildly swollen/mild superficial neck swelling; bounding pulse (palpitations); bounding pulse (palpitations); This is a spontaneous report from a contactable consumer on behalf of herself. A 48-year-old female patient received her first BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE) Lot # EH9899, via an unspecified route of administration on 28Dec2020 at SINGLE DOSE at left upper arm for COVID-19 immunisation. There were no relevant medical histories or concomitant medications. The patient had a vaccination on 28Dec2020 and seven days later on 04Jan2021 her neck was mildly swollen and that same day it became more swollen and she had a bounding pulse also reported that had mild superficial neck swelling and a bounding pulse in her neck. The swelling has gone down, but got worse in the evening. The bounding pulse (palpitations) in her neck has improved but got worst at night, still occurred at night. No difficulty breathing and/or swallowing. She went to her physician on 05Jan2021 to find out why occurring. She was called to see if based off this symptom if she should have her second shot of vaccination. Followed up with her MD and had an Ultrasound (US) of her jugular in Jan2021 and all was normal. The outcome of the events was resolving.
48 2021-01-26 chest discomfort About 15 minutes after receiving the vaccine, patient reported some tightness in her chest. A few mi... Read more
About 15 minutes after receiving the vaccine, patient reported some tightness in her chest. A few minutes later, she had a dry cough. The facility doctor checked her out and said her vitals were good and her breathing sounded normal. She continued with the work day as normal.
48 2021-01-26 chest discomfort Chest tightness that started about 10 days after first dose. Lasted 4 days. Same symptoms started t... Read more
Chest tightness that started about 10 days after first dose. Lasted 4 days. Same symptoms started two days after the second dose. I have no cardiac history. Husband ( healthy marathon runner) also experienced chest tightness after the first dose but not his second dose. My father, who is 80 is also experiencing chest tightness after his first dose. He is scheduled for a stress test because he does have a cardiac history. I am a physician.
48 2021-01-26 heart attack, chest pain Left arm pain Hand pain left hand Numbmess from shoulder to hand left side Neck pain left side Chest... Read more
Left arm pain Hand pain left hand Numbmess from shoulder to hand left side Neck pain left side Chest pain left side Jaw pain left side Kidney pain left side Headache Was given Nitro pill and 3 1/2 baby aspirin by paramedics at testing site. Another Nitro pill in ambulance on the way to hospital. Treated for heart attack dueto Vaccine
48 2021-01-26 chest discomfort Pfizer-BioNTech COVID-19 Vaccine EUA Vertigo, low grade fever, fatigue started in afternoon 26 Jan ... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Vertigo, low grade fever, fatigue started in afternoon 26 Jan 2021 Vertigo all day, slight tightness in chest 27 Jan 21
48 2021-01-26 heart rate increased rash knot soreness fatigue headache itching fast heartrate body aches
48 2021-01-27 chest pain Left sided parietal, left temple down to auditory area, and left lower occipital region with pulsati... Read more
Left sided parietal, left temple down to auditory area, and left lower occipital region with pulsating and intense throbbing . The symptoms aggravates by bending and sudden movement . This had been worsening. The Pfizer first dose HA was brief at the same site. After the second dose of pfizer covid vaccine the above symptoms continues and intolerable. left sided piercing chest pain(CP) front through the back. This is different from CP I had. I was going to the hospital -i took my Imdur, ASA and benadryl - these relieved the symptoms
48 2021-01-28 heart rate increased, palpitations Rapid heart rate, heart palpitations, stomach pain?started 12 hours after vaccine.
48 2021-01-29 heart rate increased, chest pain Cough Throat tongue swell Dizzy Cold/ hot sweats Nausea Given 4 Benadryl immediately Numbness and... Read more
Cough Throat tongue swell Dizzy Cold/ hot sweats Nausea Given 4 Benadryl immediately Numbness and tingling in vaccine arm Went to ER for monitoring Ten minutes after started the worst headache of my life and I get migraines Have had pulse racing and slight chest pains all afternoon Went home after 4 hours observing Got a steroid through IV Fever has started after 12 hours
48 2021-01-29 chest discomfort, hypertension with dose 1given on 1/7/21 - within 5 mins -flushing, headache, chills, back pain., high blood press... Read more
with dose 1given on 1/7/21 - within 5 mins -flushing, headache, chills, back pain., high blood pressure in 150's, fatigue. Headache and backache lasted for 4 days. Fatigue for a week. I was monitored for 2 hours after injection. With dose 2 on 1/29/21- immediate - nausea, headache, lightheadedness, chest discomfort, very sleepy like I just wanna go to sleep right away. I was monitored for 2 hours until Chest discomfort subsided. nausea took more than 3.5 hours. headache is still on today the next day. Midnight -I had severe severe joint pains like my bones were ripping apart. very sleepy. i slept 12 hours straight. still have headache.
48 2021-01-30 chest pain, heart rate increased, palpitations Thursday- 25 minutes after injection I started tasting metal and my throat and chest got hot and sta... Read more
Thursday- 25 minutes after injection I started tasting metal and my throat and chest got hot and started to swell. It was a similar feeling to getting contrast through an IV. I took two Benadryl and Ibuprofen to help relieve the symptoms. The metal taste lasted until the next day. Friday- The next morning I woke if with a fever 100° . Minus the mild arm pain, I initially felt ok but as the day went on I felt worse, like the flu. By 11am my heart was racing even at rest. My pulse is usually in the low 60 range (athlete) and it was 95-115 from 11am until late that evening. Saturday- symptoms gone but huge dark circles under my eyes. I felt great though.
48 2021-01-31 palpitations, chest discomfort Chest pressure, heart racing, and feeling of breathlessness. Occurred after first one and passed ... Read more
Chest pressure, heart racing, and feeling of breathlessness. Occurred after first one and passed it off as anxiety but when it happened this time I was concerned it was side effect as not having any added stress or anxiety.
48 2021-01-31 chest discomfort Within 5 mins of vaccine I felt my chest tightening. I could still breathe but I could tell my lung... Read more
Within 5 mins of vaccine I felt my chest tightening. I could still breathe but I could tell my lungs were tight. Taking a deep breath was not normal. Soon after I felt the muscles between my shoulder blades starting to tighten as well. I think a response to my tightness in my chest. We were instructed to stay in facility for 15 mins. My symptoms did not increase after 15 mins so I went home. That was 5:00pm. By bedtime at 10:00pm my symptoms had resolved. I?m not sure if I should get my second dose?
48 2021-02-03 palpitations Increasing palpitations over the past two days along with some diarrhea and nausea
48 2021-02-03 palpitations Patient states she was waiting in post vaccination area when she began to become very anxious. Her h... Read more
Patient states she was waiting in post vaccination area when she began to become very anxious. Her heart was racing, felt hot, rash on chest, and felt throat feel thick. EMS was on site and took vital signs. Transported patient to Emergency Department via ambulance. Benedryl and Prednisone were administered IV. Patient was monitored for 4 hours at Emergency Department. Followed up with patient today. She is continuing to take Benedryl. Feels much better.
48 2021-02-03 lightheadedness, chest discomfort Right eyelid feels heavy; She slept all day Sunday; Extreme fatigue; Flushed feeling; lightheaded/di... Read more
Right eyelid feels heavy; She slept all day Sunday; Extreme fatigue; Flushed feeling; lightheaded/dizzy; lightheaded/dizzy like she was going to pass out; Had a heavy feeling in her throat and chest/Had a heavy feeling on her face- had removed her mask but it still felt like she still had it on; Had a heavy feeling in her chest; Tingling sensation on her lips; Tingling sensation on the right side of her face, and cheek; Severe burning in her right ear; Sore throat on the right side; When she was speaking it sounded like she had a thick tongue; Tongue feels swollen; Pain at the base of her skull on the right side; Pain on the right side of her forehead; Pinpoint pain that went down the right side of her spine; Metallic taste in her mouth; felt off; Pain at the injection site; It was so bad that it would wake her up if she rolled over; This is a spontaneous report from a contactable Nurse reporting for herself. A 48-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/lot number: EL3248), via an unspecified route of administration on 15Jan2021 at single dose (Once by injection in the right arm) for COVID-19 immunisation. The patient medical history was not reported. Historical vaccine included Hepatitis B vaccine. There were no concomitant medications. On 15Jan2021, after 15 minutes of monitoring she was fine. 5 minutes later or so (after 20 minutes), she had a flushed feeling and was lightheaded/dizzy like she was going to pass out. She returned to her office. She had someone check her blood pressure which was fine. It was 110/60. Normally it runs low in the 90s. Again, she thought she looked flushed. It was reported she had a heavy feeling in her throat and chest and on her face. She had removed her mask but it still felt like she still had it on. She had brought Benadryl with her, as she has had a reaction to the Hepatitis B vaccine before. She took the Benadryl since she felt off. She thinks this first part of what she experienced triggered everything else. By the time she got home, she had a tingling sensation on the right side of her face, on her lips and cheek. She had severe burning in her right ear. She also had a sore throat on the right side. Heaviness in her throat and chest- resolved late Saturday to early Sunday (Jan2021). Her husband noticed on Friday evening (15Jan2021) when she was speaking it sounded like she had a thick tongue. Saturday morning it was more normal. Her tongue does feels swollen. She also developed pain at the base of her skull on the right side. This started about 2 hours after the vaccine. She had pain on the right side of her forehead. She had pinpoint pain that went down the right side of her spine. She also developed a metallic taste in her mouth. She had pain at the injection site. It was so bad that it would wake her up if she rolled over. On 17Jan2021, she slept all day Sunday and also had extreme fatigue. On 18Jan2021, her right eyelid feels heavy on 18Jan2021. She does not think any of these are serious, but stated they are concerning. Vaccination card does not have the NDC or expiration date on it. Patient asked is getting the second dose of the injection recommend. She is leaning towards no but wanted to see what was recommended. She has reached out to her primary care about this. Outcome of the events flushed feeling, lightheaded/dizzy, lightheaded dizzy, like she was going to pass out was recovered on 15Jan2021. Outcome of the events when she was speaking it sounded like she had a thick tongue was recovered on 16Jan2021; Outcome of the events pain at the base of her skull on the right side, pain on the right side of her forehead, pinpoint pain that went down the right side of her spine, extreme fatigue, pain at the injection site was recovered on 17Jan2021; Outcome of the events Had a heavy feeling in her throat and chest/Had a heavy feeling on her face- had removed her mask but it still felt like she still had it on, and Had a heavy feeling in her chest was recovered on Jan2021. Outcome of the events severe burning in her right ear, sore throat on the ride side, tingling sensation on her lips, tingling sensation on the right side of her face and cheek was recovering. Outcome of the events tongue feels swollen, metallic taste in her mouth, right eyelid feels heavy was not recovered. Outcome of the events it was so bad that it would wake her up if she rolled over, she slept all day Sunday, and felt off was unknown. The reporter considered the events as non-serious. Causality assessment for events for felt off, she slept all day Sunday, It was so bad that it would wake her up if she rolled over was not reported. Causality assessment for all other events was reported as related.
48 2021-02-05 palpitations Felt racy heart, lightheadedness
48 2021-02-17 loss of consciousness pass out; vomiting; Severe muscle pains; Severe headache; This is a spontaneous report from a contac... Read more
pass out; vomiting; Severe muscle pains; Severe headache; This is a spontaneous report from a contactable Other HCP (patient). A 48-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 01Feb2021 at 10:00 at single dose in left arm for COVID-19 immunisation at the age of 48-year-old. Lot number was EL3248. Medical history included asthma, migraine headaches, thyroiditis. Concomitant medications included levothyroxine, fluoxetine, bupripion, clonazepam. The patient was not pregnant. Patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 10Jan2021 at 15:00 at single dose in right arm for COVID-19 immunisation at the age of 48-year-old. On 02Feb2021 at 23:00, the patient experienced severe vomiting which kept the patient up most of the night, she had to stay by toilet; the patient was feeling like she was going to pass out with any movement, the patient experienced severe muscle pains that felt almost like bones were breaking inside; the patient experienced severe headache; the patient almost took her-self to the emergency room in the middle of the night, but she did not want to expose her compromised immune system to others. The patient was not treated for the events. The patient was recovering from the events.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the LOC and other reported events due to temporal relationship Additional information is needed to better assess the case, including complete medical history, diagnostics including chemistry panel, Head CT/MRI and EKG, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
48 2021-02-21 fainting Patient admitted after syncopal episode, found subsequently to have a splenic artery aneurysm for wh... Read more
Patient admitted after syncopal episode, found subsequently to have a splenic artery aneurysm for which surgery not recommended. Pt was discharged on small-dose anxiolytic
48 2021-02-21 fainting patient was not vaccinated at hospital. Caregiver reports that patient was vaccinated with second d... Read more
patient was not vaccinated at hospital. Caregiver reports that patient was vaccinated with second dose on Monday 2/15/21. Tuesday patient experienced n/v/d. Went to an ED on Wednesday and was cleared and sent home. Thursday reported shortness of breath to her caregiver and then collapsed. Patient was brought to as PEA arrest and ultimately died.
48 2021-02-22 palpitations I received the first vaccine 1/11/2021 and the second dose on 02/03/2021. On 02/16/2021 my hair fe... Read more
I received the first vaccine 1/11/2021 and the second dose on 02/03/2021. On 02/16/2021 my hair fell out in clumps. I am post COVID and was Dx on 07/14/2020. I was discharged from the hospital on 09/17/2021. From my stay in the hospital on 07/14/2020 up until 02/15/2021 I had the minimum hair loss that one would loss in a day. I am not sure if the vaccines caused it , but my hair literally came out in clumps. I also started experiencing heart palpitations along with SOB in the evenings after the first vaccine. Upon the second week in February, I started experiencing the palpitations and SOB in the evenings. Again, I am not sure if the vaccines caused this as I am post COVID.
48 2021-02-23 heart rate increased -Common severe fatigue for roughly 36 hours -low grade fever resolved hour 40 -rash covering trunk f... Read more
-Common severe fatigue for roughly 36 hours -low grade fever resolved hour 40 -rash covering trunk front and back beginning at approx. hour 42, itchy and red -elevated HR noticed at hour 48 (100BPM)
48 2021-02-23 chest pain Drug Ineffective; felt like she had Covid plus the flu; very congested chest; Flu like symptoms; Che... Read more
Drug Ineffective; felt like she had Covid plus the flu; very congested chest; Flu like symptoms; Chest pain; Cough; Shortness of breath; This is a spontaneous report from a contactable consumer (patient). This 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), the first dose (Lot # EL1283) intramuscular at single dose in the right arm on 15Jan2021 and the second dose at single dose in the left arm on 03Feb2021 11:30, for covid-19 immunisation. Medical history included exposure to sars-cov-2 in Dec2020 (Her mother ended up positive for Covid and she was exposed to her and showed symptoms). There were no concomitant medications. On 03Feb2021, the patient experienced felt like she had Covid plus the flu with outcome of recovered on 05Feb2021, very congested chest with outcome of recovered on 06Feb2021, flu like symptoms with outcome of recovered on 05Feb2021, chest pain with outcome of recovered on 05Feb2021, cough with outcome of recovered on 06Feb2021, shortness of breath with outcome of recovered on 06Feb2021. The patient underwent lab tests and procedures which included oxygen saturation: normal on an unspecified date, sars-cov-2 antibody test: positive on an unspecified date. Therapeutic measures were taken as a result of felt like she had covid plus the flu, flu like symptoms. The events were described as follows: Patient said that she had some weird side effects from the 2nd vaccine, but not the first dose and believes that she had Covid in Dec2020. Patient said that she had flu like symptoms, she said it felt like she had Covid plus the flu. She said that she also had chest pain, a very congested chest, a cough, and shortness of breath. She did not have that with Covid. She said that her symptoms came on about 10 hours after the vaccination and were gone within 48 hours. Patient said that she does not know if having Covid so recently plays into it at all. Patient said that she received the last dose on 03Feb2021 at 1130. Patient said that the phlegm started in her throat and she had the chills. She woke up with the whole shebang. She stated that it got worse by the next day. She said that she did not feel a thing from the first injection and had no side effects. She never tested positive for Covid in Dec2020. Her mother ended up positive for Covid and she was exposed to her and showed symptoms. She had exhaustion vertigo, and general feeling of being unwell with Covid. She had all of that again, but she was told not to expect anything respiratory. She got concerned with the chest pain, cough, phlegm, and shortness of breath. She saw the doctor on 05Feb2021 and she was instructed not to take anything because it could affect the vaccine, but her symptoms went away within 48 hours. She said that she felt like the congestion felt like a allergic reaction for her, said that it was hard to swallow, and had a lot of phlegm in her throat. She said that it is not inherently different if you were allergic to flowers. Chest pain she described like you are full of phlegm and like there is inflammation. Shortness of breath: Feel panicky when you try to breath and you feel the phlegm. Patient said that when she gets sick she does have a tendency to get upper respiratory infections. Like with a cold that she would end up with a cough that would linger a little bit. She still thinks getting the vaccine was worth it. She just wished that it would have been a listed side effect, because when it is not, you panic. Most people are worried about the shortness of breath. She reported that her O2 levels were ok when she checked. Doctor gave her a vitamin IV to make her feel better. Told her that her lungs were clear and it was all upper respiratory.
48 2021-02-24 palpitations Patient received her first COVID vaccination today at 8:30 pm. Within 15 min of injection, she bega... Read more
Patient received her first COVID vaccination today at 8:30 pm. Within 15 min of injection, she began to look distressed and reported sensations of tingling in her elbows and behind her knees. No SOB, facial swelling, or heart palpitations. It was felt she may be nervous and she was given water and monitored closely. Vitals taken with O2 100%, HR 58, BP 134/89 Pt received Benedryl 25 mg when she began to note mild erythematous blotching on neck 10 min later vitals stable with bp 138/82 and pulse 62 Pt was given a second 25 mg dose to take if any symptoms worsened on way home- she was driving therefore I did not want to give her another dose at the time. She understands to call for emergency care if any SOB, facial swelling, or any distress Pt confirmed at 10 pm that she made it safely home with some improvement in her symptoms. I will follow up with her in the morning as well and will complete a VAERS report. I have educated her that at this time CDC would recommend not receiving the second vaccination, given potential allergic reaction within first 4 hours. We will review this again tomorrow I communicated with patient morning of 2/25/21- she states still mild tingling of arms but no new or worsening symptoms. She feels this is more consistent with anxiety and hesitant to not receive her second dose. I suggested she discuss with her primary care provider before her next visit and if she were to proceed with her second vaccination, I would suggest someone being with her to drive and she take 50 mg of benedryl 1 hr prior to vaccine. She was appreciative.
48 2021-02-24 hypertension Patient reported feeling flushed during observation period. Pt. gets anxious with shots and has chr... Read more
Patient reported feeling flushed during observation period. Pt. gets anxious with shots and has chronic HTN. Pt. was hypertensive. Pt. stated she felt better and was advised to go home and relax, check BP when rested, and check with primary care provider. If needs emergent attention go to nearest ER.
48 2021-02-25 palpitations Palpitations, rapid breathing, difficulty breathing, refused transport by EMS
48 2021-02-26 heart rate increased, hypertension Patient reported feeling anxious and warm after receiving the vaccine. Her heart rate was 130 at th... Read more
Patient reported feeling anxious and warm after receiving the vaccine. Her heart rate was 130 at the time. Subsequent readings: BP 160/110 O2 Sat 95% HR 119 BP 196/120 O2 Sat 96% HR 125 Patient was transported to the hospital.
48 2021-02-28 hypertension Developed high blood pressurein the days following the injection. Still being treated for it.
48 2021-03-04 chest pain A SHARP PAIN AND NUMBNESS IN INJECTED ARM IMMEDIATELY AFTER THE INJECTION, 25 MINUTES AFTER THE INJ... Read more
A SHARP PAIN AND NUMBNESS IN INJECTED ARM IMMEDIATELY AFTER THE INJECTION, 25 MINUTES AFTER THE INJECTION I EXPERIENCED A HEADACHE, CHEST PAIN, DIZZINESS, THROAT SWELLS UP AND IT'S HARD TO SWALLOW, AND BLURRY VISION.I TOOK SOME BENADRYL AND MY THROAT STOPPED CLOSING UP. I WENT HOME AND LAID DOWN. MY ARM IS STILL NUMB BUT THE PAIN HAS RECEDED. MY ARM ALWAYS SWELLS UP WHENEVER I RECEIVE AN INJECTION. 2 HOURS LATER THROAT IS STILL A LITTLE SWOLLEN, AND I HAVE A SLIGHT HEADACHE. CHEST STOPPED HURTING. LEFT ARM IS STILL NUMB.
48 2021-03-04 palpitations About 10 mins post vaccine my throat started to feel tight and almost numb.....then I was having dif... Read more
About 10 mins post vaccine my throat started to feel tight and almost numb.....then I was having difficulties swallowing, as if there was a lump in my throat......a few mins later my inner ears felt like they were burning and I felt pressure. I asked staff if symptoms were a side effect of vaccine at 15 minute mark from waiting period. They had me sit back down for another 15 mins and paramedic come see me. I told him I felt fine other than my throat feeling like it was as getting tighter and the difficulty swallowing. He offered to take my stats and I asked him to wait to see if symptoms would dissipate. After approx 49 mins of waiting from initial shot dose, my heart felt like it was racing and my throat felt tighter and I was now having a much harder time swallowing and I felt lightheaded. They took me back and hooked me up to get my vitals. About 7 mins later they brought an EPI Pen and I administered the shot in my leg. After approx 10mins +/- I began to feel my throat loosening a little. Then over the next 10 mins or so I felt almost normal with little trouble swallowing. They told me that I needed to go to the ER for further Eval. I arrived at ER approx 15 mins later and they gave me 2 Benadryl and 2 steroid pills and monitored me for the next 4 hrs - I was released shortly after - and again no other pain or side effects after EPI Pen and meds they administered. Sent home with EPI Pen and Steroids and instructions on what to watch for.
48 2021-03-04 chest discomfort Chest tightness
48 2021-03-08 chest pain, chest discomfort mild/partial loss of smell; headache; sinus discomfort (pressure, ache); Chest tightness/achiness; C... Read more
mild/partial loss of smell; headache; sinus discomfort (pressure, ache); Chest tightness/achiness; Chest tightness/achiness; This is a spontaneous report from a contactable healthcare professional reporting for herself. A 48-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EL-9261/expiration date: not provided), via intramuscular route of administration, on 30Jan2021 at 09:00 (at the age of 48 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. Relevant medical history was reported as none. The patient did not have any known allergies. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included vitamin D, cetirizine hydrochloride (ALLERTEC), and paracetamol (TYLENOL) (a few times after vaccine due to symptoms). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 02Feb2021 (also reported as "02Jan2021"), the patient experienced chest tightness/achiness. On 03Feb2021, (also reported as "03Jan2021"), the patient experienced mild/partial loss of smell, headache, and sinus discomfort (pressure, ache). The events required an emergency room visit/physician office visit. The patient did not receive any treatment for these events. The patient was assessed by ER on 02Feb2021: EKG, chest X-RAY and bloodwork looked good. It was assumed COVID due to recent exposure, however, 72 hour COVID test nasal swab PCR on 03Feb2021 and rapid test SARS Antigen FIA on 06Feb were negative. The patient had a post vaccination nasal swab, covid test name unsure - NOT rapid, covid test result pending. The outcome of the events chest tightness/achiness, mild/partial loss of smell, headache, and sinus discomfort (pressure, ache) was not recovered.
48 2021-03-10 blood pressure increased anaphylactic shock; BP 209/109 within 15 minutes of the shot/elevated BP; major headache; This is a ... Read more
anaphylactic shock; BP 209/109 within 15 minutes of the shot/elevated BP; major headache; This is a spontaneous report from a contactable other HCP. This other HCP reported for herself that a 48-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9265) at the age of 48-years, via an unspecified route of administration in left arm on 28Jan2021 10:30 at single dose for COVID-19 immunisation. Medical history included nerve damage; multiple surgeries from a wreck. Patient was not pregnant, was not pregnant at time of vaccination, there was no other vaccine in four weeks. No COVID-19 prior vaccination. Concomitant medications included duloxetine hydrochloride (CYMBALTA); loratadine (CLARITIN); colecalciferol (VITAMIN D); ascorbic acid (VITAMIN C); probiotics nos. The patient previously took rofecoxib (VIOXX), miconazole nitrate (MONISTAT), gabapentin, flu shot, all experienced allergies. At 10:45 AM on 28Jan2021, the patient experienced shortness of breath (SOB), BP 209/109 within 15 minutes of the shot, clammy, major headache. Received diphenhydramine hydrochloride (BENADRYL) on site and transferred by ambulance to hospital where she received Epishot, dexamethasone and ketorolac tromethamine (TORADOL). Diagnosed with anaphylactic shock. Went home with elevated BP and major headache. Daughter called an ambulance that night because the headaches were so bad. Ambulance driver stated they couldn't do anything for patient at the hospital unless she exhibited stroke like symptoms. BP stayed elevated for 2 days and headaches continued. Started to feel better 5 days later. Followed up with her PCP and patient was put on steroids for 5 days to taper down. The adverse events resulted in doctor or other HCP office/clinic visit, emergency room/department or urgent care. Patient received BENADRYL, epinephrine, dexamethasone, TORADOL as treatment for AEs. Lab data included: patient was tested negative for COVID-19 virus test (nasal swab) on 23Feb2021. Outcome of the events was recovered in Feb2021.; Sender's Comments: Based on the close temporal relationship, the association between the events anaphylactic shock, BP increased and headache with BNT162b2 use can not be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
48 2021-03-14 heart rate increased out of rhythm; heart rate increased; shortness of breath; impaired vision; some dizziness; Reported ... Read more
out of rhythm; heart rate increased; shortness of breath; impaired vision; some dizziness; Reported sleeping more heavily than usual; woke with her hair wet as if had experienced a fever overnight; anxious; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient started received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot# not provided), via an unspecified route of administration on 03Feb2021 at SINGLE DOSE for COVID-19 immunization. The patient has known allergies to sulfur and penicillin. Concomitant medications were not reported. The patient received first dose of vaccine on 03Feb2021. Immediately following injection, felt as if her heart rate increased; felt as if it remained out of rhythm through Thursday evening eventually returning to a more regular rhythm. She also experienced shortness of breath, impaired vision and some dizziness noted in Feb2021. She also been sleeping more heavily than usual woke with her hair wet as if had experienced a fever overnight. She stated she felt better, but still not at what she would consider her normal self and was anxious about receiving the second dose and wanted to speak with someone to further discuss her concerns. Outcome of anxious was unknown while recovering for the remaining events Information on the Lot/batch number has been requested.
48 2021-03-15 palpitations Numbness of nose & upper lip, shortness of breathe, anxiety, heart palps, coughing within 14 minutes... Read more
Numbness of nose & upper lip, shortness of breathe, anxiety, heart palps, coughing within 14 minutes of injections.
48 2021-03-22 loss of consciousness I passed out; This is a spontaneous report from a contactable consumer (patient). This 48-year-old f... Read more
I passed out; This is a spontaneous report from a contactable consumer (patient). This 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 Vaccine, lot Number: EL3248), via an unspecified route of administration, administered in arm left on 05Mar2021 11:00 am as a single dose for COVID-19 immunization. Medical history included hypertension (blood pressure). The patient is not a pregnant. Concomitant medications in two weeks included ashwagandha taken for an unspecified indication, start and stop date were not reported, and blood pressure meds (unspecified). There is no other vaccine received in four weeks. The patient passed out Sunday night, 07Mar2021 23:00, she's not sure if it was related to the vaccine. The AE resulted in: Doctor or other healthcare professional office/clinic visit. No Covid prior vaccination. No Covid tested post vaccination. Therapeutic measures were taken for the AE. The outcome of event was recovered on an unspecified date in Mar2021.
48 2021-03-24 blood pressure decreased, chest discomfort, heart rate increased, blood pressure increased, palpitations anaphylaxis; pounding of heart; tightness of chest; Itching; coughing; hives; swelling of throat and... Read more
anaphylaxis; pounding of heart; tightness of chest; Itching; coughing; hives; swelling of throat and ears; swelling of throat and ears; sudden drop in blood pressure; elevated blood pressure and heart rate; elevated blood pressure and heart rate; inability to breathe all within less than 30 minutes of injection during; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 17Mar2021 10:00 (Batch/Lot Number: EN6208) as single dose for covid-19 immunisation at a clinic. Medical history included asthma, allergies, and previous history of anaphylaxis to oral sulfa (Sulfa- anaphylaxis). Concomitant medications in two weeks included diphenhydramine hydrochloride (BENADRYL); clarithromycin (CLARTIN); levosalbutamol hydrochloride (XOPENEX); and fluticasone propionate (FLOVENT). There was no other vaccine in four weeks. On 17Mar2021 10:15, the patient experienced pounding of heart, tightness of chest, itching, coughing, hives, swelling of throat and ears, elevated blood pressure and heart rate, sudden drop in blood pressure, and inability to breathe all within less than 30 minutes of injection during observation. Epipen was administered on site and care team called 911. Ambulance arrived, assessed and informed her that she was experiencing anaphylaxis and took her to ER. ER gave her steroids and prescription for epipen and steroids. The next day itching, swollen throat, ears, pounding of heart and tightness of chest came back and she self injected epipen. Went to her doctor and was prescribed more epi pens, singular, Pepcid AC, and refilled her inhalers. She is to her seen again tomorrow by doctor. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, and were assessed by reporter as Life threatening illness (immediate risk of death from the event). Treatment for the events include Epipen, steroids, Pepcid AC, singular, inhalers. The outcome of the events was not recovered. The patient was not pregnant at the time of event onset or at the time of vaccination. Patient had no COVID prior vaccination and was not tested for COVID post vaccination.
48 2021-03-24 chest pain early stages of pericarditis or the shingles; severe chest pain; early stages of pericarditis or the... Read more
early stages of pericarditis or the shingles; severe chest pain; early stages of pericarditis or the shingles; This is a spontaneous report from a contactable healthcare professional (patient). A 48-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number: EL1283, unknown expiration), via an unspecified route of administration in left arm on 13Jan2021 at 13:00 (01:00 PM; at the age of 48 years old) at a single dose for COVID-19 immunisation. Medical history reported as none. There were no concomitant medications. The patient has no known allergies. The patient also received first dose of BNT162B2 (Brand: Pfizer; Lot number: EJ1685, unknown expiration) on 23Dec2020 at 01:00 PM in left arm (at the age of 48 years old) for COVID-19 immunization. The patient went to the ER with severe chest pain. After many tests were run, doctors believed that the patient was in early stages of pericarditis or the shingles on 17Feb2021 at 04:00 AM. The patient confirmed that she never developed shingles but have had all symptoms of pericarditis. The events resulted in emergency room/department or urgent care visit. The patient received NSAIDs and pain meds as treatment for the events. The patient had no COVID prior to vaccination and was not tested for COVID post vaccination. The patient did not receive other vaccine in four weeks. The patient is recovering from the events. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the available information, the Company considers the reported event pericarditis is unrelated to BNT162B2 vaccine, but more likely an inter-current medical condition. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
48 2021-03-30 palpitations EKG abnormality; Fell to the floor; Shortness of breath; Hyperventilating; Heart palpitations; Light... Read more
EKG abnormality; Fell to the floor; Shortness of breath; Hyperventilating; Heart palpitations; Lightheaded, Dizziness; Panic attacks; Severe anxiety; Nose numbness; Upper lip numb; Shaky feeling / Being on edge; Coughing; Depression; This is a spontaneous report from a contactable consumer (patient). A 48-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot Number: EN6199), via intramuscular route of administration in the left arm on 11Mar2021 at 15:47 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included ongoing osteoarthritis, ongoing fibromyalgia diagnosed about 15 years ago (2006) and ongoing anxiety diagnosed about 15 years ago (2006). The patient was very sensitive to medications even vitamins. The patient had a flu shot in Aug2020 (reported as Aug2021) and experienced chills that only lasted a day with the flu shot. The patient did not have any other vaccines within 4 weeks prior to the vaccination. There was no illness at the time of vaccination. Concomitant medications included nabumetone (manufacturer unknown) 2 doses a day, taken for an unspecified indication from an unspecified start date, then on 11Mar2021 at 09:00 at 2 doses a day and then on 12Mar2021 at 18:30 at 2 doses a day. On 11Mar2021, blood work and urinalysis were taken and the patient assumes they were normal. The patient reported that she received the first dose of the Pfizer vaccine last Thursday on 11Mar2021 at the pharmacy. She stated that this was the only thing that was new. On Thursday in the morning she was perfectly fine. Then she had lots of issues because of taking the vaccine. On 11Mar2021, shortly after she received the vaccine, within 14 minutes, her nose went numb, her upper lip went numb, she had shortness of breath, heart palpitations, panic attacks, severe anxiety, lightheaded / dizziness and the patient also experienced depression. Since the patient was very sensitive to medication and vitamins, at first she thought it could have been another medication, Nabumetone, an anti-inflammatory, but her physician said that it was not that because it was out of her system before she received the COVID vaccine. The patient said that she stopped the Nabumetone before the COVID injection. Her last dose before the vaccine was at 09:00 on Thursday (11Mar2021). She said that she usually takes 2 doses a day. She said that she took it again at 18:30 on 12Mar2021 Friday after the COVID injection. On 11Mar2021 at 17:00 she took alprazolam (XANAX) 1mg. She said that she ended up having a panic attack and could not breathe and stated that she thought she was dying. She kept coughing and her nose was numb. She took a Cetirizine (ZYRTEC) at 08:00 and it was not working fast enough so she took alprazolam 1mg at 08:15. She stated that she could not catch her breath and thought she was dying and she fell to the floor so her husband called the number. On 12Mar2021, Friday morning , she felt like she was dying. She was coughing and her nose was numb and she felt like she couldn't breath and she was pulling at her shirt and was lightheaded and dizzy. On 12Mar2021, Friday morning she was sent to the emergency room (ER) by ambulance because of the severe side effects. She had a hard time breathing. She contacted her physician via telehealth conference and was going to call them back to go in later this week. She said that she was still having anxiety. She was also still having shortness of breath, but it was more associated with anxiety now. She stated that because she had a panic attack she ended up hyperventilating and they thought her symptoms were from hyperventilating (which she has never experienced before). The patient inquired when the side effects will go away- referring to the heart palpitations, being on edge, and can't breathe. She stated that she was not all there due to her anxiety. Her biggest concern was the anxiety, it was a shaky feeling with heart palpitations. The patient spoke to her doctors and the pharmacists and both of her doctors advised her not to get the second dose of the vaccine. She asked the pharmacist if she should take Diphenhydramine (BENADRYL) and they told her no. On 15Mar2021, electrocardiogram (EKG) showed an abnormality and chest x-ray the patient assumes was clear. The outcome of events upper lip numbness was recovered on 12Mar2021 (Friday morning), nose numbness was recovered on 13Mar2021 (Saturday morning). The outcome of events heart palpitations, lightheaded / dizziness, severe anxiety, shaky feeling / being on edge, shortness of breath was not recovered. The outcome of event panic attacks, depression, hyperventilating, coughing, abnormal electrocardiogram and fall was unknown.
48 2021-04-07 cerebrovascular accident 03/24/2021 11:00 AM - PM sore throat - 03/25/2021 around 3:40PM had massive stroke while alone. 03/2... Read more
03/24/2021 11:00 AM - PM sore throat - 03/25/2021 around 3:40PM had massive stroke while alone. 03/26/2021 around 9:40AM broke window to get inside the apartment. Called ambulance, went to hospital, around 3:00PM transferred to other hospital and still there now. NO previous strokes Doctors have denied that the stroke is due to COVID 19 second vaccine. They also said that she will never be able to communicate but we have her on video. She has lying on her floor for 16 hours. The hospital also punctured her lung by inexperienced care givers trying to insert a feeding tube into her nostrils.
48 2021-04-07 cerebrovascular accident Stroke; This is a spontaneous report from a contactable pharmacist. A 48-year-old female patient rec... Read more
Stroke; This is a spontaneous report from a contactable pharmacist. A 48-year-old female patient received the second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 48-year-old, intramuscular, administered in right arm on 24Mar2021 13:00 (Lot Number: EL9262) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient was previously vaccinated with the first dose of BNT162B2 (lot number: EN6202) at the age of 48-year-old, on 03Mar2021 at 12:00 PM intramuscularly administered as the left arm for COVID-19 immunization. The patient experienced stroke on 25Mar2021 15:00. The event resulted in emergency room visit and the patient was hospitalized on an unspecified date for 6 days. It was unknown if treatment was given. The event was also reported as life-threatening and disabling/incapacitating. The outcome of the event not recovered.; Sender's Comments: A causal relationship between the event stroke and suspect product BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) is possible based on the information provided, drug profile and a temporal association in this 48-year-old female patient. This case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
48 2021-04-09 hypotension, palpitations 3 minutes - racing heart, then dry mouth 7 minutes dizziness and legs weak with low BP, 15 minutes h... Read more
3 minutes - racing heart, then dry mouth 7 minutes dizziness and legs weak with low BP, 15 minutes headache and photophobia, 12 hours worsening weakness moving into arms, following day diarrhea, blurred vision, by the 2nd day constipation dysuria, worsening ataxia by day 3, 1 week after unable to move R leg, admitted to hospital 4/1 and discharged next day. Readmitted 4/6 unable to move arms and move bowels/urine.
48 2021-04-09 loss of consciousness passed out; severe dizziness with nausea feeling; severe dizziness with nausea feeling; huge knot on... Read more
passed out; severe dizziness with nausea feeling; severe dizziness with nausea feeling; huge knot on head that is swollen and bruised; cut on my left side of neck; This is a spontaneous report from a contactable consumer (Patient). A 48-year-old female patient (non-pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EP7533), via an unspecified route of administration in left arm on 24Mar2021 at the age of 48 years old at a single dose for COVID-19 immunisation. Medical history included asthma controller, anxiety. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported. The patient previously took morphine and experienced allergy. Approximately 15hrs after receiving vaccine, On 25Mar2021 at 01:15, patient had severe dizziness with nausea feeling sat down and then passed out waking up after (unknown length of time) on the floor. Patient stated "i had struck my head and my left neck/shoulder on table and wall. Now I have huge knot on head that is swollen and bruised and a cut on my left side of neck." Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. The outcome of the events was not recovered. Follow-up Information has been requested.
48 2021-04-11 fainting, hypotension Recipient had a syncopal episode. Recipient was seen by on-site EMS - was bradycardic and hypotensiv... Read more
Recipient had a syncopal episode. Recipient was seen by on-site EMS - was bradycardic and hypotensive and had a 2nd syncopal episode. Patient was transferred to the hospital by ambulance for complete evaluation.
48 2021-04-15 oxygen saturation decreased, heart rate increased, blood pressure increased She felt like she couldn't breathe; Oxygen level was low; Adrenaline rush/Felt agitated; Heart was b... Read more
She felt like she couldn't breathe; Oxygen level was low; Adrenaline rush/Felt agitated; Heart was beating fast; Blood pressure was up; This is a spontaneous report from a contactable consumer (Patient herself). A 48-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: Unknown, Expiration date: Unknown) via unspecified route of administration in the right arm on 28Jan2021 13:20 as SINGLE DOSE for COVID-19 Immunization. The patients medical history included ongoing Hashimoto's disease (for about 20years), Breast cancer (had her five year clearance recently) and AFib (She had AFib two years ago because she was on too high of a dose) from an unknown date. Concomitant medications included ongoing Levothyroxine Sodium (Tirosint) at 175ug daily for hashimoto's disease and Liothyronine at 5ug daily for hashimoto's disease. Family history included her son had a reaction to a vaccine, but she is not sure which vaccine it was. His arm was swollen, red, hot, and painful after the vaccine. The patient has not tested for COVID-19 prior to vaccination and not since vaccination. The has not taken any Pfizer vaccine previously and not taken any other vaccine on the same day. The patient experienced adrenaline rush, heart was beating fast, blood pressure was up and felt agitated from 01Feb2021. She had the Pfizer vaccine on 28Jan2021 and four days later at work she felt like she had an adrenaline rush that lasted for 3 hours. It felt like her heart was beating fast, her blood pressure was up, and she felt agitated. It was unusual. It seemed to stop and she went to sleep at 20:00. She woke up at 22:00 and her heart was beating out of her chest and she felt like she couldn't breathe. Her Apple watch showed her heart was beating at 140 sitting still. She went to the hospital. It stopped after 45 minutes, maybe an hour. Her oxygen level was low when she got to the hospital. It was 92 and her blood pressure was up. She has just a higher level of agitation. She is not sure if that is the immune system. She snapped at someone at work and she has never done that. Her heart rate and blood pressure have resolved completely. The agitation is still there. She went to the ER on 02Feb2021. It resolved in the ER, so she was not admitted. She had no more racing heart that day. Her blood pressure was up in the ER. The agitation comes and goes. She gets that way when her adrenaline is going, if her blood pressure is up, or if she takes a steroid. Any kind of adrenaline reaction. She hasn't used them for so long. She did not reacting well to it. They checked her thyroid level. She had AFib two years ago because she was on too high of a dose. She was on the same brand of Tirosint, but higher dose. The dose may have been 200mg but she is not sure. She is not absolutely sure what dose she was on at that point. She wasn't on Liothyronine at that time. The patient visited the emergency room as she thought she was having a heart attack. It scared her. she is going to talk to her cardiologist to make sure it is ok for the second dose. The outcome of the events heart was beating fast and Blood pressure was up recovered, the outcome of other events was unknown. Information on the lot/batch number has been requested.
48 2021-04-15 blood pressure increased Tremors shaking hot cold sweats elevated blood pressure fatigue confusion blurred vision couldn?t qu... Read more
Tremors shaking hot cold sweats elevated blood pressure fatigue confusion blurred vision couldn?t quench my thirst dry mouth unsteadiness
48 2021-04-16 loss of consciousness Patient reported severe headache on 2/12/21 at approximately 3:30 pm followed by vertigo, nausea, vo... Read more
Patient reported severe headache on 2/12/21 at approximately 3:30 pm followed by vertigo, nausea, vomiting. Patient became unconscious and EMS was called, found patient on floor and she was brought to ED where CT revealed intracranial hemorrhage. Patient was admitted and supportive care given. She had worsening status on 2/17/21 with pupillary reflexes no longer present and withdrawal of care was performed on 2/21/21. Patient expired on 2/22/21.
48 2021-04-16 blood pressure increased Rising blood pressures starting overnight 10Feb2021; Persistent headache as well; This is a spontane... Read more
Rising blood pressures starting overnight 10Feb2021; Persistent headache as well; This is a spontaneous report from a contactable physician, the patient. A 48-year-old female patient (non pregnant) received dose number 1 of BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, lot number: EL9264) via an unspecified route of administration on 09Feb2021 at 12:15 PM(at 48-year-old ) in left arm as a single dose for COVID-19 immunization. Medical history included Hypertension (well controlled prior) and glaucoma. Patient had known allergies of cephalosporins. Concomitant medications included Diovan, Biotin, Vitamin D, Magnesium and Glucosamine (within two weeks of vaccination). The patient did not receive any other vaccines within 4 weeks prior to vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. On 10Feb2021 at 03:00 AM, rising blood pressures started overnight that led to doubling of Diovan dose, then switch to a different agent, followed by ER visit on 13Feb2021 for BP 175/103 and another medication was added and experienced persistent headache as well. Both symptoms persist at this time. New medication for BP control were given, EKG and labs done. Outcome of the event was not recovered.; Sender's Comments: A contributory role of vaccine BNT162B2 to the event rising blood pressures cannot be fully excluded based on the close temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
48 2021-04-17 deep vein blood clot, blood clot Blood clot DVT in left leg.; Blood clot DVT in left leg.; This is a spontaneous report from a contac... Read more
Blood clot DVT in left leg.; Blood clot DVT in left leg.; This is a spontaneous report from a contactable consumer. A 48-year-old non -pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), at the age of 48 years, via an unspecified route of administration, administered in the left arm on 01Apr2021 10:45 (Batch/Lot number was not reported) as a single dose for covid-19 immunization. The patient has no medical history. Patient has not had Covid prior to vaccination. The patient has no known allergies. The patient's concomitant medications were not reported. The patient experienced blood clot DVT in left leg on 02Apr2021 at 09:00. Treatment for the event includes blood thinners. It was reported that the AE resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event). The patient underwent lab tests and procedures which included nasal swab for covid test on 02Apr2021 which had a negative result. The outcome of the event was not recovered. Information about Lot/batch number is requested.
48 2021-04-17 fainting Fainted; Fever 101.6; Vomiting; Nausea; Dizzy; This is a spontaneous report from a contactable consu... Read more
Fainted; Fever 101.6; Vomiting; Nausea; Dizzy; This is a spontaneous report from a contactable consumer reporting for herself. A 48-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EN 9581/expiration date: not provided), via an unspecified route of administration, on 31Mar2021 at 10:45 (at the age of 48 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. Relevant medical history included lupus, scleroderma, Mixed connective tissue disease (MCTD), and high blood pressure (HBP). The patient did not have any known allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included hydroxychloroquine 200 mg, and losartan 50mg. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 31Mar2021 at 19:00, the patient experienced fainted, fever 101.6, vomiting, nausea and dizzy. The patient did not receive any treatment for these events. The outcome of the events fainted, fever 101.6, vomiting, nausea and dizzy was unknown. Since the vaccination, the patient had not been tested for COVID-19.
48 2021-04-20 excessive bleeding, loss of consciousness became faint and passed out onto the floor; hit my chin and jaw so hard it was bleeding; hit my chin... Read more
became faint and passed out onto the floor; hit my chin and jaw so hard it was bleeding; hit my chin and jaw so hard it was bleeding and obviously very sore and swollen; hit my chin and jaw so hard it was bleeding and obviously very sore and swollen; nauseous; light headed; chills; flu like symptoms; arm felt sore/arm at site of injection remains sore; at site of injection remains sore and itchy; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received BNT162B2 (lot number: ER8733) first dose on 30Mar2021 12:30 PM on left arm at single dose for COVID-19 immunisation. Medical history included IDDM (Type 1 diabetes mellitus) and MS (Multiple sclerosis). Patient is not pregnant. No other vaccine in four weeks. No known allergies. Concomitant medications in two weeks included Insulin for IDDM, dimethyl fumarate (TECFIDERA) for MS. Had vaccine at 12:30pm. At 3am (31Mar2021), arm felt sore and felt both nauseous and light headed as well as having chills and flu like symptoms. Went to bathroom and on way back to bed, became faint and passed out onto the floor. Patient hit chin and jaw so hard it was bleeding and obviously very sore and swollen. It's been nearly a week since that incident and arm at site of injection remains sore and itchy. She still feel nauseous at times and her face is still swollen from falling onto the floor and passing out. She was now fearful of having the second dose on 20Apr2021 as due since her reaction to 1st dose was so severe. The outcome of the events was recovering. No treatment for the events. No Covid tested post vaccination.
48 2021-04-24 heart rate increased Throat got tight; cholesterol is off and thyroid; thyroid function test: off; minor anaphylactic sho... Read more
Throat got tight; cholesterol is off and thyroid; thyroid function test: off; minor anaphylactic shock; discomfort throat; her heart rate accelerated; flushed face; unsteady; pain; This spontaneous report from contactable consumer (patient) via a Pfizer-sponsored program. A 48-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EJ6202), first dose via an unspecified route of administration, administered in left arm on 28Feb2021 10:40 (at the age of 48-year-old) as SINGLE DOSE for covid-19 immunization. Patient was 48 years old at the time of vaccination. Medical history included partial thyroid removal allergies to iodine, shellfish and bees, she also stated that she saw an endocrinologist who put on thyroid regimen of two different medications and she had a reaction, hives and that regimen had to be discontinued. No Prior Vaccinations within 4 weeks. Concomitant medications included levothyroxine sodium (SYNTHROID) 0.1mg tablet orally once per day in the morning been taking for at least four-fives years and epinephrine (EPIPEN). On 28Feb2021 the patient had small reaction, minor anaphylactic shock, discomfort throat, her heart rate accelerated, flushed face, pain and the patient was unsteady. The patient also stated that her throat got tight Epi Pen was not administered. Clinical course of the events includes, the patient stated that, after she received the vaccine she was instructed to stay 30 minutes instead of the 15 because she was sensitive to stuff and within about 5 minutes she started feeling discomfort in her throat. and was given Benadryl, when she has anaphylactic reactions her body goes in shock. By an hour later the heart acceleration, flush, and feeling unsteady these were completely gone. Benadryl knocked her out and she went to sleep for like 4 hours, woke up and her body was just hurting, but that only lasted a couple of days. She experienced pain for two days after. Had went for 2nd dose and facility denied her due to last reaction. Has been over 3 weeks and wants to know if there is an alternative for 2nd dose of vaccine. The patient underwent lab tests and procedures which included blood cholesterol: off, heart rate: accelerated, thyroid function test: off, all on unspecified date. Outcome of the events discomfort throat, body was just hurting was recovered. Outcome of rest of the events throat anaphylaxis, flushed face got tight, heart rate increased, unsteadiness, cholesterol low, thyroid hormones decreased was unknown.
48 2021-04-28 deep vein blood clot Developed a blood clot in peroneal vein of left leg.; This is a spontaneous report from a contactabl... Read more
Developed a blood clot in peroneal vein of left leg.; This is a spontaneous report from a contactable consumer. A 48-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ER8732), via an unspecified route of administration, administered on the right arm, at the age of 48 years, on Mar2021 at a SINGLE DOSE for covid-19 immunisation. Medical history included drug hypersensitivity to Penicillin from an unknown date and unknown if ongoing. Concomitant medications included vitamin b complex (VITAMIN B); astragalus mongholicus (ASTRAGALUS 6000); lysine (LYSINE) and multivitamins; all taken for an unspecified indication, start and stop date were not reported. The patient developed a blood clot in peroneal vein of left leg on 02Apr2021 06:00. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 07Apr2021. Therapeutic measures (blood thinners) were taken as a result of developed a blood clot in peroneal vein of left leg. The outcome of the event was recovered with sequelae.
49 2021-01-03 chest discomfort Patient is a 49 y.o. female with a PMHx of AAT deficiency, HPV infection, DVT, Vitamin D Deficiency,... Read more
Patient is a 49 y.o. female with a PMHx of AAT deficiency, HPV infection, DVT, Vitamin D Deficiency, Hypercholesterolemia and Anxiety with complaints of acute left arm numbness that radiates into her left digits and chest tightness that began 12-13 min after receipt of the COVID-19 vaccine. She noted numbness radiation into the left side of the neck and the bilateral ears. She voices she has also developed chest tightness and wheezing. Evaluated in the emergency department treated with diphenhydramine 25mg, epinephrine 0.3mg and dexamethasone 10mg
49 2021-01-03 fast heart rate Tachycardia and flushing immediately after shot given, followed by fullness (slight swelling) in mou... Read more
Tachycardia and flushing immediately after shot given, followed by fullness (slight swelling) in mouth, prickly feeling to tongue.
49 2021-01-04 chest pain I had left chest wall pain (lateral) while breathing and laughing. I don't believe it was muscular... Read more
I had left chest wall pain (lateral) while breathing and laughing. I don't believe it was muscular.
49 2021-01-04 palpitations I experienced my heart racing as I was driving back to my clinic. This happened about 45 minutes af... Read more
I experienced my heart racing as I was driving back to my clinic. This happened about 45 minutes after getting the vaccine. Twice while I drove back to work and twice while I was working. These episodes were brief. I also experienced numbness and tingling in my arm that received the injection. This feeling spread to my shoulder and traveled up my neck to my face. I had numbness and tingling on my left side of my face and lower lip. This lasted till about 3:30 pm and then went away. Tonight around 7:00 pm I am still experiencing some numbness and tingling on my face and lip which comes and goes. I am having soreness in my arm at the injection site.
49 2021-01-05 heart rate increased Eyes were red; Tiredness and needed to sleep extra; Tiredness and needed to sleep extra; Heartbeat w... Read more
Eyes were red; Tiredness and needed to sleep extra; Tiredness and needed to sleep extra; Heartbeat was fast; Felt like she had to throw up; Pain in right arm; Does not feel good; It felt like there was oil in her mouth; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received first dose of BNT162B2 via an unspecified route of administration on 30Dec2020 10:45 at single dose in right arm for COVID-19 immunization. The vaccination was given in hospital, not a military facility, at 10:45 and left hospital at 11:05 on 30Dec2020. Prior vaccinations within 4 weeks was none. Additional vaccines administered on same date of the Pfizer suspect was none. Medical history included ongoing migraine and family medical history included mother has high blood pressure and father has diabetes. Concomitant medication included verapamil from Oct2020 at 40 mg twice daily by mouth for migraine. Additional Information for concomitant products Verapamil included 1 for one week, 2 for second week 3rd week 3 and after 3 months, then came back down to 2. The patient experienced does not feel good at 11:30 on 30Dec2020. She was driving and did not feel good. She felt like she had to throw up at12:00 on 30Dec2020 and had it all night until she went to bed. Eyes were red when she woke up at 23:30 on 30Dec2020, that's when she first noticed. Heartbeat was fast around 12:30 on 30Dec2020. Tiredness and needed to sleep extra at 17:00 on 30Dec2020. Pain in right arm at 12:00 on 30Dec2020. When she went to drink something, she noticed her arm was painful. No ER or physician's office required. Received call from patient regarding the COVID vaccine. She received it on 30Dec2020 (yesterday) and was a healthcare worker. She later stated she works in patient transportation in a hospital. She did not feel good. Yesterday, she felt like she had to throw up. When she slept, she felt very tired and when she woke up, her eyes were red. She washed her face when she woke up around 11. Then she noticed her heart beat was kind of fast. She took another medication she takes all the time. Her doctor said that she can take it with it but she was not sure. She did not feel herself. Yesterday after she took it, she had to wait there for 15 minutes. It felt like there was oil in her mouth. She just drank water and came home. When she came home, her heart beat was fast. She had to sit down. She liked to eat spicy food, and she needed to sleep. Her kids said she never slept like this. Both eyes were red, red like blood. Her daughter told her to go look at them in the mirror. There was no pain or nothing in her eyes, they were just red and they improved today. If she goes to bed now, she can sleep, but she just wakes up and drinks tea and wants to wake up. She didn't want to sleep, but she felt like she could. Regarding the pain in her right arm, she had to hold her shoulder when she first woke up. It was worse then, but it's better now that she keeps moving it. She has 3 more weeks to get the next dose of the COVID Vaccine. Hopefully it will be this shot only and she can go back to work. She planned on going back to work on Saturday. She would like to know if she can continue to take Verapamil. She will call her pharmacy to find out. The outcome of the events does not feel good and tiredness and needed to sleep extra was not recovered. The outcome of the events felt like she had to throw up, eyes were red, heartbeat was fast and pain in right arm was recovering. The outcome of the other event was unknown. Information on Lot/Batch Number has been requested.
49 2021-01-05 blood pressure increased, palpitations I did let the nurse know right after I got the vaccine It did feel like a huge water balloon was si... Read more
I did let the nurse know right after I got the vaccine It did feel like a huge water balloon was sitting on my arm and very heavy at the site. I went to the waiting area and the last 5 minutes and I started feeling weird, kind of getting dizzy and my heart started racing really fast. Am I can tell I was getting really hot and my face was flushed and my heart was racing and my hands started shaking, trembling almost like I couldn't control it. I've never experienced something like this. The part that really scared me was my heart racing like it was going to come out of my chest. They called a code, put me in a wheel chair and took me to the ER (where I work). They took my blood pressure which was really high, they did EKG, blood work and urine test. They kept me there for about five hours, while watching me. And the last weird thing that happened at one point I felt like liquid was running thru my body and my feet were really cold for several hours, It felt like someone was pouring liquid over me. I kept asking the nurse if this is normal and no one knew what to tell me. After everything started slowing back down and it had been a couple hours and the next day i felt like I had a slight head ache and felt out of it, kind of like I had a hangover and of course my arm was really sore. The Doctor in the ER did advise me not to get the second dose as it will be worse than the first one.
49 2021-01-05 blood pressure increased Patient experienced dizziness, "brain fog", and elevated blood pressure 15 minutes post vaccine admi... Read more
Patient experienced dizziness, "brain fog", and elevated blood pressure 15 minutes post vaccine administration
49 2021-01-05 fainting bp 100/54 synocopalepisode; experienced nausea, was anxious prior to injection; states this has happ... Read more
bp 100/54 synocopalepisode; experienced nausea, was anxious prior to injection; states this has happened with another injection in past. is now awake, alert and oriented; 911 called-evaluated by ems; refused transport; observed an additional15 min. s/s resolved; denies sob, rash, edema, etc.
49 2021-01-05 heart rate increased, chest discomfort, hypertension coughing; Itching; chest tightening; large whelps all over body, face, eyes; high blood pressure and... Read more
coughing; Itching; chest tightening; large whelps all over body, face, eyes; high blood pressure and heart rate noted; high blood pressure and heart rate noted; 18 hrs after vaccine mild rash on back and arms and mild sob; 18 hrs after vaccine mild rash on back and arms and mild sob; This is a spontaneous report from a contactable nurse, the patient. A 49-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 9231), via an unspecified route of administration in the right arm on 23Dec2020 at 19:30 (at the age of 49-years-old) as a single dose for COVID-19 immunization. Medical history included asthma, kidney stones, and gastrooesophageal reflux disease. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ethynylestradiol/norgestrel (OGESTREL-28), cetirizine hydrochloride (ZYRTEC), and cefdinir (OMNICEF). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took nicotinic acid (NIACIN) on unknown dates for an unknown indication and experienced drug allergy in the form of mild flushing. On 24Dec2020 at 13:30, 18 hours after the vaccine, the patient experienced mild rash on back and arms and mild shortness of breath (SOB). On 25Dec2020, the next day, the patient had a severe rash with large whelps all over body, face, eyes. She had extreme SOB, chest tightening, coughing and itching. The patient went to the hospital emergency room and high blood pressure and heart rate were noted. On 25Dec2020, the patient had a nasal swab done for COVID and it was negative. The patient was treated for the events with IV methyprednisolone (MANUFACTURER UNKNOWN), IV famotidine (MANUFACTURER UNKNOWN) and hydroxyzine pamoate (VISTARIL). The clinical outcomes of the rash, SOB, large whelps, chest tightening, couching, itching, high blood pressure, and high heart rate, were recovered in Dec2020.
49 2021-01-05 blood pressure increased periorbital swelling ;swelling of lips tightening of lips ; BP elevated remained elevated more than... Read more
periorbital swelling ;swelling of lips tightening of lips ; BP elevated remained elevated more than 15mins Transported to Emergency Room for evaluation Received Benedryl 50 mg PO
49 2021-01-06 chest discomfort, chest pain About an hour after the injection I had pain and burning going down my left side and in the left sid... Read more
About an hour after the injection I had pain and burning going down my left side and in the left side of my chest that lasted about 45 min. I was fine for the next 12 hr. Around midnight I started with chills, joint pain body aches and a headache. I woke up around 2 am with a fever. All day on the 6th I felt horrible with body aches, joint pain and a severe headache. Around 10 pm on the 6th I started again with chills fever chest pain SOB Cough and vomiting (3 episodes throughout the night.) My lungs currently feel like they are on fire and I continue to have chest tightness, joint pain Severe headache and a cough. I am approximately 56 hr post second vaccination. I had no problems with the first vaccination
49 2021-01-06 fast heart rate Nausea, Headache, Weakness, Shortness of breathing, elevated heart rate, light-headed. Just felt bad... Read more
Nausea, Headache, Weakness, Shortness of breathing, elevated heart rate, light-headed. Just felt bad (Still having some of these problems)
49 2021-01-06 chest discomfort This was the vaccine recipient's 2nd vaccination. They had no issues with the 1st vaccination. Vacci... Read more
This was the vaccine recipient's 2nd vaccination. They had no issues with the 1st vaccination. Vaccine recipient reported that after 10 minutes of receiving the 2nd vaccine they developed a headache that felt like a migraine. The vaccine recipient took Advil, then a few minutes later started sweating, felt clammy, and hot. The symptoms started to pass 15 minutes later. That night they reported that their chest felt tight but it went away before bedtime. This morning 1/7/2021, vaccine recipient reported feeling tired and mind felt foggy. They were able to continue to go to work.
49 2021-01-06 blood pressure increased Today was my second dose of the COVID vaccine and just a few short minutes after the injection the i... Read more
Today was my second dose of the COVID vaccine and just a few short minutes after the injection the injection site start itching. At just about the 15 min wait time after ionjection a nurse asked if i was feeling ok. I told her i was feeling gine but my arm was very itchy. She checked the site and I had redness all around the site and welt size hives around the site. She asked me to stay 15 min longer and I agreed. Shortly after that the hive started to spread to my neck and chest area and I became lightheaded and faint feeling. I became very hot. They gave me and injection of benadryl and since my BP was high and my syptoms were not going away completly I was taken to the ER for monitoring and IV fluids. There I was given more Benadryl, steroids, Pepcid and IV fluids and monitored. I felt much better and was released to go home with a RX for 4 days of steroids.
49 2021-01-06 palpitations, fast heart rate a strong, whole body heat, and flushing; a strong, whole body heat; tachycardic; Palpitations; This ... Read more
a strong, whole body heat, and flushing; a strong, whole body heat; tachycardic; Palpitations; This is a spontaneous report from a contactable Nurse(patient). This Nurse reported for similar events for 6 patients. This is 1st of 6 reports. A 49-year-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28Dec2020 at the 49 years old at single dose for COVID-19 immunization. The medical history and concomitant medications were not reported. The registered nurse and 5 other registered nurses she worked with, had a serious reaction right after receiving the COVID-19 Vaccine. The patient had a weird reaction right after she was injected with the COVID-19 Vaccine. She had a strong, whole body heat, and flushing. She said she became tachycardic and had palpitations that lasted a few minutes. She said the tachycardia and palpitations then slowly resolved in less than 5 minutes. The patient said she had no other symptoms after receiving the COVID-19 Vaccine. The reporter said there were 5 other registered nurses that received the COVID-19 Vaccine at the same time and had the same exact symptoms she experienced. The reporter said stated the registered nurse who was monitoring the people who received the COVID-19 Vaccine indicated that the same feeling had occurred in many other workers who had received the COVID-19 vaccine. The reporter stated she did not know if the patient had received any other vaccines at the same time as the COVID-19 Vaccine, and if the patient had received any other vaccines within the last 4 weeks. The patient works at a hospital but didn't received any medical treatment. The patient just waited her symptoms out, and within 5 minutes her symptoms had gone away. The outcome of the events was recovered on 28Dec2020. Information on the lot/batch number has been requested.; Sender's Comments: A possible contributory role of the suspect products cannot be excluded for the reported events based on the known safety profile and temporal association. Case will be reevaluated based on follow-up information ,Linked Report(s) : US-PFIZER INC-2021001363 same reporter/drug/event, different patient.;US-PFIZER INC-2021001364 same reporter/drug/event, different patient.;US-PFIZER INC-2021001195 same reporter/drug/event, different patient.;US-PFIZER INC-2021001204 same reporter/drug/event, different patient.;US-PFIZER INC-2021001329 same reporter/drug/event, different patient.
49 2021-01-06 fast heart rate, palpitations she had a strong, whole body heat, and flushing; she had a strong, whole body heat, and flushing; Ta... Read more
she had a strong, whole body heat, and flushing; she had a strong, whole body heat, and flushing; Tachycardia; Palpitations; This is a spontaneous report from a contactable nurse. This nurse reported similar events for 6 patients. This is the 6th of 6 reports. A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch unknown) via an unspecified route of administration on 28Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter said her friend is a registered nurse, and received the COVID-19 Vaccine on Monday, 28Dec2020. She said her friend stated she, and 5 other registered nurses she works with, had a serious reaction right after receiving the COVID-19 Vaccine. The patient had a strong, whole body heat, and flushing. The patient said she became tachycardic and had palpitations that lasted a few minutes. She said the tachycardia and palpitations then slowly resolved in less than 5 minutes. She had no other symptoms after receiving the COVID-19 Vaccine. The registered nurse who was monitoring the people who received the COVID-19 Vaccine indicated that the same feeling had occurred in many other workers who had received the COVID-19 vaccine. The reporter did not know if the patient received any other vaccines at the same time as the COVID-19 Vaccine, and if had received any other vaccines within the last 4 weeks. The patient works at a hospital but doesn't believe that she received any medical attention. she believed just waited her symptoms out, and within 5 minutes her symptoms had gone away. The outcome of the events was recovered on 28Dec2020. Information on lot/batch number has been requested.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported whole body heat, flushing, tachycardia and palpitations, and the administration of BNT162B2, based on the reasonable temporal association and lacking alternative explanations. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.,Linked Report(s) : US-PFIZER INC-2021001345 same reporter/drug/event, different patient.
49 2021-01-07 palpitations, fast heart rate 01/08 sent email to cancel the second dose. I called her and she states after the first dose after ... Read more
01/08 sent email to cancel the second dose. I called her and she states after the first dose after about 1.5 hours started getting tachy and palpations for about 6 hours following her shot. She states her resting HR was HR 130 for about an hour but she just sat and waited it out. She denies going to ER or calling she stated she had this happen about 6 years ago and just waitied it out. She stayed and worked stating she just did inservices and after about 6 hours felt better before she states she felt fine the next day except for sore arm.
49 2021-01-07 hypertension, fast heart rate Left sided parentheses and numbness sensation which then spread to right side. Strong headache initi... Read more
Left sided parentheses and numbness sensation which then spread to right side. Strong headache initially then resolved, rapid heart rate, confusion, dizziness, high blood pressure,
49 2021-01-07 fast heart rate Metallic taste in mouth after injection. Then 45 minutes later, had rapid heart rate and itching ove... Read more
Metallic taste in mouth after injection. Then 45 minutes later, had rapid heart rate and itching over the injection side. Later that night had itching throughout body. She has since had a HA.
49 2021-01-07 blood pressure increased, fast heart rate Patient c/o generalized tingling 35 minutes after receiving vaccine. BP taken and was elevated 169/1... Read more
Patient c/o generalized tingling 35 minutes after receiving vaccine. BP taken and was elevated 169/112. tachy at 101. patient brought to ED for further evaluation.
49 2021-01-07 chest discomfort Sore throat, fever, neck and shoulder pain, heavy chest, headaches, extreme fatigue, nausea, diarr... Read more
Sore throat, fever, neck and shoulder pain, heavy chest, headaches, extreme fatigue, nausea, diarrhea; Sore throat, fever, neck and shoulder pain, heavy chest, headaches, extreme fatigue, nausea, diarrhea; Sore throat, fever, neck and shoulder pain, heavy chest, headaches, extreme fatigue, nausea, diarrhea; Sore throat, fever, neck and shoulder pain, heavy chest, headaches, extreme fatigue, nausea, diarrhea; Sore throat, fever, neck and shoulder pain, heavy chest, headaches, extreme fatigue, nausea, diarrhea; Sore throat, fever, neck and shoulder pain, heavy chest, headaches, extreme fatigue, nausea, diarrhea; Sore throat, fever, neck and shoulder pain, heavy chest, headaches, extreme fatigue, nausea, diarrhea; Sore throat, fever, neck and shoulder pain, heavy chest, headaches, extreme fatigue, nausea, diarrhea; Sore throat, fever, neck and shoulder pain, heavy chest, headaches, extreme fatigue, nausea, diarrhea; This is a spontaneous report from a contactable health care professional nurse, the patient. A 49-years-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EH9899) in the left arm on 22Dec2020 14:30 as a single dose, for COVID-19 immunization. Medical history includes Lupus, Endometriosis, Epilepsy from an unknown date and unknown if ongoing. Concomitant medication included belimumab (BENLYSTA), prednisone (PREDNISONE), topiramate (TOPAMAX), levetiracetam (KEPPRA), ergocalciferol (VITAMIN D [ERGOCALCIFEROL]). The patient previously took Percocet [oxycodone hydrochloride; oxycodone terephthalate; paracetamol], Sulfa Drugs and hibiclens and experienced drug hypersensitivity. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had been tested for COVID-19. The patient experienced sore throat, fever, neck and shoulder pain, heavy chest, headaches, extreme fatigue, nausea, diarrhea on 23Dec2020 07:00. Events continues through now 10 days later and still feel horrible. The events resulted in a physician office visit. The patient underwent lab tests that included SARS-CoV-2 test Nasal Swab (Both rapid and PCR) on 30Dec2020; influenza test and Streptococcus test on an unspecified date. The results of all laboratory tests influenza Streptococcus test and COVID (Both rapid and PCR) were negative. No treatment was received given for the events. The clinical outcome of sore throat, fever, neck and shoulder pain, heavy chest, headaches, extreme fatigue, nausea, diarrhea was not recovered.
49 2021-01-08 hypertension After the vaccine was administered I walked away maybe 50' and I started to feel dizzy I felt light ... Read more
After the vaccine was administered I walked away maybe 50' and I started to feel dizzy I felt light headed and as if I was drunk my legs feel real week they took me outside so I could catch some fridge fresh air and they set me down on a chair I was very dizzy my legs and my knees felt like I couldn't stand up and they were very weak I kept seeing a the rails double vision and I started to have a tightness in the back of my neck I felt they warrant come over my head and my forehead got very very cold And then I felt as I was gonna blackout and pass out and I was gasping for air and suddenly my tongue went into a spasm and it went to the top of my the roof of my Roof of my mouth and I couldn't breathe and I was able to send a message for someone to come and help me as I was sitting there by myself they rushed over by now looking at my text message it was for 02 which was within 15 minutes of the vaccine when I had my 1st episode and then minutes after that 3 more came with the same oh unable to swallow I lost the ability to swallow and my tongue fell like I had no control it was just automatically stuck to the roof of my mouth.. Upon the arrival of Ems I was told there was no treatment and there was nothing they could do told me to wait 24 to 48 hours in the symptoms should subside it's been over 72 hours in the symptoms are still occurring. I continue to feel dizzy light headed and now have high blood pressure which was not present before visit ER prescriptions for steroids with issued, I Told to go home and rest. Followed up with family doctor in the morning and was told it was not an allergic anaphylactic reaction probably more so neurologically ransom blood tests waiting for results continue to have loss of control over tounge spasms unable to eat Accompanied by fatigue dizziness and high blood pressure
49 2021-01-08 hypertension Angioedema, HYPERtension, Narrative: Lips swollen and hypertension. Lips less after 20 mins
49 2021-01-08 chest pain Got out of bed, after a few minutes of standing vision became white, sudden onset of severe diaphor... Read more
Got out of bed, after a few minutes of standing vision became white, sudden onset of severe diaphoresis, then unable to stand, fell to the floor then could not see at all, everything was black, also unable to speak, sudden onset of shortness of breath, central chest pain, pain to shoulders and neck. Ears ringing, pain to back of head. Approximately 15 min later was able to speak and crawl to edge of bed. Sweating remained at this time along with extreme weakness, lightheaded and nausea. Heart rate 118, oxygen was 96% by finger oximeter. 10 minutes later dressed with assistance and able to ambulate independently but slowly to truck to be taken to ER.
49 2021-01-08 fast heart rate mouth itching, slight tongue swelling, tachycardia, coughing, feeling of impending doom, nausea, vo... Read more
mouth itching, slight tongue swelling, tachycardia, coughing, feeling of impending doom, nausea, vomiting, diarrhea, itching This started at minute 13 after the vaccine administration. I have had several infusion reactions before to biologics to treat my autoimmune disease and this is how it always starts. There was nothing available at the administration place so I left and took zyrtec, benadryl and pepcid. The symptoms stopped in about 25 minutes.
49 2021-01-09 blood pressure increased I received COVID 19 Pfizer vaccine on 12/23/20 and on 12/27/20 my blood pressure started to spike wi... Read more
I received COVID 19 Pfizer vaccine on 12/23/20 and on 12/27/20 my blood pressure started to spike with readings 150's/100's while well controlled on medication- Metoprolol 25 mg tab daily. My BP remained elevated on 12/28 and i subsequently went to the ER and had chest XRay; EKG and cardiac workup done with all tests negative. I was instructed by ER Doctor to follow up with my cardiologist- Dr. and he subsequently changed my medication regimen to Metoprolol 25 mg tab twice daily. Since that episode my BP has been well controlled. I am not sure if there is a correlation with the vaccine. However i am bringing to your attention as i have never had a spike in BP while on BP meds.
49 2021-01-10 chest discomfort Fever, fatigue , chest heaviness, cough. Treatment: Robutussin, Motrin. Fever and fatigue improved.
49 2021-01-10 palpitations Within 20 min of administration my face began to become Hot. Shortly after It felt as if I had gotte... Read more
Within 20 min of administration my face began to become Hot. Shortly after It felt as if I had gotten a CT contrast, where my whole body began to feel warm, also a metallic taste in my throat. A few hours later I had a horrible headache, with tightness in my chest and palpitations. My muscles and joints ached, my hands became swollen and I was unable to remove my ring. These symptoms continued for 24 hours. I also experienced shortness of breath.I almost took myself to ER. They eventually went away and I feel fine now
49 2021-01-11 hypertension Elevated blood pressure and headache at immediate injection body aches about 2 hours later follow by... Read more
Elevated blood pressure and headache at immediate injection body aches about 2 hours later follow by nausea low grade temp. On Sunday about 4am I started vomiting with diarrhea, joint pain, Headache, BP of 168/109 and temperature of 100.1.
49 2021-01-11 hypertension The patient received the vaccine at 10 am and an hour later the patient experienced slight dizziness... Read more
The patient received the vaccine at 10 am and an hour later the patient experienced slight dizziness, sweating, and shakiness. The ambulance was called just to be on the safe side. She was taken to the hospital via ambulance and was later discharged that same night as symptoms improved.
49 2021-01-12 palpitations, heart rate increased "Information regarding possible side effects I found to be odd. I experienced heart palpitations the... Read more
"Information regarding possible side effects I found to be odd. I experienced heart palpitations the day after the injection until today. This continued in episodes for 48 hours. I also experienced an increase in HR. I usually have a pulse of around 70-74. Post injection it stayed at 94-95 for an entire day with the palpitations."
49 2021-01-12 chest discomfort Patient describes flu like symptoms, sore arm at injection site, congestion with no cough but feels ... Read more
Patient describes flu like symptoms, sore arm at injection site, congestion with no cough but feels "heavy in her chest".
49 2021-01-12 chest discomfort Reported feeling flushed and experienced chest pressure. Transferred to ED
49 2021-01-13 fast heart rate, chest discomfort 1st dose 12/21/20 with no reported side effects. 3:00pm c/o blurred vision BP 180/110 neck and ches... Read more
1st dose 12/21/20 with no reported side effects. 3:00pm c/o blurred vision BP 180/110 neck and chest tightness headache 5:30pm BP 172/109 tachycardia and SOB nausea BP still 185/107 so went to prompt care who sent via ambulance to ER. Given nitro, fluids and morphine. Sent home. Next morning BP 188/118 and 213/122. C/o body aches temp 99 and loss of smell and taste. Saw primary care provider 1/14/21. Added Lisinopril and increased current betablocker and said was vaccine reaction. BP there 209/122 pulse 126. PCP did not test for COVID. Reports she did Binax test herself after visit and was negative
49 2021-01-13 heart rate increased Resident had immediate elevation of heart rate with discharge heart rate after 15 min monitoring of ... Read more
Resident had immediate elevation of heart rate with discharge heart rate after 15 min monitoring of 135 bpm.
49 2021-01-13 heart rate increased felt dizzy; left arm soreness; 'knot' noted on left deltoid Itchy, but painful/indurated area of ery... Read more
felt dizzy; left arm soreness; 'knot' noted on left deltoid Itchy, but painful/indurated area of erythema; 'knot' noted on left deltoid Itchy, but painful; pulse 77 to 94 from lying to standing; 'knot' noted on left deltoid Itchy, but painful/left lateral deltoid with 3.75 x 5 cm mildly tender; indurated area of erythema, with central erythematous punctum (presumed site of injection); indurated area of erythema, with central erythematous punctum (presumed site of injection); This is a spontaneous report from a contactable pharmacist. A 49-year-old female patient (non-pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0142, 30mcg/0.3ml), intramuscular on 31Dec2020 15:38 (also reported as 08:30 am) at 0.3 mL, single at left deltoid for covid-19 immunization. Medical history included significant for Covid 19 infection (positive test 28Oct2020), shortness of breath, dizzy, hospitalized for decreased O2 saturation from 04Nov2020. Patient was treated with remdesivir for Covid 19 infection. The patient's concomitant medications were not reported. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, it was unknown if patient had been tested for COVID-19. Patient felt dizzy after receiving injection on 01Jan2021, left arm soreness noted during night; 'knot' noted on left deltoid, when awoke on 01Jan2021; knot grew to 5x5 cm max size over 48 hours, itchy, but painful if tried to scratch. Some dizziness with position change. Examination: no fever, no orthostatism to BP, pulse 77 to 94 from lying to standing, left lateral deltoid with 3.75 x 5 cm mildly tender, indurated area of erythema, with central erythematous punctum (presumed site of injection). Patient took diphenhydramine hydrochloride (BENADRYL) 03Jan2021, and cetirizine hydrochloride (ZYRTEC) 04Jan2021 for events (Instructed to take OTC antihistamine (cetirizine hydrochloride) daily until 7 days after symptoms resolve). Adverse events resulted in doctor or other healthcare professional office/clinic visit. Patient received treatment diphenhydramine, certitizine for events. The report is considered as non-serious. Outcome of events was unknown.
49 2021-01-13 fast heart rate, palpitations heart palpitations and tachycardia, mild resolved within 9 hours of administration; after that, feve... Read more
heart palpitations and tachycardia, mild resolved within 9 hours of administration; after that, fever and myalgia x 6 hours; next day, general myalgia only
49 2021-01-14 chest pain At 6 days after my second COVID-19 Pfizer vaccine (first dose given 12/17/20), I had acute onset of ... Read more
At 6 days after my second COVID-19 Pfizer vaccine (first dose given 12/17/20), I had acute onset of chest pain and shortness of breath prompting a trip to the Emergency Department. A chest CT Angio to rule out pulmonary embolus was done and negative for pulmonary embolus. My EKG showed some mild ST changes and a troponin I level was elevated at 0.08 (normal 0.04). Subsequent troponin levels 90 minutes apart showed a rising troponin at 0.18 and 0.38. An echocardiogram was performed which showed regional wall motion abnormalities consistent with Takotsubo cardiomyopathy and an ejection fraction of 45%. I was then taken to cardiac catheterization lab for coronary angiograms which were normal. My LV angiogram was consistent with Takotsubo cardiomyopathy and my LVEDP was elevated. I was started on a beta blocker and sent home the following day.
49 2021-01-14 blood pressure increased Burning and itching at site, increased blood pressure, redness and burning down both arms, redness i... Read more
Burning and itching at site, increased blood pressure, redness and burning down both arms, redness in face, hot, sweaty, and cold
49 2021-01-14 chest pain Patient had headache with dizziness about 30" after injection. 90" later had sudden onset left-sided... Read more
Patient had headache with dizziness about 30" after injection. 90" later had sudden onset left-sided Chest pain with difficulty breathing. Patient's chest pain was so bad she thought she was going to die. Was transported to ER via ambulance, had cardiac workup, blood clot workup (had left leg pain the day before incident). Was discharged home on zanaflex and motrin with diagnosis of Chest Wall pain about 4 hours later. Follow up on 1.15.2021 at 1000 and patient doing better but still has chest pain. Will not be getting 2nd COVID vaccination.
49 2021-01-15 heart rate increased, palpitations Day 10 post injection I experienced: Severe Headache Palpitations Increased Heart Rate SOB Cough Diz... Read more
Day 10 post injection I experienced: Severe Headache Palpitations Increased Heart Rate SOB Cough Dizziness Lightheadedness Fatigue Chills Sneezing Sore arm (first 3-4 days). I had a negative COVID test on 1/12/21.
49 2021-01-16 lightheadedness Sig stomach and gut cramps to the point of near syncope. Missed half day work. Nausea, lack of appet... Read more
Sig stomach and gut cramps to the point of near syncope. Missed half day work. Nausea, lack of appetite. Lasted over 4 hs severe, 12 hs moderate
49 2021-01-17 loss of consciousness headache, chills ( all day of Jan.17) feels icy cold around my ears and face temp. 97, warm/hot temp... Read more
headache, chills ( all day of Jan.17) feels icy cold around my ears and face temp. 97, warm/hot temp 98.9, nausea, blurry vision, pass out once 2-3 mins, feverish at night 99.9
49 2021-01-18 palpitations 10 mins after first dose - Flushed, heart racing and head pressure. BP 139/89 - HR 115 Took Benedryl... Read more
10 mins after first dose - Flushed, heart racing and head pressure. BP 139/89 - HR 115 Took Benedryl 25 mg P.O. Denied ER visit Released home.
49 2021-01-18 fast heart rate Tachycardia; Itching hives on the trunk and bilateral arms with 15 minutes; Facial Flush; This is a ... Read more
Tachycardia; Itching hives on the trunk and bilateral arms with 15 minutes; Facial Flush; This is a spontaneous report from a contactable nurse (patient). A 49-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration (Arm Right) first dose on 08Jan2021 at single dose for covid-19 immunisation. The patient's medical history included known allergies: Bee Venom, Coconut, and Shellfish. The patient's concomitant medication included vitamin b complex (B COMPLEX [VITAMIN B COMPLEX]), metoprolol, zolpidem tartrate (AMBIEN), and dexmethylphenidate hydrochloride (FOCALIN [DEXMETHYLPHENIDATE HYDROCHLORIDE]). The patient previously took Fenofibrate and experienced allergies. On 08Jan2021, the patient experienced Itching hives on the trunk and bilateral arms with 15 minutes, Facial Flush, Tachycardia, Elevated. The patient was treated with Benadryl. The patient went Emergency room/department or urgent care due to the events. The outcome of the events was recovered in Jan2021. Facility where the most recent COVID-19 vaccine was administered in Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 Prior to vaccination and was not been tested for COVID-19 since the vaccination. Information on the lot/batch number has been requested.
49 2021-01-18 blood glucose increased Woke up shivering at 1 A.M. Saturday so bad that my husband thought I was having a seizure, took my... Read more
Woke up shivering at 1 A.M. Saturday so bad that my husband thought I was having a seizure, took my temp it was 104. Took Tylenol, held cool compress on my forhead, the next day had bad chills, throbbing headache, and temp never dropped below 100. I was very weak, every muscle in my body ached, couldn't eat, yet my blood sugar was high all day. Kept checking my temp. It was avg. 102 . Read about the side effects, seemed like I just had it worse than others. Then into Monday morning, still felt awful, but had woke up in a pool of sweat, temp finally fell to 99 . Seemed like the worst was past, was able to eat a little breakfast, but then the diahrea started! I called in sick again, and went to Urgent care. The Dr. said I had a severe adverse reaction to the second vaccine. I asked for a Covid test just in case. Now Tuesday, felt better today, still a bit tired, temp has been avg. of 98 today, got results from test, negative.
49 2021-01-19 blood clot "I received the Pfizer Covid vaccine Wed afternoon around 4pm. Thursday morning around 9:30 I starte... Read more
"I received the Pfizer Covid vaccine Wed afternoon around 4pm. Thursday morning around 9:30 I started with severe pain in my left leg. The pain worsened through the day and my leg began swelling. No other symptoms at all. This morning my leg was twice the size of my right leg so I went to the ER. I live in so I'm at ED. I have a massive blood clot running the the length of my leg - from my thigh to my ankle. I'm very lucky I got here so fast! I?m a very healthy 49 year old with no history of DVT or blood clots so they dug further to find out why. A cat scan showed I have a congenital condition called May Thurner Syndrome. I?m so relieved to have an answer and it?s fixable! The vascular doctors are not 100% convinced that?s not all that was going on as I was born with the syndrome and I?ve gone this long without a clot. So they are doing lots of labs to see if anything else shows up. This is where we are at. I?m being admitted to take care of the clot."
49 2021-01-19 blood pressure increased Day 1, loose stools that night. Day 2, loose stools and a sore throat. Day 3, sore throat and runny ... Read more
Day 1, loose stools that night. Day 2, loose stools and a sore throat. Day 3, sore throat and runny nose. Day 4, nose runny like a faucet and cough. Day 5, runny nose, sore throat, coughing a lot. Took some Theraflu. Day 6, no more sore throat but coughing and some shortness of breath on exertion and at rest. Day 7, coughing, nose not running as much, shortness of breath still present. Day 8, shortness of breath, coughing a lot. Day 9 (Tuesday, January 19, 2021) still coughing and experiencing Shortness of breath. Texted my manager and explained whatvhad been going on since I got the second vaccine and that I wasn't sick prior to getting it. And that no other family member in my home was sick besides me. She put me in touch with the HR director who scheduled n e for a COVID test that same night. I went to have the test done and also had the ER doctor to evaluate me because I was feeling so bad with the coughing and Shortness of breath. Today, I am still coughing, producing nasal drainage, and feeling short of breath at times.
49 2021-01-19 blood pressure increased, chest discomfort Tongue swelling, throat and chest tightness
49 2021-01-19 chest discomfort generalized numbness and tingling down both arms extending from shoulders to fingers, transient sens... Read more
generalized numbness and tingling down both arms extending from shoulders to fingers, transient sensation of bandlike chest tightening across rib cage, BP 156/94 with pulse oximetry 98, pulse 111. Observed one hour without allergic signs or symptoms and no wheezing.
49 2021-01-19 lightheadedness, chest discomfort he received her first Covid 19 vaccination shot and shortly thereafter became lightheaded, dizzy, mi... Read more
he received her first Covid 19 vaccination shot and shortly thereafter became lightheaded, dizzy, mildly short of breath, and developed a headache. She reports that her symptoms occurred approximately 10-15 minutes after receiving the shot and started after she walked a short distance and then sat down when she became mildly short of breath, had one episode of chest tightness that since resolved. She also had acute onset 6 out of 10 left-sided frontal headache that has stayed constant since onset. She feels that the room is spinning around her however does not feel that she is presyncopal. Impression: Vasovagal reaction w/ mild allergic reaction to vaccine
49 2021-01-20 blood clot Felt like a restless leg or blood clot but not as severe.; Felt like a restless leg or blood clot bu... Read more
Felt like a restless leg or blood clot but not as severe.; Felt like a restless leg or blood clot but not as severe.; Left below knee pain and discomfort. Some to the right leg as well.; Left below knee pain and discomfort. Some to the right leg as well.; Checked back of leg for warmth or bruising lasted day 2 and day 3.; Checked back of leg for warmth or bruising lasted day 2 and day 3.; Did feel some discomfort to left arm as a result of the shot in left arm, tender and could feel when holding arm up some discomfort; This is a spontaneous report from a contactable nurse reporting for herself. A 49-years-old female patient started to receive bnt162b2 (BNT162B2; Lot: ECO142) vaccine , intramuscular in the left arm on 29Dec2020 15:45 at single dose for Covid-19 immunisation . Medical history included hypertension, anaemia, blood cholesterol increased , depression, food allergy (whey casium) (taking doxepin for it with relief). Concomitant medication included doxepin (DOXEPIN), metoprolol (METOPROLOL), calcium ascorbate (VITAMIN C [CALCIUM ASCORBATE]), tocopherol (VITAMIN E [TOCOPHEROL]), cyanocobalamin (VITAMIN B-12) , atorvastatin (ATORVASTATIN), sertraline (SERTRALINE). The patient experienced felt like a restless leg or blood clot but not as severe. on 30Dec2020 07:00 with outcome of recovered , left below knee pain and discomfort. some to the right leg as well. on 30Dec2020 07:00 with outcome of recovered , checked back of leg for warmth or bruising lasted day 2 and day 3. on 30Dec2020 07:00 with outcome of recovered , did feel some discomfort to left arm as a result of the shot in left arm, tender and could feel when holding arm up some discomfort on 30Dec2020 07:00 with outcome of recovered. The event blood clot was considered serious (Important Medical Event). Course of the events The patient reported left below knee pain and discomfort. Some to the right leg as well. She checked back of leg for warmth or bruising lasted day 2 and day 3. She felt like a restless leg or blood clot but not as severe. She felt better to stand instead of sitting. Did feel some discomfort to left arm as a result of the shot in left arm, tender and could feel when holding arm up some discomfort. No shortness of breath, no nausea, no dizziness, no increased fatigue (baseline - not enough sleep - working 3 jobs).; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported leg thrombosis cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
49 2021-01-20 palpitations, heart rate increased Patient has had a history of an egg allergy as a kid, so she takes prednisone prior to flu immunizat... Read more
Patient has had a history of an egg allergy as a kid, so she takes prednisone prior to flu immunizations to reduce any signs of allergic reaction. To prepare for this vaccine, she premedicated with prednisone from Monday-Friday. While sitting in observation, she notice that her heart was racing- at that time her heart rate was 132 bpm, and she was advised to go to the ED for further evaluation. Upon arrival at ED, her HR had reduced to 106 bpm at 0958. She was monitored and discharged at 1013 at which point to returned to work as a nurse without problem.
49 2021-01-20 palpitations, fast heart rate anxiety, tachycardia, palpitations. all symptoms resolved during observation period of 30 minutes.
49 2021-01-20 heart rate increased, chest discomfort fast heart rate; tingling in feet; mild tightness in the chest; shaking chills; sore arm; body aches... Read more
fast heart rate; tingling in feet; mild tightness in the chest; shaking chills; sore arm; body aches; headaches; This is a spontaneous report from a contactable physician (reporting for herself). A non-pregnant 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscularly in the right arm on 23Dec2020 12:00 at a single dose for COVID-19 immunization. Medical history included hashimoto thyroiditis and hypertension. Concomitant medication included levothyroxine sodium (SYNTHROID), hydrochlorothiazide (HCTZ), biotin, cyanocobalamin, folic acid (MVI 3), influenza vaccine inact split 3v (FLULAVAL) taken for immunization on 03Dec2020. On 23Dec2020 12:15, the patient experienced fast heart rate, tingling in feet, mild tightness in the chest, shaking chills, sore arm, body aches and headaches. The patient underwent lab tests and procedures which included heart rate: fast on 23Dec2020. There was no treatment given for any of the events. The outcome of the events was recovered in Dec2020. The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
49 2021-01-21 fast heart rate Achy arm Body Aches Fast heart beat
49 2021-01-21 palpitations Fatigue, shortness of breath, headache, heart palpitations, muscle aches, joint pain, all of these f... Read more
Fatigue, shortness of breath, headache, heart palpitations, muscle aches, joint pain, all of these for 8 days after then low grade fever 99.6 for 24 hours after other symptoms improved. Left with unusual fatigue during normal activities.
49 2021-01-21 loss of consciousness, hypotension High Fever of 104 degrees F for a duration of 18 hours, Orthostatic Hypotension with Bp as low as 63... Read more
High Fever of 104 degrees F for a duration of 18 hours, Orthostatic Hypotension with Bp as low as 63/40 in supine for a duration of 18 hours, repeated loss of consciousness due to low BP
49 2021-01-21 chest discomfort, palpitations Individual felt dizzy and had a severe headache about 15 min post injection of 2nd vaccination. We ... Read more
Individual felt dizzy and had a severe headache about 15 min post injection of 2nd vaccination. We sat her down and then she said her chest felt tight and said she felt as if her heart was racing. Went unresponsive, still breathing, for almost 1 min. Came to and then began to dry heave. Her breathing became wheezy and rapid and her bottom lip began to turn blue. We administered an EpiPen about 5:03pm and the rescue squad took her to the hospital. They administered Benadryl and Ativan in the ER and sent patient home that evening.
49 2021-01-21 heart rate increased, chest discomfort Within about 15 min my heart rate started going up.. it has been running 120-130 since I got it. I ... Read more
Within about 15 min my heart rate started going up.. it has been running 120-130 since I got it. I feel short of breath. I have pounding in my chest. I got dizzy after a bath and almost fell. I am very well hydrated I have drank at least 2 liters of water. I can?t get rid of my headache or body aches. I have taking ibuprofen , Pepcid , zomig for my headache which didn?t help , 600 mg of gabapentin, 20 of prednisone .. I feel like I can?t get enough air.
49 2021-01-24 hypertension, heart rate increased High heart rate, hypertension
49 2021-01-25 heart rate decreased ? Covid-19 Vaccine, Mrna, Bnt162b2, Lnp-S (Pfizer) Anaphylaxis sleepiness, Swelling face and throat... Read more
? Covid-19 Vaccine, Mrna, Bnt162b2, Lnp-S (Pfizer) Anaphylaxis sleepiness, Swelling face and throat, breathing difficulty, cough, aphasia-pt was not able to express her thoughts or needs, pt felt that her heart was beating slow, vomiting started next day and lasted for 4 days, self treatment immediately by pt- Benadryl 50 mg and albuterol inhaler, later Prednisone course by medical professional symptoms completely resolved after 5 days
49 2021-01-25 chest discomfort Fever, headache, very bad body aches, chest pressure, dizziness and missed two days of work
49 2021-01-26 palpitations Patient c/o palpitations after receiving 2nd COVID vaccine. Her HR was 140-160. No CP, no SOB or diz... Read more
Patient c/o palpitations after receiving 2nd COVID vaccine. Her HR was 140-160. No CP, no SOB or dizziness. Went down to 86 and she felt better and left the clinic. she returned to the clinic 20 minutes later c/o palpitations again. Her HR was then 112. Transported to ED for eval and treatment.
49 2021-01-26 chest discomfort Patient received her 2nd Pfizer vaccination dose around 11:45. Was observed for 15 minutes and then ... Read more
Patient received her 2nd Pfizer vaccination dose around 11:45. Was observed for 15 minutes and then left the clinic. She returned to the clinic 30 minutes later with complaints of dizziness, chest pressure, and tingling on her tongue. She ambulated in with her husband. She also stated she has a history of anxiety and was not sure if this was related to that or not. Due to the ongoing chest pressure, she was advised to go to the ED for further assessment. Per ED note, patient left the ED prior to receiving a medical screening exam by provider.
49 2021-01-27 chest pain Everyday-fatigue 25th Jan 2021-HA @1500, pain at injection site 26th Jan-0930-shaking uncontrollable... Read more
Everyday-fatigue 25th Jan 2021-HA @1500, pain at injection site 26th Jan-0930-shaking uncontrollable-she states, COLD, body aches, HA, nauseated, sweating, muscular & joint pain 27th Jan-decreased symptoms some, intermittent SOB, chest pain, rt & left sides 28th Jan-SOB-continues, -she has a history of seasonal allergies, Told to go to the ER if her SOB & chest pain gets worse. Took Tylenol & Motrin for the body aches, HA, joint pain and discomforts Can't walk-gets fatigued-even short distances
49 2021-01-27 hypertension My blood pressure went up all the way to 197/139
49 2021-01-27 palpitations Pt developed palpitations(felt like heart was racing) and metallic taste in mouth a few minutes afte... Read more
Pt developed palpitations(felt like heart was racing) and metallic taste in mouth a few minutes after injection. Patient noted that symptoms were mild and were improving. She declined EMS services/hospital evaluation and elected to go home after appx. 30 minutes of observation. HR and BP were both within normal limits.
49 2021-01-28 hypertension BP 218/116; headache; cold sweats; shivering; This is a spontaneous report from a contactable nurse ... Read more
BP 218/116; headache; cold sweats; shivering; This is a spontaneous report from a contactable nurse (patient) reported that a 49-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EKS730), via an unspecified route of administration on the right arm on 20Dec2020 11:15 at a single dose for Covid-19 immunization. Medical history included allergic rhinitis and atopic dermatitis both from an unspecified date. Patient is not pregnant. Concomitant medications included montelukast sodium (SINGULAIR), cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), doxycycline, prednisone, and diphenhydramine hydrochloride (BENADRYL); all were taken from an unspecified date for an unspecified indication. The patient received the second dose of other vaccine (unspecified, Pfizer product, lot number: EK9231), via an unspecified route of administration on the right arm on 14Jan2021. On 20Dec2020 11:45, the patient had headache, cold sweats, shivering, and BP (blood pressure) 218/116. The patient called Rapid Response Nurse, and she was wheeled to the hospital E.R. The patient was seen by a doctor and opted to just monitor her BP, no medication or IV line started. The patient was discharged with SBP of 159. The outcome of the event BP (blood pressure) 218/116 was recovering while the rest of the events was unknown.; Sender's Comments: The subject received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 20Dec2020 11:15. On 20Dec2020 11:45, the patient had blood pressure high, 218/116 mmHg. Based on information available, the reported high blood pressure was probably causally related to the first dose of BNT162B2, considering the plausible temporal relationship, and clinical course. However, the concomitant medications, especially prednisone, for unspecified indications, could be confounding factors. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
49 2021-01-28 blood pressure increased, palpitations PT stated had not eaten breakfast or lunch today. Received tragic news prior to appointment. 5 min a... Read more
PT stated had not eaten breakfast or lunch today. Received tragic news prior to appointment. 5 min after vaccination felt dizziness heart racing ,pulse 96, 2:05 pm BP 158/80 Pulse-87, SP02 97% RR 12 2:06 pm. Given crackers and water. 2:30 pm BP 138/80 P 78 Pulse ox 98% RR 12. Patient feeling better "normal" agreeing to wait for 25 more minutes. 2:55 pm. Patient feeling well instructed to call 911 if symptoms recur or worsen.
49 2021-01-28 heart rate increased Patient had increased heart beat, sweating and dizzy. Was transported to ER where she was administer... Read more
Patient had increased heart beat, sweating and dizzy. Was transported to ER where she was administered Benadryl IV for 15 minutes. She was then realesed and followed up by primary care. Was prescribed Alprazolam 0.5mg bid and Naproxen 500 bid. Patient feels fine now.
49 2021-01-28 palpitations Started with low grade fever 99.8, throbbing headache, muscle aches, chills, this happened 1/28 6 pm... Read more
Started with low grade fever 99.8, throbbing headache, muscle aches, chills, this happened 1/28 6 pm , then took some ibuprofen. Hardy time sleeping. Next day 1/29 fever 100.4, chills, increased muscle aches, headache still and now heart palpitations. Took ibuprofen again, but not much relief.
49 2021-01-30 blood pressure increased My bp went up to 182/101 a couple hours after vaccine., had a bad headache, tired and flushed feelin... Read more
My bp went up to 182/101 a couple hours after vaccine., had a bad headache, tired and flushed feeling. Had to take BP meds again n lay down, seemed to go down after an hour of taking BP meds to 140/89
49 2021-01-31 chest pain, chest discomfort . In addition I felt a retrosternal chest discomfort/scratchiness/tightness that has been intermitte... Read more
. In addition I felt a retrosternal chest discomfort/scratchiness/tightness that has been intermittent; . In addition I felt a retrosternal chest discomfort/scratchiness/tightness that has been intermittent; . In addition I felt a retrosternal chest discomfort/scratchiness/tightness that has been intermittent; local pain/bodyache; Fatigue; feverish feeling; dry cough; This is a spontaneous report from a contactable Physician (patient). A 49-years-old female patient (no pregnant) received the second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) , intramuscular on 08Jan2021 11:00 at single dose at left arm for covid-19 immunisation . Medical history included bee sting. There were no concomitant medications. The patient previously received the first dose bnt162b2 on 18Dec2020 10:30 AM at Left arm. The patient experienced a retrosternal chest discomfort, scratchiness, tightness that has been intermittent, local pain, bodyache, fatigue, feverish feeling, dry cough on 08Jan2021. The patient did not received any treatment for the events. The patient underwent lab tests and procedures which included nasal swab: negative on 26Aug2020. The outcome of events was not recovered. No other vaccine in four weeks; No covid prior vaccination; Information on the Batch/Lot number has been requested.
49 2021-01-31 pulmonary embolism, fibrin d dimer increased, fast heart rate Patient began having increasing shortness of breath about a week after receiving first dose of Pfize... Read more
Patient began having increasing shortness of breath about a week after receiving first dose of Pfizer COVID-19 vaccine. Symptoms worsened and persisted to the point where patient called her PCP on 1/26/2021, who advised her to report to ED if experiencing worsening symptoms and/or low oxygenation. Patient reported to ED on 1/29/2021 due to tachycardia and O2 sats <90%. On presentation, patient was found to have bilateral pulmonary emboli involving the upper and lower lobe regions bilaterally including segmental branches without evidence of right heart strain.
49 2021-02-02 fainting Severe headache; malaise; fatigue; syncope and collapse - orthostatic hypotension; Orthostatic hypot... Read more
Severe headache; malaise; fatigue; syncope and collapse - orthostatic hypotension; Orthostatic hypotension; This is a spontaneous report from a contactable nurse (patient). A 49-year-old female patient (non-pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration on 18Dec2020 at single dose at right arm for covid-19 immunization. Medical history included chronic fatigue, hypothyroidism, allergic rhinitis from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine, patient didn't receive other medication within 2 weeks of vaccination. The patient previously took promethazine hydrochloride (PHENERGAN) and experienced allergies: phenergan. After 1st dose, patient had severe headache for five days, malaise, fatigue on 19Dec2020 09:45 PM, day 6 syncope and collapse - orthostatic hypotension in Dec2020. The adverse events resulted in emergency room/department or urgent care. Adverse events treatment included CT head, carotid doppler, echocardiogram, lab work. It was unknown if the patient was not diagnosed with COVID-19 prior to vaccination. Covid test type post vaccination included nasal swab on 24Dec2020: negative. Patient received second dose of bnt162b2 (lot number: el0142) on 08Jan2021 10:00 at single dose at left arm for covid-19 immunization. Outcome of events was recovered on unspecified date.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of syncope, orthostatic hypotension and other events due to temporal relationship. However, the events may likely possibly represent concurrent medical conditions in this patient. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including head CT/MRI, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
49 2021-02-02 chest discomfort, lightheadedness Vasovagal reaction; allergic reaction to vaccine; became lightheaded, dizzy; mildly short of breath;... Read more
Vasovagal reaction; allergic reaction to vaccine; became lightheaded, dizzy; mildly short of breath; developed a headache/onset 6 out of 10 left-sided frontal headache; chest tightness; room is spinning around her however does not feel that she is presyncopal; This is a spontaneous report from a contactable pharmacist. A 49-year-old female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EJ1685; expiration date: unknown), intramuscular left arm on 18Dec2020 20:00 at a single dose for covid-19 immunization. Medical history included wheezing, hypertension, hyperlipidaemia and non-insulin-dependent diabetes. She was not diagnosed with Covid prior to vaccination. The patient has no known allergies. It was unknown if the patient was pregnant at the time of vaccination. Concomitant medication included salbutamol sulfate (ALBUTEROL) for wheezing, fluticasone propionate (FLOVENT HFA), hydrochlorothiazide, losartan potassium (LOSARTAN HYDROCHLOROTHIAZIDE ACTAVIS), pravastatin, colecalciferol (VIT D3), colecalciferol (VITAMIN D3 1000), latanoprost and metformin. The patient did not receive other vaccine in the last four weeks. On 18Dec2020, the patient reported that she received her first Covid 19 vaccination shot in a hospital and shortly thereafter became lightheaded, dizzy, mildly short of breath, and developed a headache. She further reported that her symptoms occurred approximately 10 to 15 minutes (reported onset time of 08:00 PM) after receiving the shot and started after she walked a short distance and then sat down when she became mildly short of breath, had one episode of chest tightness that since resolved. She also had acute onset 6 out of 10 left-sided frontal headache that has stayed constant since onset. She feels that the room is spinning around her however does not feel that she is presyncopal. The impression was vasovagal reaction with mild allergic reaction to vaccine. The adverse events resulted in an emergency room/department or urgent care visit and treatment was received for the adverse events which included ketorolac 15mg x 1 dose, meclizine 25mg x 1 dose, NaCl 1,000 mL bolus. The patient was not COVID tested post vaccination. The outcome of the events was recovered on an unspecified date.; Sender's Comments: Based on the compatible time association, the possible contribution of suspect vaccine BNT162B2 to the events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
49 2021-02-03 chest pain Around 1325 starting having chest pain and nausea. States pain is similar to heart burn and is const... Read more
Around 1325 starting having chest pain and nausea. States pain is similar to heart burn and is constant.
49 2021-02-03 blood pressure increased Elevation of Blood pressures proceeded with high 155/95; heart flutter; extreme breast tenderness; a... Read more
Elevation of Blood pressures proceeded with high 155/95; heart flutter; extreme breast tenderness; axillary swelling; felt general unwell feeling; This is a spontaneous report from a contactable healthcare professional reporting for self. This 49-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number= EL0140) via intramuscular on 18Dec2020 12:00 PM at right arm at single dose for COVID-19 immunization. Medical history included known allergies: cinnamon. Patient did not have COVID prior vaccination. Concomitant medications included cyanocobalamin (B12), zinc, 4-(4-hydroxyphenyl)butan-2-one, crocus sativus, magnesium oxide (BELL DE NUIT PRECIOUS MAGICAL). It was reported that first day approx 6 hours after injection patient felt general unwell feeling, next day (19Dec2020) extreme breast tenderness and initiation of axillary swelling. At day 10 post injection (28Dec2020) she experienced some type of heart flutter. Elevation of Blood pressures proceeded with high 155/95 on unspecified date. PCP visit with normal EKG and blood work following week. BP in office 135/85 (from memory). Patient did not receive second dosage at day 21 and BP has currently returned to normal this a.m. (20Jan2021) 117/68. There was no treatment received for events. Patient did not test COVID post vaccination. The outcome of events was recovered.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
49 2021-02-03 chest discomfort Employee reported hives, chest tightness, rash, pruritus and lip tingling 2 hours post injection. S... Read more
Employee reported hives, chest tightness, rash, pruritus and lip tingling 2 hours post injection. She was given Benadryl 50 mg IM at 1117
49 2021-02-03 heart rate increased Have had intermittent difficulty catching my breath and heart beating fast since administration of t... Read more
Have had intermittent difficulty catching my breath and heart beating fast since administration of the 2nd vaccine. Symptoms started the day after the vaccine and have continued for 4 days.
49 2021-02-03 palpitations She had chills at 5pm, by 8pm she had heart palpitations, beat red face, nausea and swollen glands i... Read more
She had chills at 5pm, by 8pm she had heart palpitations, beat red face, nausea and swollen glands in throat. She then went to bed. She woke up around 10pm and felt fatigued but better.
49 2021-02-03 fainting Systemic: Anaphylaxis-Severe, Systemic: Fainting-Severe, Systemic: Seizure-Severe
49 2021-02-03 heart rate increased, blood pressure increased Weakness; fatigue; small breathes like slightly short of breath; body aches/ severe tender and painf... Read more
Weakness; fatigue; small breathes like slightly short of breath; body aches/ severe tender and painful lymph nodes-to neck and groin and around sides; low grade fever; abdominal pain one day; all days lymph nodes pain /neck lymph node aches/ severe tender and painful lymph nodes-to neck and groin and around sides, under ribs; tenderness, especially around the side rib cage and waist area; tenderness especially around the side rib cage and waist area/ severe tender and painful lymph nodes-to neck and groin and around sides; feeling really bad like i want to cry; slight headache; night sweats; rapid heart rate; increased blood pressure; severe tender and painful lymph nodes-to neck and groin and around sides, under ribs; severe tender and painful lymph nodes-to neck and groin and around sides, under ribs; tenderness to flank area; difficult to turn in bed and lie on right side; Itchiness but no visible rash; first dose of bnt162b2 on 28Dec2020 and second dose on 12Jan2021; This is a spontaneous report from a contactable nurse (patient). A 49-year-old female patient received the second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: Unknown), via an unspecified route of administration at the right arm on 12Jan2021 at a single dose for COVID-19 immunization. Medical history included taking medication for focus (adult adhd?); perimenopausal. She also has known allergies: sulfa; shrimp, strawberry/raspberry flavored foods or candies. The patient was not pregnant at the time of vaccination. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) for focus, perimenopausal. The patient previously received the first dose of bnt162b2 intramuscularly at the right arm on 28Dec2020 at 2:30 PM at the age of 49 years for COVID-19 immunization (Lot number: EL3249). On 15Jan2021, the patient experienced weakness, fatigue, small breathes like slightly short of breath/ short of breath, body aches, low grade fever, abdominal pain one day, all days lymph nodes pain and tenderness especially around the side rib cage and waist area, more on right side then left, neck lymph node aches, feeling really bad like the patient wanted to cry, slight headache, night sweats. Lymph node pain and tenderness is the worse along with body aches and weakness. Also, on 15Jan2021, patient experienced rapid heart rate, increased blood pressure, severe tender and painful lymph nodes-to neck and groin and around sides, under ribs and tenderness to flank area. Mainly right below right ribs and right waist, right flank painful and difficult to turn in bed and lie on right side. There were also Itchiness but no visible rash. According to the reporter the events started on 15Jan2021 at 1AM. The patient received the first dose of bnt162b2 on 28Dec2020 and second dose on 12Jan2021. The patient had nasal swab, rapid on18Jan2021 result was negative and nasal swab on 20Jan2021 result was negative. The vaccine was administered in a hospital. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of the events was recovering except for abdominal pain one day which recovered on 16Jan2021.
49 2021-02-04 blood pressure increased Shot received approx. 11:45 am on 2/3/2021. No I?ll effects besides slight injection site pain in ev... Read more
Shot received approx. 11:45 am on 2/3/2021. No I?ll effects besides slight injection site pain in evening. 6am on 2/4/2021, slight headache, muscle ache, and dizziness. 11am, increased dizziness. 2pm, tiredness, dizziness, increased muscle pain. (2/4/21) 6pm, tiredness, no appetite, fell asleep in chair. 10pm, awoke chilled and with dizziness and went to bed. Woke from sleep with difficulty breathing/catching a breath (2/5/21) and nauseous. 8am, chills, minor breathing issues, elevated temp (98.1) and headache. Slept upright until 1:30pm.
49 2021-02-04 chest discomfort, chest pain discomfort in her chest vs the burning/ chest discomfort; discomfort in her chest vs the burning/whi... Read more
discomfort in her chest vs the burning/ chest discomfort; discomfort in her chest vs the burning/while the chest discomfort had subsided the burning was back; burning in her lungs; coldness/ all over body coldness; fatigue; chills; This is a spontaneous report from a contactable consumer (patient herself, a medical assistant) via Medical Information team. A 49-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EK9231, expiration date: 30Apr2021), via an unspecified route of administration on the right deltoid on 13Jan2021 at 12:30 at a single dose for COVID-19 immunization. The vaccination facility was the clinic. Vaccine was not administered at a military facility. Relevant medical history included sleeping (problem). Concomitant medications included ongoing trazodone as a sleeping pill and an unspecified multivitamin. The patient had no previous immunizations with a Pfizer vaccine as this was the first dose. She had no prior vaccinations within 4 weeks. The patient was having concerns about the side effects was experiencing after her first dose. The patient received the first dose on 13Jan2021 and afterwards she felt fatigue on 13Jan2021; coldness on 14Jan2021 at 07:30; and chills on an unspecified date in Jan2021. On Tuesday, on 19Jan2021, she started having "burning in her lungs" then the day prior reporting, on 20Jan2021 was a vigorous day at work and she had discomfort in her chest versus (vs) the burning." She stated that at the time of the report (21Jan2021), she was working at home and while the chest discomfort had subsided, the burning was back. The patient was asking if this was normal or expected and she didn't call her doctor; she was asking what should she do. The patient further reported that she did have some common side effects and the some of them were the normal ones such as: fatigue, chills, and feeling cold for a few days. The patient further reported that all over body coldness occurred at 7:30 AM on 14Jan2021; she noticed it shortly after she woke up. She actually noticed it after drinking coffee and then it was like the coldness kicked in. It would get worse as she drank things. It did not matter if it was hot or cold things. It was like the hot things intensified the cold feeling. At the time of the report she was having more concerning symptoms. On Tuesday (19Jan2021), she started to have burning in her lungs and the day prior reporting (20Jan2021) at work, she had chest discomfort. It was a little busy day at work running around on the floor. The chest discomfort was nothing significant, but it was a discomfort, especially on the left side. She confirmed she did not have that discomfort at the time of the report. However, she was having the burning again. She was having concerns and wanted to speak to someone about this. She went on to explain she noticed the fatigue during the night on the day she got the vaccine. It resolved around 16Jan2021. She added she had all over body coldness. She confirmed this was the same as the chills and feeling cold. This feeling comes and goes. She added, it was also winter so it was really hard to tell what it was from. The first two days, she had this chills, cold feeling for two days straight. However, at the time of the report it was better. The chest discomfort started the day prior reporting; however, she was doing a lot of activity and she did not have it today. At the time of the report, she was sitting all day working from home. However, the burning was back. The adverse events did not require any visit to an emergency room or a physician office. She stated she thought about calling the doctor's office, but she had not called them yet. She knew they probably won't be able to help or tell her anything. The patient had no investigation assessment and no relevant test. The patient recovered from the event "fatigue" on 16Jan2021; she was recovering from the events "coldness/ all over body coldness and chills," she was not recovered from the event "burning in her lungs," while the outcome of the events "discomfort in her chest vs the burning/ chest discomfort /while the chest discomfort had subsided the burning was back" was unknown.
49 2021-02-05 heart rate increased Left 15 minutes after vaccine. Heart rate increased to 130 and I needed to sit down outside. Heart r... Read more
Left 15 minutes after vaccine. Heart rate increased to 130 and I needed to sit down outside. Heart rate sustained 120 for about an hour and then dropped to 100 before decreasing back down to a normal baseline. Did not report experience to Kaiser because I didn?t know why my heart rate was so rapid.
49 2021-02-05 hypotension pt was vaccinated at work with her 2nd dose on 1/20/21 and began having symptoms on 1/22. pt prese... Read more
pt was vaccinated at work with her 2nd dose on 1/20/21 and began having symptoms on 1/22. pt presented to my office on 1/25/21 she had confusion, memory loss, labial bp, relative hypotension, bradycardia, severe fatigue, muscle pain and weakness, barely able to rise from a chair or walk, also reported HA, diarrhea, hiccups,decreased O2 sat to a low of 91%-her baseline is 98-100%, she developed a rash after her appointment with me.
49 2021-02-06 chest pain I got the 2nd vaccination for Pfizer-BioNTech Covid-19 Vaccine EUA and after i have a Fever, chill, ... Read more
I got the 2nd vaccination for Pfizer-BioNTech Covid-19 Vaccine EUA and after i have a Fever, chill, headache, nauseos and muscle pain where injection is and chest.
49 2021-02-07 chest pain Patient had shortness of breath, stridor, chest pain 10 minutes after 2nd COVID-19 vaccine dose. Rec... Read more
Patient had shortness of breath, stridor, chest pain 10 minutes after 2nd COVID-19 vaccine dose. Received epi-pen, nebulized bronchodilators, steroid injection, diphenhydramine and famotidine. Patient was in ER about 7 hours for observation, improved and was discharged home with supportive care.
49 2021-02-09 hypertension, heart rate increased High heart rate; hypertension; This is a spontaneous report from a contactable pharmacist. A 49-yea... Read more
High heart rate; hypertension; This is a spontaneous report from a contactable pharmacist. A 49-years-old female no pregnant female patient received ,at hospital, the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) from lot# EL3249 on 12Jan2021 at SINGLE DOSE for covid-19 immunisation . Medical history included diabetes mellitus, ongoing hypertension, high cholesterol. Concomitant medication included metformin (METFORMIN), atorvastatin (ATORVASTATIN), hydrochlorothiazide, losartan potassium (LOSARTAN HCTZ). On 13Jan2021 the patient experienced high heart rate and .Lab data included heart rate (13Jan2021): high Outcome of the events was recovering. No Covid prior vaccination, No covid tested post vaccination
49 2021-02-09 excessive bleeding Mild Headache and a rash that started on my lip and spread to my cheek, my eye and forehead. The ras... Read more
Mild Headache and a rash that started on my lip and spread to my cheek, my eye and forehead. The rash it blistery kind of looking, little bit blister and they would open and bleed and then close back up. It was also burning. It start continually spread more. I went yesterday 02/09/2021to a Dermatologist he treated me for a contact kind of dermatitis as if he was unsure if it was linked to vaccine or not. He gave me two steroid injections in the office and prescribed a cream Elidel 1% . The medications seem to be clearing up my face today.
49 2021-02-24 heart rate increased 12/22 vaccination 4pm. 4:05 PM, my HR went way up. I broke out on neck, chest, face; fire engine red... Read more
12/22 vaccination 4pm. 4:05 PM, my HR went way up. I broke out on neck, chest, face; fire engine red. Felt like burning from the inside, out. Lightheaded and dizzy. Got puffy. Was NOT anaphylactic. 2 Benadryl. I didn't feel good for a couple weeks. 14-20 days, same experience with redness/burning. I took pictures. That happened every day for 4-5 more days. I went to doctor after doctor; ER after ER. About 6-7 times I have been to the ER; SOB, dizzy all the time, panic attack/anxiety, Stomach is not emptying correctly (NOT diabetic), eye keeps twitching, hurting behind my eyes, all my muscles are shrunken now. Blood panel, stress test; gastroparesis; positive; ringing in my ears; SOB; *COVID; negative.
49 2021-02-24 chest discomfort Initially, tingling tongue and gums. Tongue felt ?big?. All over body itching. Excessive coughing... Read more
Initially, tingling tongue and gums. Tongue felt ?big?. All over body itching. Excessive coughing. Could not clear throat. It felt as if I was put inside a CS chamber. Went to ER. Treated with steroid and antihistamine. Coughing stopped with residual tightness in chest. Tingly stopped and reduced itchiness.
49 2021-02-24 fainting, hypertension Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Hypert... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Hypertension-Medium
49 2021-02-24 fast heart rate Tachycardia-HR 122, patient refused transport
49 2021-02-25 heart rate increased No side effects with 1st dosage. within 8 hours of 2nd dose side effects included: rapid heart rate... Read more
No side effects with 1st dosage. within 8 hours of 2nd dose side effects included: rapid heart rate, insomnia, body pain, joint pain, lower back pain, severe chills, upset stomach, nausea, headache. Within 36 hours, most of the side effects were gone, except headache. 3 days later - still have headache, and flush feeling all over body with mild sore throat (as of 2/26/21 @ 11:27 a.m.)
49 2021-02-25 platelet count decreased, low platelet count, fainting Received COVID vaccine 1 on 1/13 and COVID vaccine #2 2/1. 49 y/o previously healthy female who had... Read more
Received COVID vaccine 1 on 1/13 and COVID vaccine #2 2/1. 49 y/o previously healthy female who had a COVID 19 exposure ~ 1/3. The person she was exposed to tested positive 1/6 (daughter had a fever and cough). On 1/11 the patient received the 1st dose of the Pfizer vaccine. 12-24 hours after the Pfizer vaccine she developed fevers, malaise, myalgias that lasted 2-3 days (Called off work). She then returned to a normal state of health. On 2/1 she received the second dose of the vaccine. On 2/6 she developed right pleuritic chest pain so went to an urgent care. COVID 19 PCR was positive and CXR unremarkable. She was told to take naproxen and her pleuritic chest pain slowly improved. On 2/8 she started to have general malaise followed by nausea. On 2/11 she developed increased nausea and vomiting followed by diarrhea-eventually that day she had a near syncopal episode prompting her presentation to the hospital. Seen at an outside hospital between 2/11-2/12. CT abd/pelvis showed patchy ground glass opacities at the base of the lungs and she was noted to have diffuse mural thickening. There was concern for possible cholecystitis so a perc cholecystostomy tube was placed. Ultimately she developed significant hypoxic respiratory failure and had to be intubated.She was transferred to another hospital on 2/12. Initially she was started on treatment with dexamethasone but continued to clinically get worse. Also on empiric antibiotics.
49 2021-02-26 palpitations, fast heart rate 15 minutes after injection, I felt whole body flushing with tachycardia and palpitations that lasted... Read more
15 minutes after injection, I felt whole body flushing with tachycardia and palpitations that lasted for 5 minutes. The symptoms resolved and then 15 minutes later, the same symptoms occurred and lasted 10 minutes.
49 2021-02-26 blood pressure increased Throat tingling, flushed, diaphoresis, increased blood pressure to 160's,
49 2021-02-27 chest discomfort 5 min after the shot, throat and chest began to feel slightly tight; nurse monitored for 45 min; no ... Read more
5 min after the shot, throat and chest began to feel slightly tight; nurse monitored for 45 min; no other symptom changes or treatments given; 65 hours later woke up with a swollen face and generalized rash on throat - this is current state at time of submission so final outcome unknown at this time
49 2021-02-28 fast heart rate, fainting Fever 103.0 F, Chills, Muscle Pain, Headache, Night Sweats, Dizziness/near-syncope, tachycardia (120... Read more
Fever 103.0 F, Chills, Muscle Pain, Headache, Night Sweats, Dizziness/near-syncope, tachycardia (120's bpm), nausea, severe fatigue, severe soreness at injection site (but mild swelling, mild itching). Starting from 3:30 am on 02/21/21 until about 3 pm on 02/22/21. Milder headache and fatigue throughout rest of that week. Back to normal now.
49 2021-02-28 fainting patient had swelling of arm and fainted. patient was provided a cold pack for their arm and head/nec... Read more
patient had swelling of arm and fainted. patient was provided a cold pack for their arm and head/neck. symptoms resolved
49 2021-03-03 fast heart rate Dizzy, anxious, tachycardia, nausea
49 2021-03-04 hypertension After receiving the medication, the patient stated that she felt tingling in right arm. She states t... Read more
After receiving the medication, the patient stated that she felt tingling in right arm. She states that she had a headache. It subsided in 20 minutes. Blood Pressure was very high 5:13PM 175/102 P94 O2 100: 5:19 PM 183/109 P96 O2 100 5:23PM 173/101 P99 O2 100 5:53 PM 162/98 P92 O2 99
49 2021-03-07 excessive bleeding Second vax, vax burned when going into arm this time, started feeling tired three hours later. Had a... Read more
Second vax, vax burned when going into arm this time, started feeling tired three hours later. Had a full dinner, went to bed at 10:00. Woke at 4:00 am feeling very achy. Went to kitchen for ibuprofen, took two. Started feeling very nauseated. Went to master bathroom to urinate, and started feeling like I was going to faint. Tried to make it three steps to my small sofa outside bathroom door. That?s the last thing I remember. My husband heard me fall. I had fallen chin first on hardwood floor. He found me lying in a pool of blood. Before going to ER in the next 15 minutes, i had an extreme bout of diarrhea. At ER, I learned that I had Broken both my condyals in jaw and fractured lower mandible. At ER and hospital on 2/2, threw up multiple (about 7-8) times, even with anti-nausea drugs in IV. Doctor put an anti-nausea patch behind my ear but not sure if it helped. Had surgery to set it on 2/3/21.
49 2021-03-08 palpitations hypertensive crisis; mental fog; I had systemic reaction with numbness; tingling; extreme nausea; he... Read more
hypertensive crisis; mental fog; I had systemic reaction with numbness; tingling; extreme nausea; headache; thirst; palpitations; changes to color of extremities; cold/heat intolerance; diuresis; inability to eat; inability to eat or sleep; This is a spontaneous report from a contactable Nurse (patient). A 49-year-old female (not pregnant) patient received BNT162B2 (lot number: ek9231) second dose on 06Jan2021 on left arm at single dose for covid-19 immunization. Medical history included hypothyroidism and allergies to penicillin. Concomitant medications in two weeks included levothyroxine sodium (SYNTHROID), liothyronine, magnesium carbonate (MAG 2), trimebutine maleate (MOTRI), zinc, curcuma longa (CURCUMA). The patient previously took BNT162B2 (lot number: ek5730) first dose on 17Dec2020 10:00 AM (age of vaccination was 49-year-old) on left arm for covid-19 immunization. Facility type vaccine was Hospital. No other vaccine in four weeks. On 10Feb2021 07:00 (also reported as 08Feb2021), approximately one month after 2nd vaccine, patient received a steroid epidural with contrast and a day after she had systemic reaction with numbness, tingling, extreme nausea, headache, thirst, palpitations, hypertensive crisis, changes to color of extremities, cold/heat intolerance, extreme thirst, mental fog, diuresis, inability to eat or sleep. Not sure if related to vaccine. No COVID prior vaccination. COVID tested post vaccination (Nasal Swab, PCR) on 17Feb2021 and result was Negative. The outcome of the event was recovering. AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization]. Hospitalization for 2 days. Patient received symptomatic management as treatment.; Sender's Comments: It is unclear what was the indication for the mentioned 'steroid epidural with contrast ' performed one month after the second dose of BNT162B2. The reported systemic reaction with numbness, tingling, extreme nausea, headache, thirst, palpitations, hypertensive crisis, changes to color of extremities, cold/heat intolerance, extreme thirst, mental fog, diuresis, inability to eat or sleep seems attributable to the reported procedure, or the unspecified indication for the procedure, rather than BNT162B2 vaccine. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
49 2021-03-23 pulmonary embolism She reports having a surgery on 1/4/2021. Received vaccine on 3/5/2021 and went to ED on 3/7/2021 an... Read more
She reports having a surgery on 1/4/2021. Received vaccine on 3/5/2021 and went to ED on 3/7/2021 and diagnosed with bilateral PE's.
49 2021-03-24 fast heart rate she experienced tachycardia (157 BPM); warm sensation in her chest and ears; This is a spontaneous r... Read more
she experienced tachycardia (157 BPM); warm sensation in her chest and ears; This is a spontaneous report from a contactable Other HCP (patient). A 49-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, batch/lot number and expiration date unknown), via an unspecified route of administration on 08Mar2021 at age of 49 years old at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received her first Pfizer Covid vaccine on 08Mar2021. Within 15 minutes she experienced tachycardia (157 BPM) and a warm sensation in her chest and ears. The symptoms resolved in 45 minutes. She would like guidance on if she should receive the second dose. The outcome of events was recovered on 08Mar2021. Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported events of tachycardia due to temporal relationship. Case will be re-assessed upon the additional information provided. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
49 2021-04-09 heart attack, blood clot Blood clot in LAD which caused a STEMI; Blood clot in LAD which caused a STEMI; This is a spontane... Read more
Blood clot in LAD which caused a STEMI; Blood clot in LAD which caused a STEMI; This is a spontaneous report received from a contactable consumer (female). A 49-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6208), first dose via an unspecified route of administration, administered in Arm Left on 20Mar2021 08:15 (at the age of 49 years old), single dose for covid-19 immunisation. Medical history included hypothyroidism, Penicillin allergy, both from an unknown date. The patient was taking unspecified concomitant medications within 2 weeks of vaccination. The patient experienced blood clot in lad which caused a STEMI on an unspecified date (reported as 03Mar2021 15:15, for clarification since before vaccination date). The outcome of the events was unknown. The events was assessed as serious, causing hospitalization, disability and was life-threatening. Treatment for the events were Balloon in LAD / clot buster. The patient underwent lab tests and procedures which included COVID-19: negative on 03Mar2021. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Information on Lot/Batch number was available. Additional information has been requested.
49 2021-04-11 chest discomfort, heart rate increased increased heart rate, chest pressure
49 2021-04-17 hypertension My mouth on the right side droops slightly; feel a wired dizziness that got worse; Blood pressure wa... Read more
My mouth on the right side droops slightly; feel a wired dizziness that got worse; Blood pressure was high; I was disoriented and I could not move my arms or legs; they were not able to understand my speech; I could not move my arms or legs; This is a spontaneous report received from a contactable consumer (patient). A 49-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (brand: Pfizer, lot: ER2613) in right arm on 26Mar2021 08:15 AM at single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was Hospital. Medical history included Graves Disease (in remission), papillary necrosis of kidney, Raynaud's, fibromyalgia, breast cancer survivor. Allergies to medications, food, or other products: Morphine, Sulfa, Aspirin, Ibuprofen, Bactrim, Escitalopram. Patient was not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included ascorbic acid, cobalt sulfate, copper sulfate, ergocalciferol, ferrous fumarate, magnesium sulfate, manganese sulfate, nicotinamide, potassium iodide, pyridoxine hydrochloride, retinol, riboflavin, thiamine hydrochloride, tocopherol, vitamin b12 nos, zinc gluconate (MULTIVITAMIN (16)), gabapentin, tizanidine, paracetamol (TYLENOL). Patient experienced: Less than 10 minutes in the waiting area (reported as 26Mar2021 08:15 AM), began to feel a wired dizziness that got worse and she was able to signal a nurse who was attending to another lady having a reaction in the same seating area. Blood pressure was high, she was disoriented and she could not move her arms or legs. According to the doctor and nurse, they were not able to understand her speech. Her mouth on the right side droops slightly. Patient was admitted on 26Mar2021 and discharged from hospital on 28Mar2021. Events resulted in Emergency room/department or urgent care, Hospitalization. Treatment included testing, IV. Covid test post vaccination on 26Mar2021 (nasal swab) was negative. Prior to vaccination, the patient was not diagnosed with COVID-19. The outcome of the events was unknown. Information on Lot/Batch number was available. Additional information has been requested.
49 2021-04-20 low platelet count microangiopathic hemolytic anemia; thrombocytopenia; severe hyperbilirubinemia/cholestasis with coag... Read more
microangiopathic hemolytic anemia; thrombocytopenia; severe hyperbilirubinemia/cholestasis with coagulopathy; severe hyperbilirubinemia/cholestasis with coagulopathy; severe hyperbilirubinemia/cholestasis with coagulopathy; thrombotic microangiopathy; jaundice; nausea; vomiting; diarrhea; This is a spontaneous report from a contactable physician. A 49-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in Arm Left on 29Mar2021 13:45 (Batch/Lot Number: ER8733) as single dose for covid-19 immunisation. Patient was not pregnant. The COVID-19 vaccine was administered at Doctor's office/urgent care. Medical history included Metastatic breast cancer. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant Therapy included Clinical trial oral drug - ARV-471 on 22Mar2021. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient presented to the hospital on 05Apr2021 complaint of (c/o) 1 week of jaundice, nausea, vomiting, and diarrhea, which started on an unknown date in Mar2021, and on 05Apr2021 found to have evidence of microangiopathic hemolytic anemia, thrombocytopenia, and severe hyperbilirubinemia/cholestasis with coagulopathy. Work-up revealed like thrombotic microangiopathy although etiology unclear. ADAMTS13 level 29 with no inhibitor not suggestive of Thrombotic thrombocytopenic purpura (TTP). Patient eventually died of this acute presentation. She also had a history of metastatic breast cancer and had also just started taking a phase 1/2 oral clinical trial drug ARV-471 on 22Mar2021. Unclear if the drug, COVID vaccine, or breast cancer may have contributed to current illness. Adverse event resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Prolongation of existing hospitalization (vaccine received during existing hospitalization), Life threatening illness (immediate risk of death from the event), Patient died. Patient hospitalized for 5 days. Date of Death was on 09Apr2021. Death cause: Death certificate stated metastatic breast cancer. No autopsy performed. Therapeutic measures were taken as a result of events included plasmapheresis, steroids, antibiotics. The patient underwent lab tests and procedures which included Nasal Swab: negative on 05Apr2021. The outcome of the events was fatal.; Sender's Comments: Based on temporal association and the limited information available, the causal association between BNT162B2 vaccine and the reported events cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: severe hyperbilirubinemia/cholestasis with coagulopathy; jaundice; nausea; vomiting; diarrhea; microangiopathic hemolytic anemia; thrombocytopenia; severe hyperbilirubinemia/cholestasis with coagulopathy; severe hyperbilirubinemia/cholestasis with co
49 2021-04-20 chest pain, heart attack my right leg was still bothering me, It feels a little bloated, so I am walking slower than usual; m... Read more
my right leg was still bothering me, It feels a little bloated, so I am walking slower than usual; my right leg was still bothering me, It feels a little bloated, so I am walking slower than usual; I was afraid I was having a heart attack; Initial hyperactivity; tiredness; chest pains; urge to vomit; body aches all over; This is a spontaneous report received from a contactable consumer (patient herself). A 49-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number was unknown), via an unspecified route of administration in left arm on 01Apr2021 at 16:00 (at the age of 49-year-old) as a single dose for COVID-19 immunization. The patient's medical history included issues with anemia in the past and known allergies: Tree nuts was all that I am aware of (allergies to medications, food, or other products: Tree nuts was all that I am aware of). Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive other vaccine within four weeks of vaccination. The patient did not receive other medications within two weeks of vaccination. Since the vaccination, the patient has not been tested for COVID-19. No COVID prior vaccination. The patient was not tested for COVID post vaccination. It was reported that the, initial hyperactivity on 04Apr2021 (patient think it was the anticipation of the shot), followed by tiredness that evening on 04Apr2021, Friday, Saturday, and Sunday. With the exception of having lunch with a friend on Saturday and stopping by to check on her mom, patient stayed home all weekend because she was feeling very tired. Late Sunday night after going to bed she awoke with chest pains and the urge to vomit on 04Apr2021. Patient was up and down vomiting for several hours and began to experience body aches all over on 04Apr2021. At one point she was afraid she was having a heart attack on 04Apr2021. On Monday morning and throughout the day she was still experiencing body aches and stayed home from the office. Patient slept propped up on the living room sofa Monday night because lying down made her body aches worse. Today, Tuesday 06Apr2021, her right leg was still bothering her, it feels a little bloated, so she was walking slower than usual. Otherwise she feel normal. The events were considered as serious (life threatening, hospitalization) by the consumer. No treatment medications were received for the adverse events. The outcome of the events was recovering. Information on the lot/batch number has been requested.
49 2021-04-23 blood pressure decreased At 09:50 BP 157/98,then 09:51 BP 161/101, At 08:58 am 167/80,At 10:13 BP 181/93, At 10:22, BP 165/98... Read more
At 09:50 BP 157/98,then 09:51 BP 161/101, At 08:58 am 167/80,At 10:13 BP 181/93, At 10:22, BP 165/98,At 10:24 BP 164/102, At 10:27 BP 167/99; Unable to work after the 2nd dose; I wasn't able to go back to work because of severe weakness; Dizzy; my BP went down to 90/60, 80/56; This is a follow-up spontaneous report from a contactable Nurse in response to HCP letter sent in cross referenced case. A 49-years-old female patient received second dose of BNT162B2 (Solution for injection, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EK9231) via an unspecified route of administration in deltoid right on 14Jan2021 at 09:00 (at age of 49 years old) as single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient's historical vaccine included first dose of BNT162B2 (Solution for injection, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EK5730) via an unspecified route of administration on 20Dec2020 as single dose for Covid-19 immunization. On 14Jan2021, the patient was placed on close monitoring after receiving the second dose for continuous pulse oximetry, O2 saturations ranged from 98%-100%. At 09:50 BP 157/98, HR 73, 99% O2 sat, then 09:51 BP 161/101, HR 100, SpO2 100%, at 08:58 am 167/80, HR 85, SpO2 94%. The PCP prescribed clonidine 0.1 mg as needed for SBP>160. The patient took 1 tab clonidine 0.1mg. At 10:13 BP 181/93, HR 63, SPO2 100%, at 10:22, BP 165/98, HR 59, 100% SPO2, at 10:24 BP 164/102, HR 77, 99% SPO2, at 10:27 BP 167/99 HR 74, 100% SPO2. Later the patient took 2nd dose of clonidine 0.1mg and at 10:36 BP 134/86, HR 65, SPO2 100%, at 10:47 BP 124/81, HR 65. The patient was released by employee health nurse. She was dizzy when she got home, her BP went down to 90/60, 80/56. The patient was unable to work after second dose because of severe weakness. The patient stayed in bed for 5 days. The patient went back to work on 19Jan2021. Treatment for the event blood pressure fluctuation was two dose of tab clonidine 0.1mg. The patient provided information regarding the reported adverse events with the use of the suspect product to the nurse and the nurse considered that the Pfizer product had a causal effect to the adverse event. The outcome of the events was unknown. Information on the batch number has been requested.
49 2021-04-24 fainting Feeling Faint; Lightheadedness/dizziness; This is a spontaneous report from a contactable consumer. ... Read more
Feeling Faint; Lightheadedness/dizziness; This is a spontaneous report from a contactable consumer. A 49-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number: EP7533, via an unspecified route of administration, administered in left arm on 07Apr2021 13:00 as single dose for Covid-19 immunisation. Medical history included Crohn's disease, penicillin allergy. The patient was not pregnant at the time of vaccination. On 09Apr2021, the patient experienced feeling faint and lightheadedness/dizziness. No treatment information was provided. The outcome of the event was not recovered.
49 2021-04-24 loss of consciousness Passed Quickly; Severe Dizziness; very weak; Arm Hurt; Chills; This is a spontaneous report from a c... Read more
Passed Quickly; Severe Dizziness; very weak; Arm Hurt; Chills; This is a spontaneous report from a contactable consumer (patient). A 49-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number and expiration date not reported) via an unspecified route of administration on an unspecified date (at 49-years of age) for Covid-19 immunization. Patients medical history and concomitant medications were not reported. She had an allergic reaction to CAT scan contrast dye in the past. It was reported that after the first dose of the vaccine, within several minutes, she felt dizzy and it passed quickly. 4-5 hours later patient got severe dizziness and her family had to walk her to her bed. She was very weak and very dizzy so she laid down. She was dizzy in the morning and then was only mildly dizzy for a number of days. She also had chills and her arm hurt. She stated she saw dizziness at the bottom of the sheet as a more serious reaction and wanted to know if she should get the next dose of the vaccine? Patient also stated she heard that one dose of the vaccine is over 80% effective. No PQC was present. It was reported that patient did a report. Patient was guided to read form PI section 4. Read from Fact sheet under "WHAT ARE THE RISKS OF THE PFIZER-BIONTECH COVID-19 VACCINE?" regarding the description of serious allergic reactions. Referred to HCP for further discussion. PI: LAB-1457-7.0/ Revised: 06Apr2021 Fact sheet: LAB-1451-4.0/ Revised: 06Apr2021. The patient has a question if she is still considered vaccinated with just one dose? Is it 80% effective? Patient was asked to read from attached document. Outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
49 2021-04-24 blood clot, heart attack, cerebrovascular accident she thought she had a blood clot; maybe it is MS (multiple sclerosis); possible septal infarct; weak... Read more
she thought she had a blood clot; maybe it is MS (multiple sclerosis); possible septal infarct; weakness in her left arm; losing her balance; vaccine was given up high on her arm, not 2 fingers down. She thought they had hit bone; less range of movement in her left foot; trouble walking; like someone who had a stroke; numbness; legs felt heavy climbing stairs; immediate pain when needle went all the way in and worse when vaccine went in; pain in shoulder joint; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: Ep6955), dose 1 via an unspecified route of administration, administered in Arm Left on 25Mar2021 18:00 (at the age of 49years) as single dose for Covid-19 immunization. The patient is not pregnant at the time of vaccination. Medical history included anemia that is treated, living kidney donor, gastric bypass in 1999, gallbladder removal, hysterectomy, intussusception x2, migraines, high heart rate, and smoking. Concomitant medications included omeprazole (OMEPRAZOLE), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), and albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]); all taken for an unspecified indication, start and stop date were not reported. The patient previously received Flu vaccine and Tetanus vaccine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient has not been tested for COVID-19 since the vaccination. She got the shot on 25Mar2021 on Thursday evening at 1800. She is 49 years old and has had all the flu shots and tetanus shots. She has never had one hurt so bad. She stated that the vaccine was given up high on her arm, not 2 fingers down. She thought they had hit bone. It was reported that the patient experienced immediate pain when needle went all the way in and worse when vaccine went in. The whole time it hurt really bad and her arm hurt severely for 2 days from 25Mar2021. She still has pain in shoulder joint. That aside wasn't a big deal, it went away even though the joint is sore. The following Monday 29Mar2021 in the evening, her legs felt heavy and she had trouble going up the stairs. Then she had complete numbness of her left leg, from her hip or butt crack to the tip of her toes. It was on the same side she had the shot. It was further reported that the patient's legs felt heavy climbing stairs then she woke Thursday morning with her left leg numb. She couldn't feel herself starting to have a bowel movement because the numbness went all the way up to that area. She went to the ER (emergency room) on Saturday night (03Apr2021) because she was afraid of a blood clot. An ultrasound was done on her left leg, CT of head and neck, and blood work with nothing found. She has numbness and less range of movement in her left foot with trouble walking and have had no improvement with calf being numb. It was further clarified that when she was Easter shopping, there was numbness in her foot was causing her to drag her foot around the store. It was like someone who had a stroke, with slight impairment on one side. Her foot slaps the floor. She doesn't have control of it, she can't flex her foot up and down at all and she has little movement in her toes, even now. When she went to the emergency room, she thought she had a blood clot. She is a kidney donor and is healthy over all except for anemia that gives her tingly toes since she was 30, off and on. She never had a body part felt so numb, other than when she sits on her leg wrong. They did a bunch of tests there. They did a doppler, CT scan, and an EKG (unspecified date) which was abnormal. Her EKG has never been abnormal before. It said possible septal infarct undetermined time. The doppler showed no deep or superficial blockages noted from her groin down to her toes/ankle. The doppler was to check for blood clots. They referred her to her primary care provider who said that she will do a neurological exam. She has weakness in her left arm as well. The weakness in her left arm was only told by the neuro touch test. The patient further clarified that she doesn't have less range of motion, it is really just pain (arm). She can still move her arm all the way. Her left side is weaker or less sensitive as far as the neuro test. She wasn't aware she had less feeling on her arm until the nurse said she did. Her arm pain is nothing significant, it can hurt when moving her arm. She had no leg pain or anything like that until later in the week. She still had symptoms of losing her balance. Getting in and out of the chair she almost fell down. She didn't realize the numbness. Monday, she felt heaviness going up the stairs. For 2 days she had the worst pain ever in her arm. She had the tetanus shot and didn't have anything like that. It went away, when she raises her arm off from the side, she still has pain in the joint. She has migraines, it is nothing that is causing difficulty. She is more concerned something else happened. Patient thought maybe it is MS (multiple sclerosis) and asked if it is peripheral artery disease. She did smoke half a pack every other day. She is 49 but didn't start smoking till she was 36. It is a terrible habit and her doctor is aware. She also had her good and bad cholesterol which was just over 100. She is just reporting it because it happened on only the left side and she is a healthy person. She never had high blood pressure and never been treated for it, but she has had high heart rate before. It is not something that has ever caused any issue. She doesn't have something like peripheral artery disease, when she (software company name withheld) that is said plaque in the arteries. The doppler showed no signs of blockage superficial or deep on that side. She doesn't have an appointment until 29Apr2021. She doesn't know what to do to get more urgent care. The pain in her arm was better after the first 2 days. It is like a tooth ache, a dull ache. It is not all the time, just when moving her arm. Her legs were worse to where Thursday, she woke, and she was numb from the top of her leg to the tip of her toe. She can still lift her leg, but when she walks the tip of her second toe which is longer will drag on the ground. When she walks it is hard to hold her shoe on the left foot or put her shoe on. She can't maneuver her foot. When her foot hits the ground, the ball area of her foot smacks the floor because she doesn't have control over it. It is laboring to walk and is hard. She was kind of limping and pulling that leg on the left side. Her laboratory tests were BMP, CBC auto diff, CBC with diff, CT, angiogram of the head and neck, EKG 12 lead, and they did a venous doppler of the left lower extremity. It all came back good except the EKG which says septal infarct undetermined date, which has never come up on any tests before. The events resulted in Emergency room/department or urgent care, Disability or permanent damage. There was no treatment received for the adverse event. The patient has not been tested for COVID-19 since the vaccination. The outcome of events was not recovered.
49 2021-04-26 blood clot I was diagnosed with a blood clot in my right leg; This is a spontaneous report from a contactable c... Read more
I was diagnosed with a blood clot in my right leg; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in right arm on 03Mar2021 15:45 (Lot Number: EN6202), at the age of 49-years at vaccination, as SINGLE DOSE for covid-19 immunisation. Medical history included none. The patient is not pregnant at the time of vaccination. The patient received dose 1 of the vaccine on 10Feb2021, lot number: EM9810, on 10Feb2021 03:45 PM at right arm. The patient did not have COVID-19 prior vaccination. The patient's concomitant medications were not reported. On 04Mar2021 12:00 AM, patient was diagnosed with a blood clot in her right leg. The event required emergency room visit. The patient was put on Xarelto, a blood thinner for clots. The patient has not been tested for COVID-19 post vaccination. The outcome of the event was unknown.
49 2021-04-27 loss of consciousness This is a spontaneous report from a contactable other healthcare professional (patient). A 49-year-o... Read more
This is a spontaneous report from a contactable other healthcare professional (patient). A 49-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0158 and expiration date not provided), via an unspecified route of administration administered in the right arm on 11Apr2021 14:00 as a single dose for COVID-19 immunization. Medical history included Crohns Disease. The patient is not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient has no known allergies. There were no concomitant medications. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. On 12Apr2021 01:45, about 12 hours after the first dose, the patient passed out and then broke out in a cold sweat, multiple times. No treatment was given in response to the events. The outcome of the events was recovering. The patient has not been tested for COVID post vaccination.; Sender's Comments: Based on the plausible temporal association and product safety profile, the reported events are possibly related to the vaccine BNT162B2. administration. This case will be reassessed upon receipt of additional information. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
49 2021-04-28 chest discomfort, fainting, fast heart rate This is a spontaneous report from a contactable consumer reporting for a patient. A 49-years-old fem... Read more
This is a spontaneous report from a contactable consumer reporting for a patient. A 49-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 09Apr2021 11:00 (Batch/Lot Number: ER8737) as SINGLE DOSE for covid-19 immunisation, at 49 years old at other facility type. The patient is not pregnant at time of vaccination. Medical history included allergies to Rosemary from an unknown date. No other vaccine in four weeks were noted. Patient did not have COVID prior vaccination and was not tested for COVID post vaccination. Concomitant medications included cetirizine hydrochloride (ZYRTEC); propranolol hydrochloride (INDERAL); lorazepam (ATIVAN); hctz; quetiapine fumarate (SEROQUEL); gabapentin taken for an unspecified indication, start and stop date were not reported. The patient previously took macrobid [nitrofurantoin] and experienced allergies. The patient previously received the first dose of BNT162B2 (Lot number: ER8727) on 17Mar2021 13:00 (left arm) for COVID-19 immunisation. On 10 Apr2021, the patient experienced Itchy palms (reported as within hours), tachycardia, tightness in chest, difficulty breathing, tingling tongue and fingers, vomiting, confusion, dizzy, fainting, abdominal pain, severe pain everywhere, too fatigued to move. Patient tried to call ambulance but could not get phone or unlock the door. She stated she tried from 1 AM to 07:30 AM. After 07:30 AM she had expected effects of fever as well as fatigue and pain. The events resulted in Doctor or other healthcare professional office/clinic visit. Treatment was not given. Outcome of the events was recovered on an unspecified date.
49 2021-04-28 fainting positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; Chills; Fatigue; stomach... Read more
positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; Chills; Fatigue; stomach pains; nausea; diarrhea; migraine; dizziness; body aches; faint; This is a spontaneous report from a contactable consumer reporting for self. A 49-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 31Mar2021 10:00 (Batch/Lot number was not reported) at the age of 49 years old, as single dose for covid-19 immunisation. Medical history included allergies to penicillin, codeine, Bactrim, sulfa drugs. Concomitant medications included alprazolam; sumatriptan succinate (IMITREX); amitriptyline. The patient experienced Chills, Fatigue, stomach pains, nausea, diarrhea, migraine, body aches, dizziness, faint from 01Apr2021. Patient visited Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Patient had Nasal Swab on 07Apr2021 with negative result, and on 13Apr2021 with Positive result. Outcome of event COVID-19 virus test positive was unknown, of other events was not recovered. Information about lot/batch number has been requested.
50 2021-01-01 chest discomfort Went to see an urgent care MD that day, he confirmed it was a swollen lymph node. Followed up at my ... Read more
Went to see an urgent care MD that day, he confirmed it was a swollen lymph node. Followed up at my primary care office next week Dec 28th, MD confirmed it was swollen lymph node likely related to immune response to COVID vaccine.
50 2021-01-03 palpitations Had heart palpitations within two hours of vaccine, severe headache, body aches, fatigue and shortne... Read more
Had heart palpitations within two hours of vaccine, severe headache, body aches, fatigue and shortness of breath. Sore left arm all the way down arm. Rested and took ibuprofen. Today I returned to work still having headache
50 2021-01-03 heart rate increased Pfizer-BioNTech COVID-19 Vaccine EUA. Vaccine received at 11:40 AM. At approximately 9pm I began to ... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA. Vaccine received at 11:40 AM. At approximately 9pm I began to experience whole body chills, teeth chattering, and extreme fatigue. I took Ibuprofen and went to sleep. I experienced chills until approx 3 AM. My watch alerted my heart rate rose above 120 bpm three separate times during the night in the 1, 2 and 3:00 hours. Upon review of the summary it appears to have been sustained at just over 120 for that entire time. I awoke at noon, with a temp of approx 99.5 F, I felt extreme fatigue and a sense of cold but body was warm to touch and I was very sweaty this entire time. I slept most of the day and at 5 pm awoke with a temp of 102.4F. I contacted my physician who directed me to use tylenol and Benadryl. I took a dose at 5 pm, anther at 9 PM. Upon waking the next morning I was afebrile. At that time I felt slightly dizzy and lightheaded but also dehydrated. Forcing fluids relieved symptoms. I experienced a very mild headache and very mild queasiness as well.
50 2021-01-03 palpitations dizziness, palpitations and lightheadedness right after vaccination and lasted up to 2 hours
50 2021-01-04 heart rate increased 8:31 Reported to us increased heart rate and tingling lips. Stated she had several allergies and bro... Read more
8:31 Reported to us increased heart rate and tingling lips. Stated she had several allergies and brought her epi pen with her. Brought her to EMS station. 8:32 Gave epi 8:35 HR126 SPO2 100% 8:38 IV placed 8:39 POC 108 8:39 Benadryl 50mg IV push 8:40 Solumedrol 125 mg IV push Continued tongue/throat/ head itching 8:42 second epi given 8:46 136/64 HR 125 8:48 Transported to Medical Center via EMS
50 2021-01-04 heart rate increased, chest discomfort, palpitations After vaccine she felt flushed, heart rate 99 bp 181/105. Sent to ER. She reported chest tightness a... Read more
After vaccine she felt flushed, heart rate 99 bp 181/105. Sent to ER. She reported chest tightness and palpitations while in the ER. Given Benadryl and discharged stable. She reported that her heart rate went up again for a few minutes that night at home and next day and then she was fine.
50 2021-01-04 blood pressure increased, palpitations BP; 170/110 mild SOB palpitation (HR 80bpm) hot flashes mild sweating Took Claritin, increase flui... Read more
BP; 170/110 mild SOB palpitation (HR 80bpm) hot flashes mild sweating Took Claritin, increase fluid intake, and extra Valsartan x 1.
50 2021-01-04 heart rate increased allergic reaction; had been a little sick since she had it; she really felt bad; weak; rash on her l... Read more
allergic reaction; had been a little sick since she had it; she really felt bad; weak; rash on her legs/ rash all over her; Fever/ feverish; a fast heart rate that comes and goes; Hasn't felt good; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration in left arm on 21Dec2020 at single dose for COVID-19 immunization. The relevant medical history and concomitant medications were reported as none. She indicated she received vaccine on 21Dec2020 and noticed a rash on her legs in the shower on 24Dec2020. She hadn't felt good since done on 21Dec2020. She had a rash all over her, didn't realize when went back and read a paper, said a bad rash all over body, what should she do, take a Benadryl. She stated the health department gave the vaccine. She had been a little sick since she had it. Tuesday was really bad, all day on Tuesday, she really felt bad. She woke up with a rash at the time of the report on 24Dec2020, she thought she had a fever, but didn't check, that was last night and this morning, but at the time of the report she didn't think she had a fever. The rash, she was covered in a fine rash all over her body, she had thought it had happened with an allergic reaction immediately. When asked for outcome of not feeling good, stated she felt ok, it was just the rash, that was what she was most concerned about, stated she did have a fast heart rate that comes and goes on 21Dec2020. When she awoke this morning, she was just weak, and feverish, she didn't take her temperature, she should have, but she took a shower a few minutes and saw the rash, thought it was probably all combined. Stated her card said on 11Jan2021, she should take the second dose, and wanted to known should she take it if this is all connected. The patient had tested positive for COVID antibodies on an unspecified date. The outcome of the events "rash on her legs/ rash all over her" and "Fast heart rate" was not recovered, while other events were unknown.
50 2021-01-04 heart rate decreased, blood pressure decreased diaphoretic; woozy; heart rate went down to 43; blood pressure down to 83/57; headache; feeling a bi... Read more
diaphoretic; woozy; heart rate went down to 43; blood pressure down to 83/57; headache; feeling a bit cruddy; This is a spontaneous report from a contactable other healthcare professional. A 50-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: paa156051), via an unspecified route of administration (arm left, dose number 1) on 17Dec2020 10:30 at single dose for COVID-19 immunisation. Medical history included Psoriatic arthritis from an unknown date and unknown if ongoing. Concomitant medication included etanercept (ENBREL), propranolol, and curcuma longa (TURMERIC CURCUMIN). Patient is on unspecified birth control and unspecified vitamins. No other vaccines in four weeks were given. The patient previously took steroids and experienced allergies (similar reaction to steroid 1 year before), and FLONASE and experienced allergies. On 17Dec2020, It was reported that the patient was fine for the first 15 minutes, afterwards became very diaphoretic, woozy, heart rate went down to 43 and blood pressure down to 83/57. The patient recovered enough to leave about 20 minutes. After that, patient's heart rate was back into the 60's and BP stayed the same but the patient was feeling better. Patient's heart rate is usually in the 70's and his BP around 115/75 or so. The patient has no breathing problems. Other than headache and feeling a bit cruddy, the patient has been fine since. Patient mentioned she really wanted to take the second dose, but she does not know if she should. No treatment for the adverse events. No COVID prior vaccination and patient has not tested for COVID post vaccination. Event outcome was recovered on Dec2020. Events were considered non-serious.
50 2021-01-04 chest pain headache, right arm to leg sore, sweating dizzy, hot & cold, want to throw up, loss of appetite, som... Read more
headache, right arm to leg sore, sweating dizzy, hot & cold, want to throw up, loss of appetite, some chest pain, feel woosy, felt confussed right after vaccine,
50 2021-01-05 chest pain Severe Nausea within 30 minutes - has not subsided - still present after 24 hours Chest Pain - began... Read more
Severe Nausea within 30 minutes - has not subsided - still present after 24 hours Chest Pain - began after 10 hours - reduced pain after 24 hours, but still present Headache - began after 8 hours - still present Cough - began after 8 hours - still present Sore Throat - began after 8 hours - still present Shaking hands - began next morning - still present
50 2021-01-05 heart rate increased, fast heart rate Tachycardia/her heart rate at 11:00PM last night was at around 100/ she checked her pulse it was 115... Read more
Tachycardia/her heart rate at 11:00PM last night was at around 100/ she checked her pulse it was 115; she was not feeling right, so she took the day off from work today; Lightheadedness; wobbly; she felt weak; This is a spontaneous report from a contactable nurse (patient). A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL1284, expiration date: Apr2021), via an unspecified route of administration at right deltoid on 29Dec2020 17:45 at a single dose for Covid-19 immunization. Medical history included asthma from 2003 and ongoing, tachycardia and major surgery. Concomitant medication included maintenance inhaler (unspecified) for asthma. Patient was officially diagnosed with asthma in 2003. She said her asthma was controlled, and she takes a maintenance inhaler every day. She said she has been taking the same maintenance inhaler since she was first diagnosed with the asthma. She said she rarely uses a rescue inhaler. Reported she was prescribed the Metoprolol Tartrate 25mg for her tachycardia that she had after her major surgery, but she did not take the full 25mg dose during that time. She said she hasn't had taken the Metoprolol Tartrate 25mg in almost a year, clarifying it was last Jan2020 that she used the Metoprolol Tartrate. The patient previously received a flu shot in Oct2020, and felt rundown for a day afterwards, but that she always does after she receives a flu shot. She said she had no heart issues after receiving the flu shot in Oct2020. The patient who is a registered nurse reported she received the COVID-19 vaccine last night at work, on 29Dec2020, at 5:45PM, and had experienced some tachycardia after receiving the vaccine. Reported the COVID-19 Vaccine was offered through her employer. She said the COVID-19 vaccine was optional and offered to all employees if they work at the hospital. She experienced the tachycardia at 11:00 PM last night, 29Dec2020. She said her normal resting heart rate is between the high 60s to low 70s. She said her heart rate at 11:00PM last night was at around 100, clarifying she was not running a fever at that time. She stated after she received the COVID-19 vaccine, she was not feeling right, so she took the day off from work today, and slept in. She said when she woke up this morning (in Dec2020), she still didn't feel right, saying she felt weak and wobbly, and when she checked her pulse it was 115. She said she does have a past history of tachycardia. She said a year ago she had major surgery, and she had tachycardia after the major surgery. She said the tachycardia eventually went away, but she did have to see a cardiologist and take a beta blocker. She said she took a tiny dose of the beta blocker this morning, and called the cardiologist to let him know what was going on. She said she has not heard back from the cardiologist yet. She said the tachycardia went away once she took the beta blocker this morning. She said she took the beta blocker because her heart rate was going higher, and higher. She said she didn't want to end up like last year after her major surgery with a heart rate in the 170s. She said the tachycardia she was experiencing after receiving the COVID-19 Vaccine was not normal for her. She said once she got over the major surgery last year, her heart rate was fine. Reported her employer was making employees wait around for 15 minutes after the employees received the COVID-19 Vaccine to make sure no one had a major reaction to the COVID-19 Vaccine. She said after she received the COVID-19 Vaccine, she waited around longer than the 15 minutes. She said she felt weird after she received the COVID-19 Vaccine and thought maybe she was experiencing anxiety. She said she was lightheaded on 29Dec2020 after she received the COVID-19 Vaccine and completed a report right then on the website. She said the website is for reporting adverse events, and she was sent a website link to complete the adverse event reporting. She said she signed into the website link while she was still at the hospital. She said one of the website's first questions asked was how she was feeling. She said the question made her wonder if her lightheadedness was due to her heart rate being up because she becomes lightheaded when that happens. She clarified she reported only the lightheadedness on the website, and not the tachycardia. She said her lightheadedness got better and she was fine, and then at 11:00PM the tachycardia hit her like a switch. Reported this morning she felt fine, and then all of sudden she wasn't fine. Tachycardia Treatment: Reported she took a 8.5mg dose, or one quarter of a 25mg tablet (as provided by the reporter) of the beta blocker Metoprolol Tartrate 25mg tablet this morning and called her cardiologist to let him know. She said she split the Metoprolol Tartrate 25mg tablet this morning, and only took a quarter of the 25mg tablet (reported as a 8.5mg dose by the reporter). Reported she believes 100% that her tachycardia was caused by the COVID-19 Vaccine, saying she has been fine up until receiving the COVID-19 Vaccine. She said she got the COVID-19 Vaccine because she was afraid of getting the COVID-19 Virus with her asthma. She said she has no other preexisting conditions besides the asthma. Reported she is not going to get the second COVID-19 Vaccine dose. She said it was scary when her heart rate shot up out of nowhere. She said the COVID-19 Vaccine is the only thing different she has done. She said before the COVID-19 Vaccine, she was completely fine. Patient asked if the Pfizer DSU agent had heard of anyone else who has experienced tachycardia after receiving the COVID-19 Vaccine. The outcome of the event tachycardia was recovered in Dec2020, event lightheadedness was recovering and unknown for the other events. The reporter assessed the event 'tachycardia' as Serious (Medically Significant).; Sender's Comments: Based on the close temporal relationship, the association between the event tachycardia with BNT162b2 can not be fully excluded. The medical history of tachycardia and asthma medication may be contributory as well. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
50 2021-01-05 chest pain, chest discomfort Vaccinated 1510. Observed until 1530. at 1540 it was reported that she had chest tightness. no trou... Read more
Vaccinated 1510. Observed until 1530. at 1540 it was reported that she had chest tightness. no trouble breathing but substernal chest pain 8/10. Vital signs- Temp-97.9 Pulse-95 BP- 162/100 Resp- 22 oxygen saturation- 95 @ room air. 1600- transported to ER for evaluation and treatment.
50 2021-01-06 fast heart rate PATIENT COMPLAINED OF LIGHTHEADEDNESS, VOMITING X2, GAGGING, DROWSY, UNSTABLE, TACHYCARDIC HR 110, B... Read more
PATIENT COMPLAINED OF LIGHTHEADEDNESS, VOMITING X2, GAGGING, DROWSY, UNSTABLE, TACHYCARDIC HR 110, BP 142/91
50 2021-01-06 lightheadedness Pt given 2nd dose of pfizer vaccination given by LVN RN informed that pt was not feeling well at 08... Read more
Pt given 2nd dose of pfizer vaccination given by LVN RN informed that pt was not feeling well at 0834 by LVN. RN informed front desk to call rapid response at 0835. Pt transferred from waiting area to wheel chair then to gurney 0836 vs: bp:151/109 hr:95 02sat: 90 room air- complaint of dizziness, feeling like she is going to pass out, headache 6/10, diaphoretic hands bilaterally, tearful, feeling like she is going to pass out, complaint of congestion, notes she has history of htn and sleep apnea, pt states that she was not feeling well since administration of vaccination however did not inform LVN. 0837:2L o2 via nasal canula 0840: vs: BP 138/75 hr:83 02 sat:94 97.7 temp: on 2L nasal cannula, rapid response arrived report given, pt still feeling the same. 0845: vs bp: 133/84 hr: 79 o2sat: 94 0850: rapid response nurse cleared pt to be discharged, pt given option of going to ED for observation however declined at the time. 0851: pt sat up repeat o2sat: 95 on room air- states that she is feeling better, stating "I think I just have to go home and take a nap" 0855: pt requesting to be discharged, encouraged to have someone drive her home states she will call her sister- pt never picked up phone to call sister- then insisted she is fine to dive herself home. 0856: cleared with -supervisor that pt okay to be wheeled down to car by LVN be wheeled down to car- pt given ed precautions. 0907: LVN reported that pt elected to go to ED as she was experiencing dizziness per LVN. In ED pt given IV Benadryl 25 mg, tordol 15mg iv, 1 liter Lactated ringers, 4 mg Zofran iv
50 2021-01-06 palpitations The patient is a 50 yo female with a history of IBS who reports concerns about Covid vaccine AE. (Pf... Read more
The patient is a 50 yo female with a history of IBS who reports concerns about Covid vaccine AE. (Pfizer EK5730) receipt 16 DEC 2020. She reports no immediate reaction except experienced a dry throat which she noted after her 30 minute wait, but no urticaria, SOB, wheezing, oral/face/throat/tongue edema, flushing, pruritic, CP n/v/d. She states about 3 hours later she developed a dermatitis initially to her legs. The lesions were raised, pink, initially nonpruritic, fixed but no vesicles, pustules or bruising. She took a shower which exacerbated the symptoms with erythematous patches and severe burning sensation. She reports she was seen in ER and her spouse noted lesions to her neck and ears. Her eyes felt swollen. She left ER due to the wait and obtained Benadryl OTC. She saw her PCP in the morning. She received IM dexamethasone and oral prednisone dose pack. She continued to not feel well. She experienced heart palpitations, feeling hot and flushed, fatigue and headache which she treated with Tylenol. She treated the dermatitis with Zyrtec 10-20 mgs q1-2 x daily, but sometimes took Benadryl. Last dose was Benadryl at midnight, Zyrtec 10 at 0600 and has one day of prednisone left. She also experienced bilat tingling in her feet starting day 5. which the left resolved but her right foot continued. She has no paresis, paralysis, altered gait, tripping or fall, difficulty emptying her bladder. She saw PCP on 05 January. ESR was normal . Overall symptoms improved but continued r foot numbness, pain to her legs. She reports PCP ordered CXR and abdominal series which were normal.
50 2021-01-06 chest discomfort feeling close to loss of consciousness; intense chest pressure/tightness; shortness of breath; chill... Read more
feeling close to loss of consciousness; intense chest pressure/tightness; shortness of breath; chills while driving home; This is a spontaneous report from a contactable healthcare professional (patient). A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL0142), via an unspecified route of administration in the left arm, on 02Jan2021 at 11:30 (at the age of 50-years-old) as a single dose for COVID-19 immunization. The patient's medical history was not reported. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications, taken within two weeks of vaccination, included ibuprofen (MANUFACTURER UNKNOWN). The patient previously took amoxicillin (MANUFACTURER UNKNOWN) and experienced allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced feeling close to loss of consciousness, intense chest pressure/tightness, shortness of breath, and chills while driving home on 02Jan2021 at 12:00. The patient did not receive any treatment for the events. The clinical outcome of feeling close to loss of consciousness, intense chest pressure/tightness, shortness of breath, and chills while driving home was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of feeling close to loss of consciousness, intense chest pressure/tightness, shortness of breath cannot be excluded, considering the plausible temporal relationship. The underlying predisposing condition of penicillin allergy may put the patient at high risk of anaphylactic reactions. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
50 2021-01-06 chest discomfort, blood pressure increased patient had Covid 19 vaccine from Pfizer with lot #EJ1686 with expiration date 3/2021 on 1/7/2021 an... Read more
patient had Covid 19 vaccine from Pfizer with lot #EJ1686 with expiration date 3/2021 on 1/7/2021 and after 45 minutes, she came back and stated she has chest tightness, lip swelling, chest congestion, shortness of breath, asthma-like symptoms with mucus type in her chest. her BP at that time was 184/109. She was given 1 EpiPen and 2 Benadryl 25mg tablets.
50 2021-01-06 chest discomfort, blood pressure increased warm, trouble breathing, nausea, chest pressure, arm burning, increased blood pressure Next day f/u... Read more
warm, trouble breathing, nausea, chest pressure, arm burning, increased blood pressure Next day f/u - stick neck, shoulder pain + heat, left cheek swollen been taking tylenol and benadryl saw PCP - received rx for prednisone
50 2021-01-07 chest pain, fibrin d dimer increased On December 25th I had mild chest pain and then on January 1st, 2021 I had severe chest pain that pe... Read more
On December 25th I had mild chest pain and then on January 1st, 2021 I had severe chest pain that persisted and on January 3rd I was admitted into the hospital. My Ddimer was elevated and my Troponin levels were elevated. An angiogram was performed and Dr. injected nitro into my arteries because they were constricted from Coronary Spasms.
50 2021-01-07 chest discomfort, fast heart rate Pt with history of allergic reactions, premedicated w/ Benadryl 50 mg po. 30 min after receiving the... Read more
Pt with history of allergic reactions, premedicated w/ Benadryl 50 mg po. 30 min after receiving the vaccination, she started to have difficulty breathing and chest tightness. No wheezing. Pt had neck and face flushing without hives. Pt tachycardic at 120 bpm. SOB and tachycardia lasted 1.5 hrs. Pt denies anxiety, dizziness or GI symptoms. Pt monitored and advised to avoid 2nd dose of mRNA vaccine; pt declined to see PCP
50 2021-01-07 chest pain, fast heart rate Tachycardia (HR in the 110s), shortness of breath, chest pain 15 min post vax Observation and fluids... Read more
Tachycardia (HR in the 110s), shortness of breath, chest pain 15 min post vax Observation and fluids Sxs resolved after 15 mins of close monitoring NKA
50 2021-01-07 heart rate increased, chest discomfort approx 20 after injection 1420, started getting chills, cold sweat, elevated heart rate, shortness o... Read more
approx 20 after injection 1420, started getting chills, cold sweat, elevated heart rate, shortness of breath and blocky red rash on neck and torso. immediately drove to urgent care, was not allowed in for treatment due to did not have phone on med to call for appointment. went home, took 50 mg benadryl and pepcid po. had tachypnea and continued blocky rash on neck and torso with chest tightness. took albuterol inhaler. approx 0200 had rigors/ seizure. with continued prior symptoms. took additional 50 mg benadryl and albuterol inhaler. temp 99.0. in am 1/6 called urgent care to make appointment thought neded steroid. they said to go to ED. was afraid to go to ED in fear would be intubated as had before for allergic reaction. took additonal 50 mg benadryl, pepcid and zyrtec along with a shot of epi pen. within minutes, all symptoms ressolved. will be calling place where I got vaccinated today to report. 1/8/21
50 2021-01-07 lightheadedness employee felt near syncope[al episode post vaccine administration
50 2021-01-07 pallor sores and redness at the back of throat and tongue; sores and redness at the back of throat and tong... Read more
sores and redness at the back of throat and tongue; sores and redness at the back of throat and tongue; sores and redness at the back of throat and tongue; sores and redness at the back of throat and tongue; numbness; tingling; burning sensation in throat and the back of tongue; burning sensation in throat and the back of tongue; mild nausea; allergic reaction; dizzy, light-headed; ashen pale; head felt heavy; Burning and itchiness on chin persists; Burning and itchiness on chin persists; This is a spontaneous report from a contactable nurse (patient). A 50-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration in left arm on 29Dec2020 12:00 at first single dose for COVID-19 immunization. Medical history reported as none. No known allergies. Concomitant medication the patient received within 2 weeks of vaccination included ergocalciferol (VIT D), linum usitatissimum seed oil (FLAX SEED OIL), cyanocobalamin (VITAMIN B12) and multi-vitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. 2 min after shot the patient was dizzy, light-headed, ashen pale, and head felt heavy. After sitting and lying down about 45 min, the patient felt numbness, tingling, and a burning sensation in throat and the back of tongue. MD took O2 sat (99%) and heart rate (72). The patient felt mild nausea for 5 min. MD gave her Pepcid 20 mg as antihistamine. About 30 min later, the patient noticed sores and redness at the back of throat and tongue. The patient consulted MD and she advised the patient to go to employee health clinic. The clinic MD stated the patient was probably having some kind of allergic reaction to vaccine. The patient was given steroid shot and Benadryl 25 mg PO (per oral) and observed for 90 min. The patient left and was given Medrol Dose pack if symptoms persisted after 2 days. The patient was told to take Benadryl 25 mg PO (per oral) 4-6 hours and Pepcid 20 mg PO (per oral) BID (twice a day) for 1-2 days. Redness, sores at back of throat and tongue persist. Burning and itchiness on chin persists. The patient had no difficulty breathing at any time. Adverse event start date was reported as 29Dec2020 12:15 PM. Events were non-serious. The adverse event result in doctor or other healthcare professional office/clinic visit. Treatment received for the adverse event included: Benadryl 25 mg PO and a steroid shot IM. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the events sores and redness at the back of throat and tongue, burning and itchiness on chin persists not recovered, of other events was recovered with sequel.
50 2021-01-08 palpitations About 15 min after injection my heart started racing and I got lightheaded. Heart rate was 95+ and B... Read more
About 15 min after injection my heart started racing and I got lightheaded. Heart rate was 95+ and BP was 190/90 something. My resting HR is 56 and BP is usually around 120/80. Began to drop after about another 15 minutes. Followed by migraine for the rest of the day. Felt okay when I woke up, but had one episode during the day today in which my heart rate shot up again and was a little short of breath even though I was not exerting myself. Lasted about 10 minutes. Injection site hurts to the touch, but otherwise is painful. Throat hurts a little and a little congested, but probably unrelated.
50 2021-01-08 chest pain Patient was given the first COVID-19 vaccination at approximately 1254 today in her left deltoid. Sh... Read more
Patient was given the first COVID-19 vaccination at approximately 1254 today in her left deltoid. She approached writer at 1310 in no apparent distress. She voiced symptoms that were concerning to her. She indicated about 5 minutes after she received the injection, her tongue felt like it was burning and tingling. She also stated her chest was burning. Denies every having these symptoms ever before. She currently denied shortness of breath, chest pain, shoulder pain, nausea, or throat swelling. No changes in voice were observed by writer. Last time patient ate was between 0930 and 1000 this am. Patient shared that she was feeling anxious about having the vaccine and wonders if this is the reason why she is having the symptoms. Vitals taken, all within normal range.   Patient encouraged to remain for 30 for observation. No further concerns were verbalized to writer during her stay. Patient was encouraged to call 911 if she develops shortness of breath, chest pain, throat swelling or other concerning symptoms after she leaves. Patient verbalized understanding and was agreeable with plan.
50 2021-01-08 chest pain Since administration - Chest pain, Shortness of breath, blurred vision, headache, nausea, and chills
50 2021-01-09 loss of consciousness, hypotension, fainting Chills/shivers, injection site pain, back pain/body aches, nausea, syncope, low blood pressure Start... Read more
Chills/shivers, injection site pain, back pain/body aches, nausea, syncope, low blood pressure Started getting chills at 0300, back pain started and injection arm became very painful. at 0430, got out of bed, nausea became severe and I passed out for 2 minutes. Subsequently fractured my nose from the fall after passing out and ended up in the ER for 6 hours with low blood pressure.
50 2021-01-09 chest pain, chest discomfort STRANGE FEELING IN THROAT AND CHEST THAT PROGRESSED TO CRUSHING CHEST PAIN. CHILLS, BODY ACHES, SOB,... Read more
STRANGE FEELING IN THROAT AND CHEST THAT PROGRESSED TO CRUSHING CHEST PAIN. CHILLS, BODY ACHES, SOB, NAUSEA, RASH. I STILL HAVE SOB AND I DONT KNOW IF IT WILL BE TEMP OR PERMANENT.
50 2021-01-10 blood glucose increased Friday evening 2 hours after dinner my sugar reading was 220. My sugar levels never go over 150 afte... Read more
Friday evening 2 hours after dinner my sugar reading was 220. My sugar levels never go over 150 after a meal. My diabetes is under control
50 2021-01-10 palpitations, hypertension, chest discomfort Received first COVID-19 vaccine Friday 1/8/21 - experienced an episode of palpitations, chest tightn... Read more
Received first COVID-19 vaccine Friday 1/8/21 - experienced an episode of palpitations, chest tightness w/ sob, hypertension, and headache - it subsided that night. Had 2 similar episodes since that time. Seen in ED 1/11/21 for symptoms. Similar episode occured after receiving the Flu vaccine about 3 years ago.
50 2021-01-10 chest pain Right upper chest pain, constant, pain increased with deep breathing, HA
50 2021-01-10 hypertension, chest discomfort fever, chills, sore throat, difficulty swallowing, body aches, joint pain, hypertensive, tightness i... Read more
fever, chills, sore throat, difficulty swallowing, body aches, joint pain, hypertensive, tightness in chest. Went to ER @ Hospital
50 2021-01-10 heart rate increased patient with c/o increased HR and scratchy throat, BP 113/78 HR 130 Pulse Ox 95% on RA, patient resp... Read more
patient with c/o increased HR and scratchy throat, BP 113/78 HR 130 Pulse Ox 95% on RA, patient response called, patient transported to Emergency Department and received Famotidene 20mg IV, Diphenhydramine 50mg IV, Lorazepam 1mg Oral, Ketoralac 15mg IV, one liter normal saline. Observed and discharged home.
50 2021-01-11 palpitations 30 minutes after injection patient experienced flushing of face, sweaty palms and shakiness, jaw tig... Read more
30 minutes after injection patient experienced flushing of face, sweaty palms and shakiness, jaw tightness and nose tingling, heart felt like it was racing. Blood pressure was 150/80 , Pulse 108, respirations 22
50 2021-01-11 haemoglobin decreased Hypokalemia; Hypomagnesemia; Hypocalcemia; Hemoglobin dropped little bit; Tetany; Muscle cramps; Thi... Read more
Hypokalemia; Hypomagnesemia; Hypocalcemia; Hemoglobin dropped little bit; Tetany; Muscle cramps; This is a spontaneous report from a contactable healthcare professional, a physician assistant. A 50-year-old female patient received the first dose of the BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 18Dec2020 (at the age of 50-years-old) as a single dose for COVID-19 immunization. Medical history included tachycardia, tension headache, and glucose tolerance impaired. Concomitant medications included rosuvastatin calcium (CRESTOR), gabapentin (MANUFACTURER UNKNOWN), and metoprolol (MANUFACTURER UNKNOWN). On 18Dec2020, the patient experienced hypokalemia, hypomagnesemia, hypocalcemia, tetany, muscle cramps, and hemoglobin dropped little bit. The clinical course was as follows: The patient received the vaccine and about 30 minutes later she started to "feel bad". She went to the urgent care and about an hour after they took her to the emergency room (also reported as hospital). She had a complete blood count, complete metabolic panel, and magnesium level done on the 18th, 21th, 23rd, 26th, 28th, 30th of Dec2020 and then again on 04Jan2021. On 18Dec2020, her initial lab test showed potassium: 2.6, hemoglobin: 10.2, magnesium: 1.2, and calcium: 5.7. The physician assistant reported that a potassium of 2.6 was critically low and a hemoglobin was 10.2 was about normal for the patient. She received oral medications of potassium 20 mEq twice a day and calcium and magnesium supplements once a day. On 04Jan2021, lab data showed: potassium: 4.2, magnesium: 2.1, calcium: 9.5 and hemoglobin: 14.5. Per the reporting physician assistant, the above levels went back to normal but stated she had to be supplemented to get back to that point. The clinical outcomes of the hypokalemia, hypomagnesemia, hypocalcemia, and hemoglobin dropped little bit were recovered on 04Jan2021; while that of the tetany and muscle cramps, were unknown. The physician assistant assessed the events as related to the suspect vaccine. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
50 2021-01-11 lightheadedness Received 1st dose vaccine and became nauseated, dizzy, lightheaded and almost passed out.
50 2021-01-11 blood pressure increased, heart rate increased, palpitations Received her COVID-19 vaccine. Patient stated "within 10 mins of receiving the vaccine, I started f... Read more
Received her COVID-19 vaccine. Patient stated "within 10 mins of receiving the vaccine, I started feeling like I'm going to have an asthma attack." She reported having headache, chills, her heart racing, "I feel like my airway is closing that I had to cough". Vital signs were taken by staff at the clinic. Patient reported BP was elevated, HR elevated, but O2 Sat was 100%. Within 15 mins symptoms resolved. Patient returned to her work area in the ED that same morning. During her shift she took Motrin for a headache. On 1/8/21, @ 2330 started feeling burning sensation on the injection site, noticed that there was a blister and redness on the area. . 1/11/2021, she reported redness at the injection. All other symptoms resolved on its own.
50 2021-01-11 chest pain Severe nausea; headache; sore throat; sweating with chills; sweating with chills; chest pain; inject... Read more
Severe nausea; headache; sore throat; sweating with chills; sweating with chills; chest pain; injection site soreness; shaking hands; This is a spontaneous report from a contactable other HCP reported for herself. A 50-year-old female patient received first dose of BNT162B2 (lot number: ej1686), via intramuscular in right arm, on 05Jan2021 06:30 AM at single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient hasn't been tested for COVID-19. Medical history included Known allergies: sulfa antibiotics, avascular necrosis, multiple joint replacements, anticoagulation, chronic pain, multiple hospitalizations in 2020 for diverticulitis. Facility where the most recent COVID-19 vaccine was administered was hospital. No other vaccines was received within 4 weeks prior to the COVID vaccine. Concomitant medications which patient received within 2 weeks of vaccination included warfarin, oxycodone, linaclotide (LINZESS), cyanocobalamin (VIT B12), ergocalciferol (VIT D) and iron. The patient experienced severe nausea, headache, sore throat, sweating with chills, chest pain, injection site soreness, shaking hands on 05Jan2021 07:00 AM. The events resulted in doctor or other healthcare professional office/clinic visit. No treatment was received for the events. The outcome of the events was recovering.
50 2021-01-11 chest pain Woke up 1/9/2021 Saturday morning around 0700 with stabbing pain in my left chest/underarm area when... Read more
Woke up 1/9/2021 Saturday morning around 0700 with stabbing pain in my left chest/underarm area whenever I took a deep breath. No other symptoms. No fever no real shortness of breath only when inhaling deep and exhaling. Continued as a dull ache in the background. I was due for my 2nd covid vaccine which I proceeded to get at 1045am on 1/9/2021. The pain continued as a dull ache in the background. I took Ibuprofen 600mg and then later took a Pepcid 20mg. No real change with the pain and by 3:30pm in the afternoon it was starting to get worse so I when to ER. All tests were normal, I was diagnosed with Pleurisy but no cause was identified. Have taken Aleve 2 x a day for 3 days and tylenol as needed. I self scheduled a covid test 1/11/2021 which was negative. on 1/12/2021 I still have mild pain but it has slowly improved but has not resolved as of this date 1/12/21 Still no other symptoms.
50 2021-01-12 palpitations, blood pressure increased My b/p shot up as well 180/107; My heart started racing....noted at 133/I had strong heart palpitati... Read more
My b/p shot up as well 180/107; My heart started racing....noted at 133/I had strong heart palpitations; Feeling of lightheadedness; This is a spontaneous report from a contactable nurse reporting for herself. A 50-years-old female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, via an unspecified route of administration in the right arm on 29Dec2020 at 12:15 pm, at 50-years of age, at single dose for COVID-19 immunization. The patient received the vaccine in Hospital and didn't receive any other vaccine in the previous four weeks. Medical history included hypertension from an unknown date (controlled) and no known allergy. Concomitant medication included amlodipine besilate 10 mg (NORVASC). The patient reported that, on 29Dec2020, within 6 minutes after receiving the vaccine dose, her heart started racing, it was noted at 133, her blood pressure shot up as well to 180/107, she had strong heart palpitations with feeling of lightheadedness. Prior to the vaccine the patient was at work, feeling well and taking care of her patients. Emergency Room visit and Physician Office visit were required, moreover fluids and potassium were administered to the patient as a result of the events. She reported she spent 8 hours in the ER. The events were reported as non-serious but they were assessed as important medical events by the Company. At the time of the report the reported events were resolving. Information about Lot/Batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Hypertensive crisis, Palpitations, and Lightheadedness cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
50 2021-01-13 chest discomfort Shortness of breath, chest tightness, throat itching, ear closing and itching developed 4 hours afte... Read more
Shortness of breath, chest tightness, throat itching, ear closing and itching developed 4 hours after vaccine dose. Treated with inhaler, Claritin, Zyrtec and Benadryl. Symptoms reoccurred every 4 hours x3 and then resolved.
50 2021-01-14 heart rate increased 1/13 10:30am - 2:30pm Extreme Chills 1/13 2:30pm - 1/14 5:00am Fever (102.7 at the high point... Read more
1/13 10:30am - 2:30pm Extreme Chills 1/13 2:30pm - 1/14 5:00am Fever (102.7 at the high point) Shortness of Breath, Increased Heart Rate, Lower Blood Oxygen Levels (down to 92%), Cough 1/14 5:00am - 7:00am Chills 1/14 7:00am - 11:00am Fever, Shortness of Breath, Increased Heart Rate, Lower Blood Oxygen Levels, Cough 1/14 2:00pm - 3:00pm Chills 1/14 3:00pm - 5:00pm Fever, Shortness of Breath, Increased Heart Rate, Lower Blood Oxygen Levels, Cough
50 2021-01-14 blood pressure increased 1340-EE c/o nauseated( with heaves but no emesis), dizziness, with a severe HA. BP 193/83 HR 62 O2 ... Read more
1340-EE c/o nauseated( with heaves but no emesis), dizziness, with a severe HA. BP 193/83 HR 62 O2 88-96%RA; 1345-EE to ED room 14 for further evaluation.
50 2021-01-14 chest pain 2nd dose- Fever, joint pain, severe neck and chest pain for 36 hours
50 2021-01-14 palpitations I woke up at 12:39am feeling nauseous and with a pounding heartbeat. I also had a headache and seve... Read more
I woke up at 12:39am feeling nauseous and with a pounding heartbeat. I also had a headache and severe body aches, and chills, but no fever. I drank some water and sat up in bed for a while. The pounding heartbeat settled down in about half an hour. I did not take Advil or anything else because of the nausea. Later in the morning I had some nasal congestion. Symptoms persisted but slowly waned until 6:00pm that day. After that, fatigue was the only symptom that lasted until about the 48 hour mark.
50 2021-01-14 blood pressure increased, heart rate increased We (myself and 2 other pharmacists) were conducting a COVID-19 vaccine clinic. The patient is on sta... Read more
We (myself and 2 other pharmacists) were conducting a COVID-19 vaccine clinic. The patient is on staff at the clinic and came in for her 1st dose of the Pfizer/BioNTech COVID vaccine. 10 minutes post-vaccination, patient started experiencing SOB, tingling fingers and face, and swelling of her lips and tongue. She moved herself outside to cooler air and then sent someone back inside to ask us for help. I ran outside with an EpiPen and immediately noted her pulse of 158 on her watch and she appeared to be experiencing an anaphylactic reaction. Patient stated she did not want to use the EpiPen but wanted to try chewing Benadryl instead first. I asked the staff for a blood pressure monitor and pulse oximeter. The 1st readings, approximately 12 minutes after vaccination, were HR 158, BP 155/105, and pulse ox 97%. Patient stated the Benadryl was working and her swelling was decreasing. The patient was not having trouble breathing at the time. I continued monitoring vitals and talking with the patient and approximately 20 minutes post-vaccination, she was improving (BP down to 134/80 and HR 120) but agreed we should call 911. She decided she wanted to move inside and lie down. I escorted her with support to a bed. Her vitals then increased again to BP 152/95 and HR 133 and her lips and tongue started swelling again. The patient appeared to be more labored in breathing then but still refused the EpiPen. Roughly 5 minutes after lying down, the medics showed up and took over and I went back to the vaccination area. I learned later that the patient refused to go to the hospital and after more observation was eventually allowed to leave with a friend/coworker driving her home.
50 2021-01-17 blood pressure increased Patient reported shortness of breath and elevated blood pressure
50 2021-01-18 blood pressure increased, hypertension Got vaccine at 11:30am. At 1:30p not feeling right, sweating, anxiousL hand swollen and tight, inj... Read more
Got vaccine at 11:30am. At 1:30p not feeling right, sweating, anxiousL hand swollen and tight, injection site looked normal. Assessed and was given Benadryl 50mg PO and lay down for an hour. Went home at 2:30p. Returned to work the next day and at noon felt feverish (100.0F), SOB, overall muscles ached and sore, injection site sore. My blood pressure was taken x 2 at 200/100 by nursing. I was driven to local ER and worked up. They could not determine if symptoms r/t to vaccine or not. My BP returned to normal. I was given a diagnosis of hypertension and a script for Lisinopril 5mg PO qd. I continue to have fluctuating high BP readings. My left hand swelling resolved. I plan to see my PCP as I have now s
50 2021-01-18 hypertension Received vaccine at 11:30am. At 1:30p didn't feel well, noted that my left hand was swelling and fe... Read more
Received vaccine at 11:30am. At 1:30p didn't feel well, noted that my left hand was swelling and felt tight. The injection site looked OK. I was sweating and face was flushed. I was given Benadryl 50mg PO and lay down for an hour at work. I went home at 2:30p. The following day I went to work but at 12:00noon I was feverish (100.0F), dizzy, SOB, all-over sore muscles and my blood pressure was 200/100 taken twice by nurses at the facility. I was taken to the ER by car and had labs and work up in the ER. They were unable to determine if symptoms were vaccine related or not. I had taken first dose of hypothyroid medication on 1/14/21. They diagnosed hypertension and wrote me a script for Lisinopril 5mg PO daily. I continue to have high BP readings. My left arm at injection site is sore. The edema in my hand resolved the first day after the Benadryl dose.
50 2021-01-18 heart rate increased, heart rate increased rapid heart rate, fever, diarrhea. called in sick to work.
50 2021-01-19 palpitations Palpitation, shortness of breath, dizzy, nausea, headache, pain on injection site
50 2021-01-19 fast heart rate Patient had same symptoms as she did after her first shot: tachycardia, flushed face, feeling ill. ... Read more
Patient had same symptoms as she did after her first shot: tachycardia, flushed face, feeling ill. She was observed for 30 minutes and felt better. Symptoms resolving.
50 2021-01-20 chest discomfort, palpitations #1 Pfizer 12/24/20 w/ chest tightness, DOE starting 4 hrs post vaccine. DOE resolved after 24hrs. Em... Read more
#1 Pfizer 12/24/20 w/ chest tightness, DOE starting 4 hrs post vaccine. DOE resolved after 24hrs. Employee contacted company, who in consult with CDC recommended #2 Pfizer 1/14/21 administered at an allergist's office. Instructed to take Claritin 10mg 1hr prior to appt. At 2hrs post vaccine, patient developed similar sxs of chest tightness, DOE, palpitations, O2 sat 87%. Given Albuterol via nebulizer, additional dose of Claritin10mg. Patient felt better 5-10min after neb. D/c'd home after total 3hr observation. Had mild DOE 1/15 that resolved w/in 24hrs. Also severe HA, BA, fatigue, injx site pain. Felt much better on1/16. Denies hx asthma or atopic dermatitis.
50 2021-01-20 cerebrovascular accident Pt received vaccine and developed HA with left hemianopsia, left upper ext and left lower ext weakne... Read more
Pt received vaccine and developed HA with left hemianopsia, left upper ext and left lower ext weakness. Stroke Code activated at clinic where she works CT head neg TPA administered, transferred to ED for CTA and stroke care CTA neg MRI pending but clinically improved
50 2021-01-20 fast heart rate, pallor, heart rate increased, lightheadedness She report receipt of vaccine and 30-45 minutes later experienced severe headache, nausea, scratchy ... Read more
She report receipt of vaccine and 30-45 minutes later experienced severe headache, nausea, scratchy throat and loss of voice and breathing was 'heavy'. She reports pallor, increased heart rate and near syncope. She denies pruritis, urticaria, flushing, watery eyes, face/tongue or lip swelling, CP, cough. She was seen in ER and treated with zofran, pepcid, solumedrol, monitored and then released. ER records note tachycardia at 107 but otherwise normal VS and exam. .
50 2021-01-21 fast heart rate, palpitations I felt light headed immediately after the vaccine which lasted 15 minutes. At about 8-8:30pm, i felt... Read more
I felt light headed immediately after the vaccine which lasted 15 minutes. At about 8-8:30pm, i felt very fatigued and fell asleep. At about 11pm I experienced tachycardia that lasted one week with some palpations for another week. My hear rate was over 100. On 12-30-20 my heart rate was not coming down, so i called my nurse cardiologist and he gave me a a refill Metoprolol 6.2mg for me to take this medication only if my heart rate was over 100 to take as needed. I only took Metoprolol for one day. My PCP recommended an EKG. Today I still more fatigued than usual.
50 2021-01-21 fast heart rate I felt light headed immediately after the vaccine which lasted 15minutes. At about 8:30pm. felt fat... Read more
I felt light headed immediately after the vaccine which lasted 15minutes. At about 8:30pm. felt fatigued and fell asleep. then about 11:30pm i experienced tachycardia which lasted one week. My hear rate was over 100bpm. The next day on 12-30-20, my hear rate was not coming down and i spoke with my cardiologist nurse and she did a refill for Metoprolol 6.2mg. I was to only take it if my hart rate was over 100bpm.
50 2021-01-22 chest pain Body aches, headache, fever 101-102.2, weakness, shortness of air, severe chest pain
50 2021-01-22 fast heart rate Fever, chills, tachycardia, muscle aches, vomiting, diarrhea. Lasted 24hours, then resolved.
50 2021-01-22 palpitations Within 5 minutes of administration, I experienced increased heart palpitations. To be fair, I exper... Read more
Within 5 minutes of administration, I experienced increased heart palpitations. To be fair, I experienced random, infrequent heart palpitations before getting this vaccine. When the vaccine was given, I noticed that they were more frequent, and lasted for about an hour, then stopped. Each palpitation only lasted a few seconds.
50 2021-01-23 chest discomfort Extreme joint pain, headache, nausea, exhaustion for 48 hours. As of today 1/24/20 im still experien... Read more
Extreme joint pain, headache, nausea, exhaustion for 48 hours. As of today 1/24/20 im still experiencing tightness in my chest and some difficulty breathing, breathing heavily.
50 2021-01-24 chest discomfort, fast heart rate, lightheadedness, hypertension 1st vaccine - hypertension, tachycardia, full body tingling, lightheaded - resolved after 60 minutes... Read more
1st vaccine - hypertension, tachycardia, full body tingling, lightheaded - resolved after 60 minutes of observation 2nd vaccine - within 2 minutes, similar symptoms started but gradually intensified. Additionally, had chest pressure, throat dryness, sensation of needing to breath faster (but not shortness of breath), presyncope, full body shaking (rigors) and hand numbness. Code medic called and wheeled down to ER. Symptoms (all of them) came in waves and intensified further in ER. Given IV solumedrol, benadryl and famotidine. Within a minute of IV meds, all symptoms resolved and felt fine for 15 minutes. The symptoms then returned in similar waves but with less intensity and further apart.
50 2021-01-24 heart rate increased Typical sore arm right away. Next day, I felt something in my throat - like it was a lodged bone. Sh... Read more
Typical sore arm right away. Next day, I felt something in my throat - like it was a lodged bone. Short of breath and my heart was going faster than normal and short exertion. So I took an antihistamine - Allegra; tums; Tylenol; and took Prevacid. It didn't work. I was worried about my heart and that pressure on my throat. I went to my Dr. appt - she was able to get me in at short notice - and she examined me and did blood work and chest x-ray. Gave prednisone and albuterol . She said my lympyh nodes were swollen on my neck. Symptoms have resolved. And on second dose of vaccine I felt fine. But still have irregular heartbeat but I have a cardio appt coming up. I'm wearing heart monitor - Zeo - I mailed that on the 14 of January.
50 2021-01-25 heart rate increased Fever, headache, fatigue, increased heart rate
50 2021-01-25 palpitations Nausea; Headache; Body aches more in the legs; Body aches more in the legs; Low grade fever; Chills;... Read more
Nausea; Headache; Body aches more in the legs; Body aches more in the legs; Low grade fever; Chills; Mild dizziness; Intermittent heart racing; This is a spontaneous report from a contactable nurse (patient). A 50-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), via an unspecified route of administration (right arm) on 11Jan2021 (20:00) at single dose for Covid-19 immunization. The patient received the first dose of COVID 19 vaccine (BNT162B2, lot number: EJ1685), via an unspecified route of administration (left arm) on 21Dec2020 (03:30 PM) at single dose for Covid-19 immunization. The patient's medical history included idiopathic neuropathy to bilateral feet; no known allergies. Concomitant medication included tramadol. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced nausea, headache, body aches more in the legs, low grade fever, chills, mild dizziness, and intermittent heart racing on 12Jan2021 (08:00 AM). There was no treatment received for the adverse events. The outcome of events was recovering. The patient has not been tested for COVID-19 since the vaccination.
50 2021-01-26 hypertension " Pt c/o left arm tighten shortly after receiving vaccine. BP taken. Pt found to be hypertensive 194... Read more
" Pt c/o left arm tighten shortly after receiving vaccine. BP taken. Pt found to be hypertensive 194/91. RRT called @ 1510. Pt BP still high 191/100 HR 100. Pt then taken to ED [1518] to be monitored. "
50 2021-01-26 blood pressure increased, fast heart rate 1st dose on 12/31/2020. Within 5 minutes of vaccine became severely dizzy, became briefly tachycard... Read more
1st dose on 12/31/2020. Within 5 minutes of vaccine became severely dizzy, became briefly tachycardic with diffuse warmth and claminess. EMS was called after it didn't resolve after 20-30 minutes. Blood sugar 123. BP was elevated to high 160's over high 90s. EMS transported me to the ER. 1 liter of fluids given and BP was back to normal. Head CT scan was done and was normal. Dizziness persisted for about 6 hours and I was very tired for the rest of the day with achiness noted in the evening. I was fine by the next day. 2nd dose received on 1/21/21. I had only slight dizziness after that dose and was able to leave after 30 minutes observation time. Was very tired the weekend following vaccine and have had periods of dizziness/nausea since Sunday1/24/2021. I am still feeling dizzy and nauseated 1/27/21 and was encouraged to report possible side effect to the vaccine.
50 2021-01-26 chest discomfort BP 144/98 HR 77 BPM SP02 98% 4L of O2 via nasal cannula. Patient stated she felt dizzy and had mi... Read more
BP 144/98 HR 77 BPM SP02 98% 4L of O2 via nasal cannula. Patient stated she felt dizzy and had mid chest pressure. Not radiating pain and some dizziness. No blurred vision, no nausea. Patient was placed supine and monitored for an elevated blood pressure. first BP was 180/110. HR was 101. Sat at 94% on room air. Had med history of cancer and other conditions. Normal VP baseline is usually low. Vital s taken before 2 EMTs and on-scene doctor. Patient recovered.
50 2021-01-26 chest pain Chest pain after 15 min discharge approximately 20 min after vaccine.
50 2021-01-26 hypertension Extremely high blood pressure and heart rate, dizziness, numbness in my face, lips and tongue, tingl... Read more
Extremely high blood pressure and heart rate, dizziness, numbness in my face, lips and tongue, tingling and numbness in my fingers I subsequently chewed three Benadryl tablets; symptoms began to resolve after about 1.5 hrs; fully resolved approximately 48 hours later
50 2021-01-26 pallor Tingling lips; Swollen lips; myalgia; joint pain; tachypnic; headache; Weakness generalized; Nausea;... Read more
Tingling lips; Swollen lips; myalgia; joint pain; tachypnic; headache; Weakness generalized; Nausea; she said she was really pale, so much so, that her husband was scared for her; This is a spontaneous report from a contactable other HCP. A 50-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), intramuscular in left deltoid on 22Dec2020 07:00 at a single dose for covid-19 immunization. Vaccination was done in a hospital. There were no relevant medical history and concomitant medications. On to 22Dec2020, she said she feels like she has had a severe reaction to the COVID-19 Vaccine, saying she was not doing so great. Reported she received her first COVID-19 Vaccine dose on 22Dec2020 at 7:00AM in her left Deltoid. She said she had a reaction after receiving the first dose of the COVID- 19 Vaccine. She said her lips were tingling slightly, clarifying her lips were swollen too. She said she took some Benadryl (she clarified she did not have the Benadryl NDC/UPC, Lot or Expiration Date), and the Benadryl took away the lip tingling and swelling. She said she was tachypneic, and developed muscle pains (clarified as myalgia), joint pain, severe headache, weakness, and nausea. She said she also was really pale, so much so, that her husband was scared for her. She said the symptoms lasted for about 3 days, but the weakness lasted longer. Reported she took some Zofran disintegrating tablets for her nausea. Clarified she did have a PCR COVID-19 Virus test after she developed symptoms from receiving the first COVID-19 Vaccine dose. She said she had the PCR COVID-19 Virus test about 3 weeks ago, Dec2020 and the test was negative. She said she thought she had the COVID-19 Virus after receiving the first COVID- 19 Vaccine dose because no one else she knew who had the COVID-19 Vaccine had any issues. The outcome of the events joint pain,. myalgia, tachypnic, headache, pale and nausea was recovered on an unknown date in Dec2020; the outcome of the event tingling lips and swollen lips was recovered on 22Dec2020; while the outcome of weakness was unknown. The events were assessed as medically significant and causality was reported as related.; Sender's Comments: Based on the close compatible temporal association, there was a reasonable possibility that the events were related to the vaccination with BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
50 2021-01-26 blood pressure increased dizziness started 9 days later. Treatment-ER visit and discharged nonspecific. outcome: continues t... Read more
dizziness started 9 days later. Treatment-ER visit and discharged nonspecific. outcome: continues to work does not interfere with ADL. History of hypertension, BP elevated at ER visit. Dizzy episodes last for 2-3 minutes.
50 2021-01-26 pallor, chest pain involuntary muscle contractions in her diaphragm; chills; cold; severe body aches; Involuntary muscl... Read more
involuntary muscle contractions in her diaphragm; chills; cold; severe body aches; Involuntary muscle cramping; chest pain; Feels bad; severe joint aches; tremor; nausea; severe body pain in her back and knees; severe body pain in her back and knees; Weakness; Headache; This is a spontaneous report from a contactable Other HCP reported for self. This 50-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 12Jan2021 07:00 on Deltoid Left at single dose (Lot # EK9231) for covid-19 immunisation. Concomitant medications were none. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 22Dec2020 via Intramuscular at age of 50 years old on Deltoid, Left at single dose (Lot # EH9899) for covid-19 immunisation, experienced Tingling lips, Swollen lips, and the Benadryl took away the lip tingling and swelling, Tachypnea, Myalgia, Joint pain, severe headache, Weakness generalized, Nausea, she said she was really pale, so much so, that her husband was scared for her. She said the symptoms lasted for about 3 days, but the weakness lasted longer. Reported she took some Zofran disintegrating tablets for her nausea. Clarified she did have a PCR COVID-19 Virus test after she developed symptoms from receiving the first COVID-19 Vaccine dose. She said she had the PCR COVID-19 Virus test about 3 weeks ago and the test was negative. She said she thought she had the COVID-19 Virus after receiving the first COVID19 Vaccine dose because no one else she knew who had the COVID-19 Vaccine had any issues. Reported she received the second COVID-19 Vaccine dose on 12Jan2021 at 7:00AM in the left Deltoid. She said the adverse reaction she experienced after the second vaccine dose was slightly different from what she experienced with the first dose. She said about 10 hours after the COVID-19 Vaccine was administered, clarifying at around 17:00PM 12Jan2021, she started having severe body aches(disability), and involuntary muscle cramping (disability), like tetanus. She said even her diaphragm was cramping. She said she had chest pain on 12Jan2021(disability), tremors on 12Jan2021 (medically significant), and body aches, but doesn't think she had fever. She said the symptoms are still going on like with the first COVID-19 Vaccine dose, but she has more severe joint aching on 12Jan2021 (disability), weakness on 12Jan2021 (disability), and nausea on 12Jan2021 (medically significant). She said her knees feel like she was beaten severely. She said she aches so bad, it hurts having pants on. She said she does not have a headache or tremors now, but did have a headache on 12Jan2021 (medically significant) and tremors in the beginning. She said she feels the most pain in her back and knees. She said she feels really bad on 12Jan2021(disability). After the second dose on 12Jan2021, she reports severe body pain in her back and knees (disability). She reports almost feeling like she has tetanus- involuntary muscle contractions in her diaphragm on unknown date(disability), tremor, cold, chills, nausea, muscle cramps/chest pain. 'Felt like a heart attack. It was out of this world'. She still has nausea, severe pain all over my body, she can't be touched, and even wearing pants hurts. She said she is a healthy person with no chronic disease. She said she had nothing wrong with her prior to getting the COVID-19 Vaccine. Reported she hurts so bad, she can't even lift her arm. She completed a covid 19 PCR test after the first dose in Dec2020, which was negative. Treatment were received for the events severe body pain in her back and knees, involuntary muscle contractions in her diaphragm, tremor, nausea, muscle cramping, chest pain, Feels bad, more severe joint aching, severe body aches, Weakness, headache, chills, cold. Reported she has taken 1500mg of Motrin. Outcome of the severe body aches, Involuntary muscle cramping, Chest pain, severe joint aches, weakness, Nausea, Back pain, Knee pain, Feels bad was not recovered. Outcome of the event Tremor was recovered in Jan2021, Headache was recovered.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the reported events cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
50 2021-01-26 hypotension lightheadness, dizziness, & hypotension
50 2021-01-27 chest pain, pallor Customer received FIRST COVID-19 vaccine at 1015 in medical center and transferred to post vaccine o... Read more
Customer received FIRST COVID-19 vaccine at 1015 in medical center and transferred to post vaccine observation. At 1035 customer called out to provider. Customer reports feeling acute nausea and she states she feels as if she is going to throw up. She appears slightly pale and significantly anxious. Customer is moved to ante room, closer to emergency supplies. Customer denies feeling SOB, difficulty breathing or tongue/throat swelling. Reports feeling sweaty, with waves of nausea and intermittent ULQ pain that she describes as sharp and bandlike across the diaphragm. She episodically calls out in pain and clutches her left chest below her ribs stating that it feels better when she puts pressure at the site. Customer admits to having significant anxiety and a history of panic attacks. HR 102, 02 99%. Lungs CTA. Customer accepts Benadryl 50mg PO @ 1043. Customer monitored at site. Over the course of the next 15 minutes, she reports feeling better and more relaxed. Customer reports full resolution of symptoms @ 1100. BP 108/82, P 101, O2 100% RA, RR 16. Customer is agreeable to extended monitoring after receiving Benadryl. She has been driven to the vaccination site by a family member and states she will not be alone at home. She is instructed to watch for progressive s/sx of reaction including increase in throat symptoms, swelling, itching/rash, SOB, chest pain or any other symptoms that are outside her baseline. Instructed to contact EMS for transport to ED. Customer instructed to contact PCP Team prior to next vaccine appointment to discuss post vaccine course and discuss risks/benefits and/or pre-treatments prior to next vaccine. Customer agrees with plan and denies further questions/concerns. Customer released from site at 1115, ambulating independently with steady gait, no obvious s/sx of distress.
50 2021-01-27 cardiac arrest Got booster shot on Wednesday the 20th, came home and was fatigued. Thursday had horrible headache t... Read more
Got booster shot on Wednesday the 20th, came home and was fatigued. Thursday had horrible headache that would not be relieved with tylenol. I took a plane and arrived at 1130 pm. I went to bed shortly after arriving at my daughters house. Friday morning, I was unable to be woken up and my daughter called 911. I was in a coma. I suffered cardiac arrest during a CT to check for clots. I was resuscitated and put on life support. CT scan for clots, strokes, heart attacks were all clear. I was admitted to the C-ICU and on life support, on the ventilator, and was on 3 different medications at max dosage to keep my blood pressure barely surviving. The doctors told my daughter not to expect me to survive because they had no idea why I was suddenly so ill. A doctor then told my daughter that my kidneys were failing, and my liver was damaged. I also developed a high fever and had a high white blood cell count. They gave me Vancomycin and another antibiotic, and then the next the day a kidney doctor gave me lasix to flush out all of the excess fluid. I woke up on Saturday not knowing what had happened and was completely terrified and confused. My daughter was allowed into the ICU to see me and keep me calm, thankfully. She explained to me what happened. I am still in the hospital, as they are keeping me for observation and trying to determine if my kidneys will start working properly again. Prior to this, I have only ever had a kidney infection, and I thought before I might have had the start of a UTI. I do have chronic high blood pressure as well, a long term side effect from open heart surgery 10 years prior for an aneurysm, but aside from that I am relatively healthy 50 year old.
50 2021-01-27 fast heart rate, blood pressure increased Nausea; Blood pressure elevated; Tachycardia; Vomiting; This is a spontaneous report from a contacta... Read more
Nausea; Blood pressure elevated; Tachycardia; Vomiting; This is a spontaneous report from a contactable consumer. A 50-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular from 23Dec2020 11:30 to 23Dec2020 11:30 and from 13Jan2021 13:30 to 13Jan2021 13:30 both intramuscular arm right at SINGLE DOSE for covid-19 immunisation. Medical history included migraine from Feb2015 and ongoing. There were no concomitant medications. The patient stated that she has chronic migraines and takes medications to keep her at a level where she can function. She was on them prior to taking this and did not think they were relevant. She was diagnosed in Feb2015. On 23Dec2020 at 12:00, the patient experienced nausea, blood pressure elevated, tachycardia and vomiting. The patient also stated that she had the same symptoms of events on her second dose. Outcome of the events was recovering. Information on the lot/batch number has been requested.
50 2021-01-27 chest discomfort feeling tight in my lungs; feel tired; spacy; body aches; my limbs felt heavy; gastrointestinal issu... Read more
feeling tight in my lungs; feel tired; spacy; body aches; my limbs felt heavy; gastrointestinal issues; nausea; This is a spontaneous report from a contactable healthcare professional (patient). A 50-year-old female patient received the second dose of BNT162B2 (lot number: Ek4176), via an unspecified route of administration on 13Jan2021 08:00 in right arm at single dose for COVID-19 immunization. Medical history included asthma, thyroid cancer, thyroidectomy, attention deficit hyperactivity disorder (ADHD), and known allergies: Penicillin. Concomitant medications included levothyroxine sodium (SYNTHROID), paracetamol (TYLENOL), salbutamol (ALBUTEROL HFA), budesonide/formoterol fumarate (SYMBICORT), and tiotropium bromide (SPIRIVA). The patient previously took azithromycin (ZPACK), and benzonatate and experienced drug allergy, and first dose of BNT162B2 (lot number: EJ1685) on 23Dec2020 08:00 in arm for COVID-19 immunization. The patient experienced feeling tight in lungs 45 min after on 13Jan2021 09:00, it lasted approximately 30 minutes. Around 3-4 hours after started to feel tired, spacy and body aches. Her limbs felt heavy, and gastrointestinal issues, nausea (ondansetron (ZOFRAN) took care of that issue) no vomiting on 13Jan2021, was brought home from work. And slept for 3 hours. Woke up and have continued body aches. The patient underwent lab tests and procedures which included nasal swab: negative on 04Jan2021. Therapeutic measures were taken as a result of nausea. Outcome of event body aches was not resolved and of other events was unknown.
50 2021-01-28 blood pressure increased 10:50am shot was given, 11am patient started to get cold and having a headache, 11:10am patient star... Read more
10:50am shot was given, 11am patient started to get cold and having a headache, 11:10am patient started to have hard time breathing and severely cold and BP was rising. 911 was called and patient was transported to hospital where she was admitted.
50 2021-01-28 fast heart rate 28 minutes after accination, SOB mild dizziness with tachycardia. resolved after 15-20 min lying dow... Read more
28 minutes after accination, SOB mild dizziness with tachycardia. resolved after 15-20 min lying down.
50 2021-01-28 palpitations Heart palpitations; sore throat; hurt when vaccination was injected; This is a spontaneous report re... Read more
Heart palpitations; sore throat; hurt when vaccination was injected; This is a spontaneous report received from a contactable other healthcare professional (who is also the patient). A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249, expiry date: unknown), intramuscular in the left arm, on 15Jan2021 16:15, at single dose, for COVID-19 immunization, in a public health clinic. The patient medical history and concomitant medications were not reported. Past drug included sulfamethoxazole, trimethoprim (BACTRIM) which the patient has allergies to. The patient did not have COVID-19 prior to vaccination and is not pregnant. The patient did not receive other vaccines in four weeks. The patient experienced heart palpitations, sore throat, and hurt when vaccination was injected on 15Jan2021 at 16:15. No treatment was given for the events. The patient was not tested for COVID-19 post vaccination. The outcome of the events was recovered on an unspecified date.
50 2021-01-28 chest discomfort, loss of consciousness, fainting SOB with chest tightness and syncope episode with loss of consciousness. c/o elephant sitting on the... Read more
SOB with chest tightness and syncope episode with loss of consciousness. c/o elephant sitting on the chest. O2 92%, BP 160/ 90, AED no shock advised. EMS arrived and transported to ED
50 2021-01-28 hypertension Starting one day after the vaccine, I developed a headache which turned into a migraine within 24 ho... Read more
Starting one day after the vaccine, I developed a headache which turned into a migraine within 24 hours. The migraine became debilitating on Sunday, January 3, 2021. I had vomiting, nausea and dizziness as well. I was unable to work on Monday, January 4, 2021 because I still had the migraine. I take Ubrelvy (prn) and it did not work. I attempted to return to work Tuesday afternoon as the migraine subsided, but it returned shortly after I made it to work. Our treatment nurse took my blood pressure, it was high. My blood sugar was high. I was dehydrated and the migraine was back. My nurse practitioner treated me with an IV of saline solution, pain relieving injection for the migraine and Zofran for the nausea.
50 2021-01-28 heart rate increased Woke up next morning with low grade fever, elevated heart rate, body aches, and sizable painful lump... Read more
Woke up next morning with low grade fever, elevated heart rate, body aches, and sizable painful lump swelling under arm that I got the shot in. Low grade fever resolved with motrin. Heart remained elevated for almost 48 hours. My resting heart rate is in the upper 50's. It was in the 90's during this time. Lump (swelling) under arm is getting smaller but still noticeably there 3 days later.
50 2021-01-28 hypertension, heart rate increased pt states that within 10 minutes after vax that she experienced cool tingling sensation down both le... Read more
pt states that within 10 minutes after vax that she experienced cool tingling sensation down both legs below knees and had a rapid heart beat. Pt discussed her symptoms w/ medic at facility when she noticed a tingling at the top of her head and her top lip that was numb and hot. They checked her blood pressure and it was high at that time 153/? Pt was from out of town so transported to Urgent Care via ambulance. Her blood pressure was 170/? at this time. They did an EKG which was normal. Pt was given Benadryl. Dr. told her she had a Panic Attack and issued Hydroxyzine 25mg. Pt. said she has had panic attack before and it wasn't the same but she thinks it may have been from anxiety but is trying to determine what went wrong. Pt is waiting for her PCP to do tele visit for a FU.
50 2021-01-29 hypertension This is a female with a history of breast cancer on tamoxifen, hypertension, asthma who apparently r... Read more
This is a female with a history of breast cancer on tamoxifen, hypertension, asthma who apparently received her second dose of Covid Pfizer vaccine 10 to 15 minutes prior to presentation who presented in ED with complaints of shortness of breath and tingling sensation over her face and neck. Apparently had rash over the first dose and now presented with shortness of breath. She denies any fever chills. No chest pain. EPINEPHrine (EPIPEN) injection syringe 0.3 mg (0.3 mg intramuscular Given 1/26/21 1547) sodium chloride 0.9 % bolus 1,000 mL (1,000 mL intravenous New Bag 1/26/21 1555) dexAMETHasone (DECADRON) vial 6 mg (6 mg intravenous Given 1/26/21 1548) diphenhydrAMINE (BENADRYL) injection 25 mg (25 mg intravenous Given 1/26/21 1548) famotidine (PEPCID) injection 20 mg (20 mg intravenous Given 1/26/21 1548)
50 2021-01-30 loss of consciousness Woke up at 3 am with body aches-got up to take ibuprofen. When I was heading back to bed, my husband... Read more
Woke up at 3 am with body aches-got up to take ibuprofen. When I was heading back to bed, my husband heard a loud thud and found me laying on the floor beside the bed, passed out. He rushed over to me and called my name several times before I became conscious. He estimates it was a span of about 30 seconds. When I awoke, I immediately began to cold sweat and dry heave several times. Then I became cold and was shivering. My husband then transported me to the hospital emergency room. I received a cardiac test, which they said was good. I also received intravenous fluids and medication to treat pain and nausea. They drew labs which they said looked normal and did an X-ray my right shoulder because I struck my head and shoulder on a night stand when I passed out. They released me about an hour later after having me stand and walk to ensure my blood pressure did not drop, causing me to feel faint again. They sent me home with a prescription for Zofran to help with any further nausea, advised me to take ibuprofen for head and shoulder pain and body aches and advised rest. They also said to return if any other incidents occur and to follow up with my family doctor if symptoms persist.
50 2021-02-03 fainting, pallor Client received vaccine at 1:25 pm. After approximately 15 minutes client reported feeling nausea.... Read more
Client received vaccine at 1:25 pm. After approximately 15 minutes client reported feeling nausea. Instructed to stay for an additional 15 minutes for extended observation. Approximately 25 minutes after vaccination client feeling faint and described feeling of acid reflux, difficulty recognizing people and disoriented. Also pale, not clammy. assisted to supine position. EMTs onsite and doctor notified. Nausea continued. Vomited x 2. After approximately 60 minutes client was able to sit up. Spouse arrived and accompanied patient out of the building. Patient ambulated with limited assistance by her husband. Husband given recommendations on follow-up, if needed.
50 2021-02-03 blood pressure increased Patient here for her 2nd Pfizer vaccine. Immediately after she got it, she began to have moderate/... Read more
Patient here for her 2nd Pfizer vaccine. Immediately after she got it, she began to have moderate/severe nausea. She is also having light headedness. Her vitals are 136/90, P-98, O2- 98 @ 1447. She denies history of vaccine allergic reactions. Her only reaction from 1st injection was a sore arm. Her baseline vitals are 121/?, P-60-70. @1452 vitals are 134/88, P-122, o2-99. No meds have been given. Patient given ice pack for neck and reclined in reclining chair. Dr. consulted. Vitals @ 1510 130/70, P-106, 24 resp. Dr. advised further monitoring for the mean time. TC to patient's manager, that patient is having reaction to vaccine and is being monitored and will be delayed in returning to dept. Manager verbalized understanding and appreciation. (Created on 2/04/2021 and 3:42pm) Vitals @ 1553 147/80, P-98. Patient reported that nausea is still the same but that her throat started feeling funny. 50mg Benadryl IM given in Right Deltoid by RN @1600. Dr. informed. Director and AD also informed of situation. Patient's manager called by RN to give update on patient and to request that someone in dept bring patient's handbag. (Created on 2/04/2021 and 4:21pm) Vitals @ 1620 139/86, P-86, O2-97, Resp- 28. Patient reports that strange feeling in throat is improving. Nausea & light headedness is the same. She said that she had been feeling hot earlier but not anymore. Updated Dr. on patient's status. Asked Dr. if she may be released to go home with her aunt who is picking her up at 5pm if patient is stable and her vitals are stable. Dr. stated that patient may be released with a Benadryl tablet to go. (Created on 2/04/2021 and 4:43pm) Vitals @ 1720 163/96, P-114, O2-100 Called IMT to PFW 4. Patient initially refused to be taken to ER. Noticed that patient was having labored breathing. Vitals @ 1739 162/91, P-124. After IMT team spoke with patient about vitals, patient decided to go to ER. Patient was taken in wheelchair by IMT team@ 1745.
50 2021-02-04 heart rate increased, fast heart rate, fibrin d dimer increased, haemoglobin decreased ED COURSE / MEDICAL DECISION MAKING / TREATMENT PLAN: ED Course and Medical Decision Making: Patient... Read more
ED COURSE / MEDICAL DECISION MAKING / TREATMENT PLAN: ED Course and Medical Decision Making: Patient evaluated. Peripheral IV established labs obtained. I do have concern for adverse reaction secondary to the vaccine as her symptoms started she said shortly before an hour after receiving the vaccine is started with tingling in her tongue throat and her body. She has minimal cardiac risk factors. Given she was tachycardic she cannot be perked out. EKG obtained showed no acute ischemic ST elevation or depression. Initial troponin was not elevated. Patient received 500 mL bolus of normal saline she deceived Benadryl and part of Pepcid. While the Benadryl infusion was going on patient reported feeling lightheaded and her heart rate was noted to increase to the 130s briefly. The medications were stopped, the Benadryl had already finished however the Pepcid was not completed. Her heart rate proved quickly and the lightheadedness resolved. Repeat EKG obtained did show some mild ST depression inferiorly. A repeat troponin obtained at 2 hours remain negative D-dimer was elevated to 91 therefore CTA chest was obtained. This showed no evidence of pulmonary embolism there is small groundglass opacity left upper lobe which is likely related to atelectasis do not feel that this is infectious in etiology patient has not had cough fever or chills. She remained on cardiac monitor here without any further tachycardia and her symptoms had resolved. I do believe patient's presentation is secondary to adverse reaction to the vaccination. She was advised to take Benadryl at home and may also try over-the-counter Pepcid at home for her symptoms. Did not feel that steroids were warranted at this time. She is to follow-up closely with her primary care provider. I did advise if she has new or worsening symptoms she should return to the emergency department and she expressed understanding and agreement with this plan.
50 2021-02-05 palpitations Body aches, chills, heart racing, anxiety, fidgety-took Aleve lasted 2 days
50 2021-02-05 chest discomfort Chest tightness, difficulty breathing, dizziness
50 2021-02-07 heart rate increased, heart rate irregular Shivering uncontrollably; Fever; Heart rate was erratic; dysautonomia; High heart rate; patient rece... Read more
Shivering uncontrollably; Fever; Heart rate was erratic; dysautonomia; High heart rate; patient received bnt162b2 with concomitant medication prednisone; patient received bnt162b2 with concomitant medication prednisone; Stomach ache; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient (non-pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Jan2021 11:00 am at single dose at left arm for COVID-19 immunisation. Medical history included penicillin allergy, nonspecific myositis, small fiber neuropathy, stroke, neurogenic orthostatic hypotension, hypermobile EDS, osteoarthritis, osteoporosis, Raynauds, esophageal dysmotility from an unknown date. Concomitant medications within 2 weeks of vaccination included fexofenadine hydrochloride (ALLEGRA), gabapentin, prednisone (PREDNISON), tramadol. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. On same day after vaccination on 21Jan2021, patient had bad stomach ache. Woke up next day shivering uncontrollably, fever of 102 on 22Jan2021 07:45 am. Also heart rate was erratic (patient had dysautonomia) - 140 then dropped to 53 then back up to 123 all in same minute. This happened repeatedly and maintaining high heart rate. Patient didn't receive treatment for events. The adverse events resulted in emergency room/department or urgent care. Outcome of above events was not recovered. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient had not been tested for COVID-19. The report was considered as non-serious. Information on the lot/batch number has been requested.
50 2021-02-08 palpitations, heart rate increased hot, sweaty, sick. could not get out of bed. Weak rest of day. following week-between 10a and 12p, g... Read more
hot, sweaty, sick. could not get out of bed. Weak rest of day. following week-between 10a and 12p, got really hot, heart beat really fast. 1/24-sitting on couch doing nothing, watching TV, chilling. Heart rate was between 106-110. Saw doctor, next day. All was fine. If happens again-do Holter 2/05, and echocardiogram 2/25. Holter-wear monitor for 2 wks. Current sx? just gets episodes-gets really hot, heart beats really fast, palpitations, chills, then ends. This is not all the time. 2/01/2021 ED-SVT. very intermittent, not concerned. do tests that doctor ordered. She has cont to work thru this.
50 2021-02-09 nosebleed Nosebleed that would not stop for over 4 hours, went to ED and INR was 9.43. Usual INR is 2.5. Dis... Read more
Nosebleed that would not stop for over 4 hours, went to ED and INR was 9.43. Usual INR is 2.5. Discontinued Warfarin for 4 days, had INR rechecked on 2/3 it was 1.9.
50 2021-02-10 lightheadedness, fast heart rate, palpitations, heart rate irregular felt near syncopal; very short of breath; heart was pounding hard; felt tachycardic; BP was 160/100;... Read more
felt near syncopal; very short of breath; heart was pounding hard; felt tachycardic; BP was 160/100; irregular HR with PVCs; HR 40; This is a spontaneous report from a contactable healthcare professional (patient). A 50-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number EL1283) on 25Jan2021 08:15 given intramuscular (left arm) single dose for COVID-19 immunization. Medical history included was reported as none. The patient was not pregnant at the time of vaccination. Concomitant medication included estradiol, testosterone, lorazepam (ATIVAN). The patient previously received ultram/ Zofran ad experienced drug allergies, and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL1284) on 04Jan2021 08:15 intramuscular single dose for COVID-19 immunization. The patient was not diagnosed with covid prior vaccination and the patient was not tested for covid post vaccination. On 25Jan2021 at 08:45 AM, 30 minutes after injection,-the patient felt horrible described as her heart was pounding hard and felt tachycardic. BP was 160/100 and HR 110 and felt near syncopal. Then PVCs started/ very short of breath, and HR went from 112, 69, 40, then 80. The patient went to ER. The patient was monitored and given was IVFs and O2, and labs checked. The patient was discharged 7 hours later and continued having irregular HR with PVCs. Outcome of the events was recovering at the time of the report.; Sender's Comments: Based on the available information, a possible contribution of the drug to the event syncope cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
50 2021-02-14 palpitations Severe headaches; Heart palpitations; Severe joint pain/ right shoulder pain; Tremors to hands; Pain... Read more
Severe headaches; Heart palpitations; Severe joint pain/ right shoulder pain; Tremors to hands; Pain in feet; Chronic neck and right shoulder pain/mid upper back; Chronic neck and right shoulder pain/mid upper back; Severe sweats from lung region up-censation of passing out; Severe nerve pain; Insomnia; This is a spontaneous report from a contactable nurse reported for herself. A 50-years-old female patient (non pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular at left arm on 13Jan2021 at single dose for COVID -19 immunization. Medical history included allergies to morphine,demerol, codiene, dilaudid, golytle, adhesive tape. Concomitant medication included flecainide (FLECAINIDE). The patient received any other vaccines within 4 weeks prior to the COVID vaccine: product was GSK (as reported, lot number: hs75g) first dose, on 30Nov2020, in left arm. The historical vaccine included the first dose of BNT162B2 for COVID-19 immunization on 23Dec2020 and experienced severe headache, lethargy, severe body aches, high fevers, COVID positive. The patient experienced severe headaches, heart palpatations, severe joint pain, tremors to hands, pain in feet, chronic neck and r shoulder pain/mid upper back, severe sweats from lung region up-censation of passing out, severe nerve pain, insomnia in Jan2021. It was reported as serious report, seriousness criteria was disabling/incapacitating. The adverse events result in doctor or other healthcare professional office/clinic visit. The events outcome was not recovered. Information on the lot/batch number has been requested.
50 2021-02-21 chest discomfort, chest pain Patient complained of upper left chest pressure, pain, and shortness of breath when walking back fro... Read more
Patient complained of upper left chest pressure, pain, and shortness of breath when walking back from bathroom after receiving 2nd dose of vaccine. Patient had been waiting in waiting area and her time was almost up. Patient's vital signs were taken by EMS and bilateral lung sounds were clear and equal. Pulses bilateral radial were normal. Patient was taken by ER in wheelchair. In ED, patient was given IV Benadryl, Solumedrol, Ativan, pepcid, and Normal Saline infusion for acute bronchospasm. Patient improved and was discharged on same day from ER.
50 2021-02-22 hypotension, heart rate increased Arm burning from the inside out from injection site right after injection; headache; tingling hand a... Read more
Arm burning from the inside out from injection site right after injection; headache; tingling hand and feet; swelling hands feet and face; swelling face; flushed; red all over wheel down to ED; lump in throat; Low blood pressure; high resting heart rate; This is a spontaneous report from a contactable healthcare professional (patient). A 50-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: e10140), via an unspecified route of administration at the left arm on 11Jan2021 09:15 at single dose for COVID-19 immunization. Medical history included psoriatic arthritis, and allergies to shellfish, sulfa, bees, and, kiwi. The patient was not pregnant at the time of vaccination. Concomitant medication included naproxen sodium (ALEVE) and estradiol (ESTROGEN). The patient previously took naproxen (NAPROSYN) and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced arm burning from the inside out from injection site right after injection on 11Jan2021 9:15. Seconds later the patient experienced headache, lump in throat, tingling hand and feet, swelling hands, feet, and face, flushed, red all over wheel down to Ed, low blood pressure, and high resting heart rate all on 11Jan2021. The events resulted in emergency room/department or urgent care. Treatment was received for the all the events reported as IV with added therapy. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The patient had not recovered from the events.; Sender's Comments: Based on the information currently available and due to a plausible temporal relationship, a possible contribution of the suspect product administration to the reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
50 2021-02-22 excessive bleeding, platelet count decreased Pt got vaccine 12/23/2020- then herpes zoster 1/7/2021 so started Valtrex. Started bleeding 1/10/21 ... Read more
Pt got vaccine 12/23/2020- then herpes zoster 1/7/2021 so started Valtrex. Started bleeding 1/10/21 and was admitted with platelet count of zero 1/11/2021. Diagnosed with ITP and is responding to prednisone. Also got IVIG. Of note- her dad has a h/o ITP as well and was on Rituxan and also developed low platelet count with each of his COVID vaccines.
50 2021-02-23 hypertension Headache; Temperature 99 - 101 F; tiredness; higher blood pressure then usual (140 X 82); administra... Read more
Headache; Temperature 99 - 101 F; tiredness; higher blood pressure then usual (140 X 82); administration date=02Feb2021, dose number=2/administration date=20Jan2021, dose number=1; This is a spontaneous report from a contactable consumer. A 50-year-old female patient received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3247) on her right arm, via an unspecified route of administration on 02Feb2021 10:30 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 20Jan2021 (first dose) for covid-19 immunization. The patient experienced Headache, Temperature 99 - 101 F, tiredness, higher blood pressure than usual (140/82); all on 03Feb2021 06:00 AM. Patient received Ibuprofen 200 as treatment for the events. The outcome of the events was recovered on unspecified dates.
50 2021-02-23 blood clot blood clot; This is a spontaneous report from a contactable consumer. A 6-decade-old female patient ... Read more
blood clot; This is a spontaneous report from a contactable consumer. A 6-decade-old female patient (in her 50's) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at a single dose as vaccine. Medical history and concomitant medications were not reported. It was noted that one of the reporter's co-worker developed a blood clot after receiving the first dose of the Pfizer vaccine on an unspecified date. Any information or data on someone developing blood clots? The outcome of the event was unknown. Information on the lot/batch number has been requested.
50 2021-02-26 fainting Dizziness, that turned into a Syncopal event, resulting in a fall, that resulted in a broken ankle a... Read more
Dizziness, that turned into a Syncopal event, resulting in a fall, that resulted in a broken ankle and concussion. Transported to nearest hospital, I had to have emergency surgery on left ankle, by Dr. A plate and screws were placed in my ankle to stabilize the break. I am being treated and monitored by my general doctor for the concussion. I am currently non-weight bearing on my ankle, for a minimum of 2-4 weeks. I am unable to work due to the ankle break and concussion, for an undetermined amount of time. I am scheduled to meet with Dr. on the 4th of March, at which time he stated he will want to begin physical therapy, once the break has reached an adequate stage of healing. I will be re-evaluated by my general Dr. for the concussion in 2 weeks.
50 2021-02-28 fast heart rate Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: All... Read more
Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Chills-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Tachycardia-Medium
50 2021-02-28 palpitations, heart rate increased, hypertension her legs kind of felt like they do when her legs go to sleep; anxiety; heart palpitations; high bloo... Read more
her legs kind of felt like they do when her legs go to sleep; anxiety; heart palpitations; high blood pressure; possible allergic reation; a cool, tingling sensation in her legs; a cool, tingling sensation in her legs; Heart rate increased; she numbness in her top lip; she had a tingling at the top of her head; This is a spontaneous report from a contactable consumer (patient). This 50-year-old female patient female received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EL9262 and expiration date May2021, right arm on 25Jan2021 Administered between 16:00-16:15 PM as single dose (at the age of 50 years) for Covid-19 Immunization. No medical history reported, and no concomitant medication reported. Historical vaccine included BNT162B2 for Covid-19 Immunization. Medical history included Retinitis pigmentosa from 2016, and breast cancer in Dec2015, she is in remission. Went through chemotherapy and reconstructive therapy. She has a family history of breast cancer. Additionally, patient has history of panic attack, supplementation therapy and eye disorder vitamin (she saw her eye doctor in Dec2020, and he recommended she start taking the eye vitamin. She said she started the eye vitamin in the end of Dec2020). The patient has historical vaccine information including flu vaccine Sep2020. Concomitant medication includes lysine;zinc (LYSINE;ZINC) as supplementation therapy from Dec2020 and ongoing, xantofyl, zeaxanthin, (LUTEIN-ZEAXANTHIN), as eye vitamin Dec2020, ascorbic acid (VIT C), acetylsalicylic acid (baby aspirin) and probiotics (PROBIOTICS). The patient experienced a cool, tingling sensation in her legs on 25Jan2021 with outcome of recovered on 25Jan2021 (treatment received), heart rate increased on 25Jan2021 with outcome of recovered on 25Jan2021 (She said she thought maybe her rapid heart rate was from her nerves because she was getting her first COVID-19 Vaccine dose), she numbness in her top lip on 25Jan2021 with outcome of recovered on 25Jan2021 (treatment received), she had a tingling at the top of her head on 25Jan2021 with outcome of recovered, her legs kind of felt like they do when her legs go to sleep on an unspecified date with outcome of unknown, anxiety on an unspecified date with outcome of unknown, heart palpitations on an unspecified date with outcome of unknown, high blood pressure on an unspecified date with outcome of recovered. She said the nurse suggested she talk to a medic located in the back are of where the COVID-19 Vaccines were being administered. She said she talked to medic. She said at that point it was probably about 25 minutes after she received the COVID-19 Vaccine. She said she never had allergies, and had no problem with the flu vaccine. She said she has had issues with anesthesia in the past, and if she is given the wrong type of anesthesia, she can get nauseous. She said the medic took her heart rate, and her heart rate was 154-ish. She said her heart rate was high, but sometimes for her, that is the case. She said the medic asked her how her breathing was. She said her breathing was OK, and could swallow fine. She said when the medic rechecked her heart rate, her heart rate was still the same. The medic said she has two things he can do: she can go to get Benadryl, or she can get checked out by a doctor. She said she wanted to see a doctor. She said she was brought to an Urgent Care to see a doctor. She said her heart rate was still elevated. She said the urgent care staff did a finger prick test (clarified as a blood sugar finger stick test), and she was told the finger prick test was fine. She said the doctor did an EKG, and her EKG was fine. She said the Urgent Care doctor eventually gave her Benadryl. She said after she took the Benadryl, her top lip was not numb, and her legs were fine. She said that was about 3 hours after receiving the COVID-19 Vaccine. She said the doctor felt she had a panic attack. She said she has had one panic attack in the past, and knows what a panic attack feels like. She said she maybe had some anxiety. She said her symptoms didn't seem like a panic attack because she wasn't having difficulty breathing and she wasn't short of breath, but she was somewhat nervous. She said she was not sure what to do, so she contacted her family doctor to see what she should do when she goes for her second COVID-19 Vaccine dose. She said the Urgent Care doctor gave her a prescription for Hydroxyzine Pamoate 25mg capsule, 1 capsule three times daily, as needed, for anxiety. She said her doctor told her the Hydroxyzine Pamoate is used for allergic reactions, as well. She clarified when she was at the urgent care her heart rate went down, and the nurse at the urgent care gave her 2 Benadryl pink capsules. Reported she took Benadryl when she got home because she was afraid she was having an allergic reaction to the COVID-19 Vaccine. Outcome of possible allergic reaction was unknown. She said she had a great night sleep, and the next morning took her first dose of the Hydroxyzine Pamoate 25mg. She said her primary care doctor suggested she take the Hydroxyzine Pamoate 25mg an hour before she gets the second COVID-19 Vaccine dose. The patient underwent lab tests and procedures which included blood sugar finger stick test: 117 on 25Jan2021, electrocardiogram: normal on 25Jan2021 said the doctor did an EKG, and her EKG was fine, heart rate: 154-ish on said her heart rate was high. She said her heart rate was still elevated. Therapeutic measures were taken as a result of a cool, tingling sensation in her legs, she numbness in her top lip, she had a tingling at the top of her head.
50 2021-03-01 loss of consciousness, pallor almost blacked out; Dizzy; sweating; turned very pale; This is a spontaneous report from a contactab... Read more
almost blacked out; Dizzy; sweating; turned very pale; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number: LE9267, expiration date unknown) via an unspecified route of administration in the left arm on 13Feb2021, 09:45AM (at 50 years old) at a single dose for COVID-19 immunization. The patient was not pregnant when vaccinated in Other Vaccination Facility Type. Medical history included high blood pressure and allergies to Biaxin and Amoxicillin; all from an unknown date and unknown if ongoing. Concomitant medications included calcium, lisinopril, colecalciferol (VITAMIN D) which were received within 2 weeks of vaccination. At 50 years old, the patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number: EL1283, expiration date unknown) via an unspecified route of administration in the left arm on 23Jan2021, 09:00AM at a single dose for COVID-19 immunization. The patient was not diagnosed with COVID prior to vaccination, did not receive any other vaccines within 4 weeks prior to BNT162B2, and was not tested for COVID post vaccination. On 14Feb2021 09:45, the patient experienced dizzy, sweating, turned very pale, and almost blacked out. No therapeutic measures were taken as a result of the adverse events. The patient recovered from the events on an unspecified date.
50 2021-03-02 chest discomfort, blood pressure increased, heart rate increased, palpitations Patient was feeling anxious prior to vaccination. As soon as she received her shot she developed mil... Read more
Patient was feeling anxious prior to vaccination. As soon as she received her shot she developed mild chest pressure and palpitations. She was brought to the medical tent for evaluation. Her initial blood pressure and heart rate were both mildly elevated (BP 164/97, HR 101). She had an EKG which showed normal sinus rhythm with no ischemic changes. After 10 minutes of observation her symptoms had resolved and her vitals were improved (BP 137/98, HR 86). She was advised that typical chest pain evaluation includes blood tests that can only be done in ER to definitively rule out ACS, and offered transport to ER, but she felt better and declined, stated she would go to ER if symptoms return.
50 2021-03-02 palpitations Vaccine was given at 12:45pm. At 3:45pm my heart started racing at 180 bmp and didn't stop till I t... Read more
Vaccine was given at 12:45pm. At 3:45pm my heart started racing at 180 bmp and didn't stop till I took 80mg of Betapace four hours later. Heart returned to normal rhythm at 9:15pm.
50 2021-03-03 fainting Scratchy, dizzy, rash, faint
50 2021-03-03 fainting, pallor funny taste in mouth, felt buzzed, headache, confused, tunnel vision, pale, fainted, rash on torso
50 2021-03-03 oxygen saturation decreased nausea, hot flashes, aches, blood pressure drops and spikes, low oxygen, dizziness symptoms subsided... Read more
nausea, hot flashes, aches, blood pressure drops and spikes, low oxygen, dizziness symptoms subsided with antihistamine lasted 2 hours
50 2021-03-04 chest discomfort After receiving her vaccine client complained of pressure in her chest. Vital signs obtained by EMS... Read more
After receiving her vaccine client complained of pressure in her chest. Vital signs obtained by EMS. BP 162/106, HR 82, O2 Sat 99%. Client states she feels better. Client discharged home by EMS.
50 2021-03-04 fast heart rate Within 3 minutes of injection, my pulse became tachycardia, my throat and tongue started to swell. I... Read more
Within 3 minutes of injection, my pulse became tachycardia, my throat and tongue started to swell. I started to cough. It never progressed beyond that. I felt well enough to leave after the 15 min observation period. When I got home, I took 25mg Benadryl.
50 2021-03-19 pulmonary embolism, blood clot, heart rate increased 10 days after my second shot of the Covid vaccine, I was short of breath and my heart rate was eleva... Read more
10 days after my second shot of the Covid vaccine, I was short of breath and my heart rate was elevated. I went to the hospital and they found blood clots in both lungs and I had to be hospitalized.
50 2021-03-21 loss of consciousness, hypotension, chest pain collapse; respiratory distress; hypotension; tongue swelling; throat tightness; blood pressure abnor... Read more
collapse; respiratory distress; hypotension; tongue swelling; throat tightness; blood pressure abnormality; chest pain; increased swelling; skin changes; This is a spontaneous report from a non-contactable other hcp. A 50-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: EN6205), via an unspecified route of administration on an unspecified date) at SINGLE DOSE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. During her 15 minute waiting period after the injection, the patient began to experience throat tightness. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality, chest pain, collapse, hypotension, increased swelling, rapid progression of symptoms, respiratory distress, skin changes and tongue swelling. Treatment included: antihistamines. Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.; Sender's Comments: A contributory role of vaccine BNT162B2 to the reported events cannot be excluded based on the plausible temporal relationship and product safety profile. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ehics Committees, and Investigators, as appropriate.
50 2021-03-22 blood pressure increased, palpitations 4 to 5 hours post vaccination I began to get very dizzy or "woozy", had a pounding heart sensation, ... Read more
4 to 5 hours post vaccination I began to get very dizzy or "woozy", had a pounding heart sensation, felt very "clammy", and had general ague upon any type of exertion such as walking a very short distance using my rolling walker device. This happened 3 times in approximately 2 hours on the day of vaccination. The next day (03/05/21) my blood pressure and heart rate were very elevated (BP 174/111, Heart Rate 168); I went to the emergency room where they were unable to lower my heart rate but sent me home anyway. 03/7/21 I went to ER, where I was diagnosed with atrial flutter and admitted. The atrial flutter was corrected via cardioversion and I was released 3/9/21; I was prescribed Multaq 400mg, 2X/day and take it faithfully.
50 2021-03-24 chest discomfort Everything started with heaviness in the arm, Headache, changes in the skin pigmentation, dizziness,... Read more
Everything started with heaviness in the arm, Headache, changes in the skin pigmentation, dizziness, chest pressure, shortness of breath, extreme tiredness. Everyday passing I was feeling worse, adding radical mood swings. Today March the 25/2021 I am still with taste loss, with chills, with the mood swings (the ones that had me partially hospitalized), the skin pigmentation changes is not the same, and tiredness.
50 2021-03-25 haemoglobin decreased 03/24/2021: Patient presented and was admitted through emergency room for CC of melena. stated that ... Read more
03/24/2021: Patient presented and was admitted through emergency room for CC of melena. stated that she had a BM and had bright red blood at the end. The patient does have a history of peptic ulcer disease and GI bleed. She was admitted last year with GI bleed and was found to have multiple ulcers in the duodenum. Pertinent labs on admission - Initial H&H was 8.9 and 29.6. Repeat H&H 3 hours later?was 7.8 and 24.8. Per the EUA, hospitalizations are to be reported irrespective to attribution to vaccine
50 2021-03-28 palpitations couldn't breathe or drive; heart throbbing in chest for a few minutes - very scary; front right rib ... Read more
couldn't breathe or drive; heart throbbing in chest for a few minutes - very scary; front right rib popped out; lack of appetite; swelling at back of neck/ entire upper body swelled up; intestines gurgling; headache/severe headache; Swelling in rib cage, collar bone; This is a spontaneous report from a contactable consumer (patient herself). A 50-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL9261, expiration date was unknown), via an unspecified route of administration, administered in the left arm on 12Feb2021 at 12:00 as a single dose for COVID-19 immunization. The vaccination facility type was reported as the public health clinic/facility. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1283, expiration date was unknown) on 22Jan2021 at 12:00 PM in the left arm at the age of 50 years, for COVID-19 immunization. Relevant medical history included Graves' disease from an unknown date and unknown if ongoing and had her thyroid removed on an unspecified date. Concomitant medications included levothyroxine sodium (LEVOTHYROXINE) for Graves' disease as she had her thyroid removed; levothyroxine sodium (SYNTHROID) for Graves' disease as she had her thyroid removed; and doxycycline taken for an unspecified indication; all start and stop date were not reported. The patient previously took codeine and had known allergy to this drug. The patient was not pregnant at the time of vaccination. The patient had no other vaccine in four weeks. The patient had no Covid prior vaccination. The patient was not tested for Covid post vaccination. On 27Feb2021 at 06:00, the patient experienced swelling at back of neck, intestines gurgling, and headache. On 28Feb2021, the patient's entire upper body swelled up and her front right rib popped out; she had severe headache, lack of appetite, and slept sitting straight up as she could not put pressure on spine or lay down. On 01Mar2021, the patient's spouse took the patient to a chiropractor to adjust rib as she couldn't breathe or drive. Six (6) hours later on 01Mar2021, the patient experienced heart throbbing in chest for a few minutes - very scary. Swelling in rib cage, collar bone from an unspecified date in on Feb2021, and neck were subsiding by 11 pm. On 03Mar2021, the patient had her second chiropractic (chiro) visit to adjust neck. On 13Mar2021, gastronol was given for gurgling and the patient still had no appetite. The swelling was all better. The patient would need to go to the chiropractor about four more times to keep adjusting rib back in place. The adverse events (AE) resulted in a doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of all the events, which included chiropractic care for rib adjustment and gastronol. The patient recovered from the events "swelling at back of neck/ entire upper body swelled up and swelling in rib cage, collar bone" on an unspecified date, while the patient was not recovered from the rest of the events.
50 2021-03-28 hypertension shooting up high blood pressure after Pfizer vaccine almost immediately after getting the vaccine in... Read more
shooting up high blood pressure after Pfizer vaccine almost immediately after getting the vaccine in my right arm, less than five minutes. I felt a flush go down my left arm; shooting up high blood pressure after Pfizer vaccine almost immediately after getting the vaccine in my right arm, less than five minutes. I felt a flush go down my left arm; got extreme pain all the way down to the tips of my fingers; slight tingling in the fingertips; could not move my arm; nausea; dizziness; bone pain in arms and legs; exhaustion; My arm still hurts; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration at the age of 50-years-old, administered in Arm Right on 05Mar2021 11:00 (Lot Number: EN6205) as single dose for COVID-19 immunization. Medical history included allergies to walnuts. The patient was not pregnant. The patient's concomitant medication included High blood pressure medication. The patient previously took Niacin and experienced allergies. The patient reported, "shooting up high blood pressure after Pfizer vaccine almost immediately after getting the vaccine in my right arm, less than five minutes. I felt a flush go down my left arm, starting at the top of my shoulder down to my hand and got extreme pain all the way down to the tips of my fingers with slight tingling in the fingertips. I could not move my arm, blood pressure shot up to 200 then it was 192/121 and so on I was monitored at the hospital for a couple of hours with no change or help. I went home and monitored for 29 hours it stayed elevated in the upper hundreds, spiking lowering down a few to 174/124 and spiking back up I got the vaccine on Friday at 11:00 AM my blood pressure did not break until Saturday around 3:00 p.m. I got other side effects, nausea, dizziness, bone pain in arms and legs, exhaustion but the blood pressure scared me the most. My arm still hurts to this day 12Mar2021. I was evaluated but not given anything to bring it down." The adverse events started on 05Mar2021 11:00 AM. The events resulted in Emergency room/department or urgent care, Prolongation of existing hospitalization (vaccine received during existing hospitalization). No treatment for adverse events were received. The patient underwent lab tests and procedures which included blood pressure measurement: high, up to 200 then it was 192/121 on 05Mar2021 spiking lowering down a few to 174/124 on Mar2021. The patient recovered with lasting effects. Facility type vaccine was Hospital. No other vaccine in four weeks. Not diagnosed with COVID prior vaccination. Not COVID tested post vaccination.
50 2021-03-29 deep vein blood clot Pt received second dose of COVID vaccine at hospital on 2/19 (date given by pt). Pt had been more s... Read more
Pt received second dose of COVID vaccine at hospital on 2/19 (date given by pt). Pt had been more sedentary than usual due to winter season. As weather warmed and pt became more active, she began to experience symptoms of left lower extremity DVT on 3/15. Pt evaluated at urgent care on 3/19 and was sent to medical center for follow up. Lower extremity dopplers were negative for DVT. Pt presented to orthopedic surgeon for follow up because symptoms not resolved and was placed on Medrol Dosepak for possible issues related to remote hip replacement. When symptoms progressed, pt presented to hospital on 3/24. 3/24 lower extremity dopplers revealed thrombus in left leg that extended into saphenofemoral junction. Patient was then transferred to hospital for L iliac venous EKOS catheter placement for catheter-directed thrombolysis with alteplase on 3/25. Pt underwent second procedure on 3/26 where Angiojet thrombectomy and venoplasty of left external iliac, common femoral and femoral vein was performed.
50 2021-03-30 blood clot blood clots in arm/Blood Clots in Left Arm; swollen lymph nodes /Swollen Lymph Nodes in Left Arm; no... Read more
blood clots in arm/Blood Clots in Left Arm; swollen lymph nodes /Swollen Lymph Nodes in Left Arm; nodules were found on her lungs/Nodules in Lungs; arm swelling /Left Arm Swelling; Left Arm Redness; Left Arm Discomfort; Soreness at the Injection Site; This is a spontaneous report from a contactable consumer (Patient's Mother) calling on behalf of daughter. A 50-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, batch/lot number and expiration date unknown), via an unspecified route of administration, administered in Arm Left on 05Mar2021 13:30 at age of 50 years old at single dose for covid-19 immunisation. There was no medical history. There were no concomitant medications. The patient did not have prior vaccinations within 4 weeks. No adverse events following prior vaccinations. There were no additional vaccines administered on same date of the Pfizer suspect. The patient experienced the following after first dose. The patient experienced arm swelling /left arm swelling (hospitalization) on 09Mar2021 with outcome of recovering , blood clots in arm/blood clots in left arm (hospitalization) on 11Mar2021 with outcome of not recovered , swollen lymph nodes /swollen lymph nodes in left arm (hospitalization) on 11Mar2021 with outcome of not recovered , nodules were found on her lungs/nodules in lungs (hospitalization) on 11Mar2021 with outcome of unknown , soreness at the injection site on 05Mar2021 with outcome of not recovered , left arm discomfort on 08Mar2021 with outcome of not recovered , left arm redness on 09Mar2021 with outcome of not recovered. The patient was hospitalized from 11Mar2021 to 12Mar2021. On 05Mar2021 she began to have arm pain. 48 hours later, patient's arm started really hurting her, something about her arm being sore on the day of injection and reporter said she was going to be sore and when she got back from going away for the weekend, she thought uh oh, there was a problem here, this was not normal, not right. On 10Mar2021, she experienced swells arm swelling and went to urgent care which was diagnosed with swollen lymph nodes and given Cheplex prescription at urgent care. 11Mar2021, daughter was admitted to hospital by her provider. Daughter was found to have blood clots in arm and continued swollen lymph nodes. Daughter was given IV cheplex and Eliquis while in hospital. Daughter will have to be on Eliquis for next 3 months per reporter. The patient had her first vaccine, Pfizer, and became ill with blood clots, swollen lymph nodes, and wound up in the hospital. Reporter stated that she and the patient were worried about her getting the second shot. The patient was on blood thinners and was seeing a pulmonary doctor and hematologist. She didn't know about her getting the second shot and thought this should be reported. The patient was due for the second vaccine next week on 26Mar2021 and she was still sick, should it be postponed or what? The patient went the night before the hospitalization to the Urgent Care and the doctor prescribed Keflex, an antibiotic and saw her primary care doctor the next morning and she put her in the hospital. Reporter stated they were getting nervous and wanted to report for side effects. She stated the patient was home from the hospital but still sick really bad. The patient went to Urgent Care 10Mar2021, saw her primary care 11Mar2021 and was sent to the hospital 11Mar2021. Reporter later clarified that the patient was sent to the Emergency Room and after a few hours, she was sent upstairs to be admitted for a 24 hour hospital stay. The patient received Eliquis; Keflex as treatment. Fluids at the hospital, unknown type. Reporter stated they decided the patient wasn't doing really well and went to the Urgent Care that night and were given Keflex because they felt there was an infection. When they discovered it further that there were blood clots, the patient was told to stay on the antibiotic and given fluids and put on blood thinner, Eliquis, states patient had never been on a blood thinner before. Patient was admitted on 11Mar2021 for 24 hours. Reporter stated that they kept the medicine going and then felt she was stable enough to be discharged the next night at around 18:00 to continue with Keflex antibiotic and Eliquis for 3 months. Reporter stated they were told to contact a hematologist and pulmonary doctor for the nodules in her lungs and to contact her primary doctor if not doing better in one week, but they will probably contact her tomorrow. Reporter clarified that the patient had a chest x-ray a couple of months ago and everything appeared fine, so she thinks that the nodules developed after the vaccine. The patient had a chest x-ray on 11Mar2021 and nodules were found on her lungs, scheduled to follow up with lung doctor. Reporter stated whether they were there before or not was unknown. No follow up X ray yet. Reporter would like to know if daughter should get second dose? Second dose was scheduled 26Mar2021. Adverse events required visit to emergency room: Urgent Care the night before, follow up the next morning with primary doctor, the doctor got her in right away and said she needs to go to the hospital. Yes, patient went through the ER, doctor said that she would be coming and then after there a while, she was admitted to the hospital. Adverse events required visit to physician office. Patient saw the doctor on 11Mar2021 and was sent to the hospital. Information about lot/batch has been requested.
50 2021-04-02 palpitations had a little heart palpitation; achy; like a muted flu; runny nose; nose felt like it was burning on... Read more
had a little heart palpitation; achy; like a muted flu; runny nose; nose felt like it was burning on the inside; Sneezing; chills; feeling feverish; Elbow or right arm muscle was contracting or moving on its own; Heart fluttering; always cold; This is a spontaneous report from a contactable consumer (patient) via the medical information team and a Pfizer-sponsored program, COVAX US Support. This consumer reported similar events for two patients. This is the first of two reports. A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in the left arm on 10Mar2021 11:30 (lot number: EN6204, expiration date: Jun2021) as 0.3 mL, single dose for COVID-19 immunisation. Medical history included lupus from 2012 and ongoing; blood clot disorder from 2017 and ongoing, heart attack from 2010 and ongoing: heart attack/heart condition; stroke in 1992 and ongoing; Sjogren's syndrome from 2012 and ongoing; ongoing allergies to all sulfas, penicillins, latex (no manufacturer lot or expiration date); allergic to dye they put in CAT scans; obese from 2014; gastric bypass from 2014 and pulmonary embolism: rare and grew in her lungs in 2017 and was on apixaban (ELIQUIS) for that now. Concomitant medications included apixaban for pulmonary embolism and blood clotting disorder. The patient had no prior vaccinations within 4 weeks. The patient received a rubella shot and came down with German measles. Family medical history included a large family history of thoracic aortic dissections associated with vascular Ehlers-Danlos syndrome (EDS). The patient experienced heart fluttering on 10Mar2021 at 11:30; elbow or right arm muscle was contracting or moving on its own on 11Mar2021 at 15:00; chills and feeling feverish on 12Mar2021 at 22:30; nose felt like it was burning on the inside and sneezing, on 16Mar2021 at 10:00; achy in 19Mar2021; runny nose, like a muted flu, always cold and had a little heart palpitation in Mar2021. The patient received her first dose on 10Mar2021 and 2 days after she started having chills and feeling feverish. The patient had fever twice. A day before (18Mar2021) she had a slight fever, runny nose and chills. On 19Mar2021, she had chills, achy and felt like she has a fever, but she doesn't have a fever. It was like a muted flu; it was not horrible but can be debilitating at times because she can't function and was always cold. She constantly has chills, then her nose feels like it is burning on inside and she sneezed a few times. She added that 3 days before getting the vaccine (07Mar2021) she was not feeling well and had a rapid COVID test done and it was negative. The day of the actual day of vaccine the patient was okay. The patient has lupus and a blood clotting disorder for which she takes apixaban. She continued that she has not been out of the house since Mar2020. When she got the shot she had a little heart palpitation. She does not know why she was feeling this way after all these days. She wanted to know how long this would last and should she get tested for COVID. There was a lady that was sick when she got vaccinated and they allowed her in. The heart fluttering felt like it was in esophagus at first. It felt like it was going down her throat. It lasted only a couple of hours. She heard that from other people (her sister). No ER or physician's office required. The patient wanted to know how long the side effects were going to continue. The patient wanted to postpone her second dose until after Easter and her birthday, she did not want to be sick during that time. She has re-scheduled her second dose for 05Apr2021. Her son was getting married 27Jun2021 and she saw a study that immunity was still high at 62 days. The patient wanted to know if she would still have immunity or high antibodies on 27Jun2021 or would it still be effective. The outcome of achy, runny nose, like a muted flu, always cold and had a little heart palpitation was unknown. The patient has not recovered from chills and feeling feverish. The patient was recovering from the remaining events.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021312325 Same reporter, same drug and similar event, different patient.
50 2021-04-05 fibrin d dimer increased, haemoglobin decreased, loss of consciousness, platelet count decreased Paranoia - yelling at people talking to her on shoulder - gave night meds early - helped Unsteady w... Read more
Paranoia - yelling at people talking to her on shoulder - gave night meds early - helped Unsteady walking - had sit down then to bed Passed out twice - blood pressure down to 70/40 when paramedics took to hospital - IV fluids
50 2021-04-06 hypertension after 3-4 hrs bit my tongue, blood pressure escalate extremely high
50 2021-04-07 nosebleed She experienced Bell's Palsy; dizzy; bleeding out of my nose; earache; eyes are kinda blurry; My fac... Read more
She experienced Bell's Palsy; dizzy; bleeding out of my nose; earache; eyes are kinda blurry; My face went numb; This is a spontaneous report received from a Pfizer Sponsored Program. A contactable consumer, the patient reported for herself that a 50-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 08Mar2021 (at the age of 50-years-old) as single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included prednisone (MANUFACTURER UNKNOWN); valaciclovir hydrochloride (VALTREX) (MANUFACTURER UNKNOWN). On an unknown date, the patient experienced bell's palsy but upon contacting her physician she was prescribed an immunosuppressant which is Prednisone. She was asking if she can take the second dose. Patient stated, after about a week of first dose on an unspecified date in Mar2021, she got dizzy and started bleeding out of nose. On an unpecified date in Mar2021, 2 weeks in, she thought she had an earache. It started on Sunday, Monday and Tuesday. On an unspecified date in Mar2021 (Wednesday), the first thing she noticed while driving was eyes were kinda blurry and her face went numb and she couldn't close eye. Within 2 hours of numbness she saw the doctor who put her on Valtrex and later her doctor put her on prednisone. She has the 2nd dose scheduled for Monday 05Apr2021 and she is worried about taking it. The clinical outcomes of the she experienced bell's palsy, dizzy, bleeding out of my nose, earache, eyes are kinda blurry, my face went numb were unknown. Information about lot number has been requested.
50 2021-04-07 fainting Syncope; Vomiting; uncontrollable water diarrhea for almost 12 hours.; Severe stomachache; intestina... Read more
Syncope; Vomiting; uncontrollable water diarrhea for almost 12 hours.; Severe stomachache; intestinal cramping; Low grade fever; Chills; Sweats; This is a spontaneous report from a non-contactable consumer (patient). A 50-years-old female, non-pregnant, patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine at pharmacy or drug store via an unspecified route of administration, administered in left arm on 19Mar2021, at 50 years of age, (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history included fibromyalgia from an unknown date. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included nifedipine, clonazepam, estradiol and propranolol, all taken for an unspecified indication, start and stop date were not reported. In Mar2021 the patient experienced syncope, assessed as medically significant, vomiting, uncontrollable water diarrhea for almost 12 hours, severe stomachache, intestinal cramping, low grade fever, chills and sweats. No treatment was received for the events. All the events were resolving at the time of the report. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
50 2021-04-12 cerebrovascular accident, blood clot Blood clot, stroke, severe headaches, dizziness, vomiting
50 2021-04-12 cardiac arrest pt recieved vaccine at 1135 on 4/9, pt reported tongue swelling around 1130 the next day (4/10, 24 ... Read more
pt recieved vaccine at 1135 on 4/9, pt reported tongue swelling around 1130 the next day (4/10, 24 hrs after), presented to ED via EMS 1518, was diagnosed with angioedema likley due to ramipril, was intubated by 1624. pt had difficult intubation, was transferred to ICU, in critical condition on a ventilator, days later, after multiple cardiac arrests and multiple rounds of ACLS were performed, the pt was pronounced dead at 0127 on 4/12
50 2021-04-13 pulmonary embolism Pulmonary Embolism (blood clot)
50 2021-04-14 loss of consciousness blackout or passed out, dizziness, unable to walk, bitter taste in the mouth, dry heaving, rash, sho... Read more
blackout or passed out, dizziness, unable to walk, bitter taste in the mouth, dry heaving, rash, shortness of breath, extreme blood pressure immediately upon injection for 1 hour. Continued reactions 48 hours, extreme fatigue, blood pressure, dizziness, metal and bitter taste in the mouth, migraine, stomach upset, red polka dots on hands, itchiness underarms, cough, sore throat, and fever
50 2021-04-18 deep vein blood clot, chest pain, pulmonary embolism DVT in right leg; chest pain; PE in right lung was found on CT scan; numbness in both legs; Back pai... Read more
DVT in right leg; chest pain; PE in right lung was found on CT scan; numbness in both legs; Back pain; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via an unspecified route of administration, administered in arm left on 18Mar2021 13:30 (Lot Number: EP7534) as single dose for covid-19 immunisation. Medical history included breast cancer, hypothyroidism, diabetes. The patient did not have covid prior vaccination and no covid tested post vaccination. No known allergies. The patient was not pregnant. Concomitant medications in two weeks included metformin; atorvastatin (LIPITOR); levothyroxine sodium (SYNTHROID), vit d, multivitamin. No other vaccine in four weeks. Back pain started on 20Mar2021, chest and back pain on 24Mar2021 and chest pain continued until she went to the ER on 27Mar2021. When PE in right lung was found on CT scan on 23Mar2021 12:00 PM. The patient was hospitalized on 27Mar2021 and heparin was started and continued until 29Mar2021 when she was released. The DVT in right leg was found on 28Mar2021 with ultrasound after she mentioned numbness in both legs on 23Mar2021 12:00 PM. She started apixaban (ELIQUIS) on 29Mar2021 before leaving the hospital and still taking it now. She went to follow up appointment with hematologist that suggested that she remained on apixaban and return in 10 weeks for another checkup. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event). Number of days hospitalisation was 3. Treatment received for events included heparin and apixaban. The outcome of events was recovering. The patient received second dose of BNT162B2 in arm left on 09Apr2021 12:30 (Lot Number: EK8727).
50 2021-04-20 heart rate increased hot flashes; difficulty breathing; swelling of throat; fast heartbeat; dizziness; weakness; tinnitus... Read more
hot flashes; difficulty breathing; swelling of throat; fast heartbeat; dizziness; weakness; tinnitus; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received bnt162b2 (BNT162B2, COVID 19), dose 1 via an unspecified route of administration, administered in left arm on 31Mar2021 13:45 (Batch/Lot Number: EN6204) as single dose for covid-19 immunization. Patient was not received any other vaccine in four weeks, Vitamin B12 received in two weeks. Concomitant medication included cyanocobalamin (VITAMIN B12). Patient was not pregnant. The patient experienced difficulty breathing, swelling of throat, fast heartbeat, dizziness, weakness, tinnitus, hot flashes, could not focus on 31Mar2021 13:45. AE resulted in Doctor or other healthcare professional office/clinic visit, Life threatening illness (immediate risk of death from the event). The patient underwent lab tests and procedures which included allergies to shellfish (though allergy test says otherwise, wool, poison ivy, jewelry not identified why, heart rate fast on 31Mar2021. There was no covid prior vaccination, no covid tested post vaccination. Therapeutic measures were taken as a result of hot flashes, difficulty breathing, swelling of throat, fast heartbeat, dizziness, weakness, tinnitus. The events outcome were resolved with sequel. Pfizer is a marketing authorization holder of BNT162B2 in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of BNT162B2 has submitted the same report to the regulatory authorities. No follow-up attempts are needed. No further information is expected.
50 2021-04-21 heart rate increased, chest discomfort *4/4 Morning felt like I couldn't walk, knew my feet were their, but couldn't register to move for h... Read more
*4/4 Morning felt like I couldn't walk, knew my feet were their, but couldn't register to move for hr and then got up, EXTREME pain in center of my left armpit (to point of almost crying and it was worse than my kidney stone pain I had for a week) and all over pain in body-hard to even move much this day...I slept in 12 hr increments till next day. Noticed my Heart rate was very high constantly between 100-115 ( on my wrist monitor) * On 4/5 Woke up and told myself to get moving for day, arm was turning very red at this point and swelling bad along with armpit along edge and was hot and still painful. Was up for 7 hr.. I got in shower that evening and felt weird midway and my head felt like a whoosh and thought I was going to pass out (normal temp in shower) held onto shower got out was fine for about 20 min and then I started extreme shaking uncontrollably and teeth were chattering from chills. Went to get a Tylenol because I knew something was not right and within 30 min started sweating profusely with fever (I didn't even get up because I felt so crappy) *4/6 Woke up, felt a little better, arm, armpit and side of armpit red, hot and swollen still. Was up for 9 hrs, but when I went to bed and laid down, I felt like I couldn't breathe well...something told me to take a deep breath and I felt something like a pop in chest and then I felt like I was breathing better. Was not still feeling good on 4/7 but went back to work, on 4/8 felt a lot better, then woke 4/9 with Migraine and felt terrible and my heart felt weird...I called the Health Department and asked what to do and they recommended going to doctor... but a Nurse followed up with me which was very nice. Went to doctor and my Blood Pressure was 179/98 at that time. They ran blood work and prescribed me a antibiotic for my arm and armpit area. I want to add as well, not sure if this matters, but my shot was not in center of arm...it was closer to inner part of upper shoulder closer to chest.
50 2021-04-22 deep vein blood clot Right leg popliteal DVT. Symptoms began approximately 3/28/21 (14 days after receiving vaccine), a... Read more
Right leg popliteal DVT. Symptoms began approximately 3/28/21 (14 days after receiving vaccine), and patient presented to clinic for diagnosis 4/14/21.
50 2021-04-24 fainting Dizziness/ extreme dizziness/ Some degree of dizziness every day/ Varies from daily light headedness... Read more
Dizziness/ extreme dizziness/ Some degree of dizziness every day/ Varies from daily light headedness to extreme dizziness; had extreme fatigue; Almost fainted once; This is a spontaneous report from a contactable consumer (patient). A 50-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6199), via an unspecified route of administration, administered in right arm on 03Mar2021 19:30 at single dose for COVID-19 immunisation. The patient's medical history included Hashimoto's autoimmune, and known allergies to penicillin. The patient's concomitant medications included liothyronine, and levothyroxine, both taken for an unspecified indication, start and stop date were not reported. The patient had no other vaccine in four weeks. The patient had no COVID prior to vaccination and was tested for COVID post vaccination. The facility type vaccine was Pharmacy or Drug Store. The patient experienced dizziness on 10Mar2021 at 12:00 and has not ceased. It varies from daily light headedness to extreme dizziness. The patient almost fainted once on an unspecified date in Mar2021. The patient had some degree of dizziness every day. The patient also had extreme fatigue since 09Mar2021. The patient was completely normal and physically active before the first dose, and she have not felt normal since. Events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included nasal swab, with both negative test results on 17Mar2021 and on 31Mar2021. No treatment was received for the events. The outcome of the events were not recovered.
50 2021-04-24 lightheadedness hearing is also coming and going periodically in both ears; I also felt like I was going to pass out... Read more
hearing is also coming and going periodically in both ears; I also felt like I was going to pass out about 5 minutes after the shot; Tinnitus in both ears started within about a half hour; I also have some facial numbness/tightness; I also have some facial numbness/tightness; intermittent ear pain; My joints in my feet and the bottom of my feet hurt.; ear fullness; very sensitive to sound; This is a spontaneous report from a contactable consumer. A 50-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in right arm on 23Mar2021 at 10:15 (Batch/Lot Number: ER8727) as single dose for COVID-19 immunisation. Medical history included Lyme disease from an unknown date. The patient has no known allergies. The patient is not pregnant. Concomitant medications included colecalciferol (VITAMIN D); probiotics; fish oil all taken for an unspecified indication, start and stop date were not reported. On 23Mar2021 at 10:30 AM, the patient reported of tinnitus in both ears started within about a half hour of receiving first dose. The patient also felt like she was going to pass out about 5 minutes after the shot. The patient also has some facial numbness/tightness that started the same day as her shot (after the shot). The tinnitus, intermittent ear pain, ear fullness was reported as still continuing. The patient reported that her hearing is also coming and going periodically in both ears. The patient was also very sensitive to sound now. The patient's joints in her feet and the bottom of her feet hurt. Therapeutic measures were taken as a result of the events. Treatment of antihistamine and nasal spray was recommended. The patient do not have covid prior to vaccination and was not tested for covid post vaccination. The patient has not recovered from the events.
50 2021-04-24 chest discomfort, heart rate increased rapid heart rate; heaviness in chest; light-headed; need to catch breath; This is a spontaneous repo... Read more
rapid heart rate; heaviness in chest; light-headed; need to catch breath; This is a spontaneous report from a contactable consumer (who is also the patient). A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EP6955), via an unspecified route of administration in the right arm, on 24Mar2021 15:45, as single dose, for COVID-19 immunisation. Medical history included DCIS stage 0 in left breast in 2017 and known allergies to sulfa based medications. The patient was not pregnant at the time of vaccination. The patient did not have COVID-19 prior to vaccination. There were no concomitant medications (no other medications in two weeks). The patient did not receive other vaccines in four weeks. On 26Mar2021, the patient began to experience rapid heart rate and heaviness in her chest. She went to the hospital and was admitted for 1 day on an unspecified date. It was reported that after so many tests (unspecified) in Mar2021, they found nothing. The patient felt light-headed and felt like she needed to catch her breath. Her heartbeat was prominent at times. At the time of the report, the patient was wearing a heart holster for 48 hours. The events resulted to emergency room and physician's office visits. Treatment for the events was reported as unknown. The patient had COVID-19 Nasal Swab in 31Mar2021 and was negative. The outcome of light-headed and need to catch breath was not resolved; and the outcome of rapid heart rate and heaviness in chest was unknown.
50 2021-04-25 pulmonary embolism, chest pain, fainting, cardiac arrest On April 23,2021 patient was at her home and started complaining of shortness of breath and chest pa... Read more
On April 23,2021 patient was at her home and started complaining of shortness of breath and chest pain. She called 911 and they responded to her residence at 0500 a.m. While being assessed, patient collapsed. She was asystolic. CPR was started but to no avail. She was transported to the coroner's office where an autopsy was performed. She had bilateral pulmonary thromboemboli. There were not deep vein thromboses found in her legs.
50 2021-04-26 fainting fainted; slammed my face on the bathroom floor and broke my nose (among other cuts & bruises); nause... Read more
fainted; slammed my face on the bathroom floor and broke my nose (among other cuts & bruises); nausea/mild queasiness; dizziness; heat; slammed my face on the bathroom floor and broke my nose (among other cuts & bruises); slammed my face on the bathroom floor and broke my nose (among other cuts & bruises); slight fever/mild queasiness; slammed my face on the bathroom floor; This is a spontaneous report from a contactable consumer, the patient. This 50 year-old patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: ER8733), dose 1 , single dose via an unspecified route of administration in the left arm on 31Mar2021 at 02:30 PM (at the age of 50 years-old) for COVID-19 vaccination. Medical history included Grave's disease under control with medication. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included desogestrel, ethinylestradiol (KARIVA), methimazole, lansoprazole and atorvastatin. The patient had no known allergies. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 01Apr2021 at 12: 30 AM, 10 hours after vaccination administration, the patient experienced a sudden wave of severe nausea, dizziness, and heat and fainted. She slammed her face on the bathroom floor and broke her nose (among other cuts & bruises). Afterwards, her only symptoms were fainting injuries, slight fever/mild queasiness for 2 days. The events required a doctor or other healthcare professional office/clinic visit. Laboratory tests included a nose X-ray. Treatment was received for nausea, dizziness, heat and fainted, fever, slammed face, broke her nose (among other cuts & bruises). The clinical outcome of nausea, dizziness, heat and fainted, fever, slammed face, broke her nose (among other cuts & bruises) was unknown. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
50 2021-04-27 blood clot 15cm Blood clot in left leg - lower calf.; Superficial vein prominence; This is a spontaneous report... Read more
15cm Blood clot in left leg - lower calf.; Superficial vein prominence; This is a spontaneous report from a contactable consumer (patient herself). This 50-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number ER8732), via an unknown route in the left arm, on 27Mar2021 at 14:45 (at the age of 50-year-old) at single dose for COVID-19 immunisation, administered at hospital. Relevant medical history included Factor V Leiden and varicose veins. The patient did not have allergies. The patient did not have COVID-19 before vaccination. Relevant concomitant medications included acetylsalicylic acid (ASPIRIN), levothyroxine sodium and Women's multivitamin (unspecified). On 07Apr2021, the patient presented 15 cm blood clot in the left leg-lower calf and superficial vein prominence. The events required a physician office visit. An ultrasound was done but results were not provided. Therapeutic measures taken as result of the events included enoxaparin sodium (LOVENOX) injections for 14 days. Post-vaccination COVID test was not performed. The patient was recovering from the events.
51 2020-12-31 chest pain *12/21-22-increased soreness at site of injection...resolved Onset on 12/28 of Swollen lymph nodes, ... Read more
*12/21-22-increased soreness at site of injection...resolved Onset on 12/28 of Swollen lymph nodes, with pain, on Right side of body with increased sensitivity at Left Axillary/side of breast area. Onset on 12/30 Fever, Severe Body aches/joint pain, dry cough, chest pain with min SOB, Headache. *Exposure to 4 people on Sat 12/26 who have tested positive for Covid on 1/1/20 but their symptoms began 12/28 through 01/30.
51 2021-01-03 oxygen saturation decreased 20 minutes after receiving the vaccination the resident started to not feel well. She said she felt ... Read more
20 minutes after receiving the vaccination the resident started to not feel well. She said she felt very far away and just kept repeating I don't feel well. She was diaphoretic and her chest was very red and she kept scratching and rubbing it at it. I asked if she wanted IM Benadryl or epipen and she at first denied. She also said she felt like she needed to focus on her breathing. At this time we decided it was best to administer Epipen x 1 dose. Immediately after she felt better. She was observed for another 30 minutes and then went home. at 7:17pm I called and spoke with her. She said her arm was sore and that her oxygen levels were about 88-89% which is low for her but she said she felt fine and is currently working right now.
51 2021-01-04 heart rate increased chest flushing; Racing heart rate; This is a spontaneous report from a contactable nurse (patient). ... Read more
chest flushing; Racing heart rate; This is a spontaneous report from a contactable nurse (patient). A 51-year-old non-pregnant female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration in the left arm on 24Dec2020 11:30 at a single dose for COVID-19 immunization. The patient has no medical history. Concomitant medication included ascorbic acid, betacarotene, calcium carbonate, calcium pantothenate, calcium phosphate dibasic, colecalciferol, copper sulfate, cyanocobalamin, ferrous fumarate, folic acid, lysine hydrochloride, magnesium oxide heavy, manganese sulfate monohydrate, nicotinamide, potassium iodide, potassium sulfate, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride, tocopheryl acid succinate, zinc oxide (ONE A DAY MULTI VITAMIN & MINERALS). The patient did not receive other vaccine in four weeks. The patient previously took ephedrine and experienced allergies. The patient was not diagnosed with COVID-19 prior vaccination and was not tested for COVID-19 post vaccination. The patient experienced chest flushing and racing heart rate on 24Dec2020 11:45. Outcome of the events was recovered in Dec2020; no treatment was needed for the events. The events was assessed as non-serious.
51 2021-01-04 heart rate increased lightheaded; chills; tingling/buzzing/numbness/swelling in face and lips; tingling/buzzing/numbness/... Read more
lightheaded; chills; tingling/buzzing/numbness/swelling in face and lips; tingling/buzzing/numbness/swelling in face and lips; tingling/buzzing/numbness/swelling in face and lips; tingling/buzzing/numbness/swelling in face and lips; swelling in face; swelling in face and lips; rapid heart rate; flushed neck, upper chest, and face-a red rash here; This is a spontaneous report from a contactable consumer (patient). This 51-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at left arm on 28Dec2020 03:30 PM at single dose (lot number: EH9899) for COVID-19 immunization. Medical history included asthma and known allergies to medications, food, or other products. Concomitant medications include Estradiol received in two weeks. No other vaccine in four weeks. The patient was not pregnant. The patient experienced lightheaded; chills; tingling/buzzing/numbness/swelling in face and lips; rapid heart rate; flushed neck, upper chest, and face-a red rash here that resembled sunburn, but was not painful; on 28Dec2020 04:00 PM. The patient took antihistamine (Claritin) and rest as treatment. All events were reported as non-serious. The patient had no Covid prior vaccination, no Covid tested post vaccination. Outcome of all events was recovering.
51 2021-01-05 lightheadedness 15 minutes after the immunization I felt a little lightheaded. It was mild so I tried to leave, but ... Read more
15 minutes after the immunization I felt a little lightheaded. It was mild so I tried to leave, but then felt presyncopal. Sat down, drank water and ate a cookie. The feeling did not subside. After about another 20 minutes, felt tingly all over. After about 5 minutes of that, the tip of my tongue started too tingle. I alerted the staff and they checked my pulse (nl in the low 60s) and my BP (normal SBP 112). They gave me liquid Benadryl 25 mg and the tingling immediately stopped but I still felt lightheaded. They transported me to the ED. I was given 1 L of fluid and monitored and rested for about an hour, then I felt fine. No other tests or meds given
51 2021-01-05 palpitations Palpatations and systemic burning sensation. Lasted approx. 2 minutes then goes away; 2 episodes wit... Read more
Palpatations and systemic burning sensation. Lasted approx. 2 minutes then goes away; 2 episodes within 5 minutes of each other.
51 2021-01-05 palpitations Palpitations reported by patient. 35 minutes monitored Vital Signs within normal limits Symptoms re... Read more
Palpitations reported by patient. 35 minutes monitored Vital Signs within normal limits Symptoms resolved. Released to home.
51 2021-01-06 palpitations AT 7:45 AM ON SATURDAY, 01/02/2021, I STARTED HAVING DIZZINESS, LIGHT-HEADEDNESS, AND PALPITATIONS. ... Read more
AT 7:45 AM ON SATURDAY, 01/02/2021, I STARTED HAVING DIZZINESS, LIGHT-HEADEDNESS, AND PALPITATIONS. THE MORNING OF 01/05/2021, I DEVELOPED CHILLS WITHOUT FEVER. WENT TO MY FAMILY PRACTICE, LIFETIME MEDICINE, AND WAS SEEN BY NIDA ARIF, PA FOR ABOVE PERSISTING SYMPTOMS. AN EKG WAS DONE IN THE OFFICE RESULTING IN NORMAL SINUS RHYTHM. AS OF 01/06/2021, CHILLS, DIZZINESS AND LIGHT-HEADEDNESS RESOLVED. PALPITATIONS CONTINUE TO PERSIST AS OF 01/07/2021 WHEN THIS REPORT WAS FILLED OUT AND SUBMITTED.
51 2021-01-07 fast heart rate Facial swelling, shortness of breath, nasal stuffiness, tachycardia >150, IV solumedrol, Benadryl an... Read more
Facial swelling, shortness of breath, nasal stuffiness, tachycardia >150, IV solumedrol, Benadryl and Pepcid Relief in symptoms upon discharge at 2330
51 2021-01-07 palpitations, chest pain I started few hours later started feeling thought it was stress. The next morning around 9am high mo... Read more
I started few hours later started feeling thought it was stress. The next morning around 9am high moderate pain left leg jaw, chest hurt, sudden panic attack and I had to calm down for minutes. I informed my coworker I was having a reaction and then it stopped. Then I scheduled an appt with my PCP had lab work, EKG results was normal. On 12/24 still exp high mild left jaw pain, heart racing and chest pain .I was scheduled stress test on 12/30 was normal.
51 2021-01-07 palpitations Today at about 10:20 am began feeling lightheaded, dizzy, with palpitations, HR 100-120s. Also, hea... Read more
Today at about 10:20 am began feeling lightheaded, dizzy, with palpitations, HR 100-120s. Also, headache, mild muscle aches, chills. After about 2 hours, did not improve therefore was directed to the ED. EKG was normal. CBC, CMP, TFTs all normal. Was monitored for a couple hours and HR improved. At home it took until 17:40 for HR to consistently be 100 or less.. still feel fatigued, headache, and achy.
51 2021-01-08 palpitations After 20 minutes my heart started to race and pound in my chest, I was flushed and had a dry mouth. ... Read more
After 20 minutes my heart started to race and pound in my chest, I was flushed and had a dry mouth. I sat and monitored what was happening and then notified the staff that it was not improving. I was directed to go to the ER for further evaluation and went. They monitored me and it resolved after about 3 hours and went home. No other issues occurred.
51 2021-01-08 hypotension, lightheadedness, heart rate increased Hypotension 90/60 experienced; Dizziness; almost passed out; rapid heart beat and unable to breath
51 2021-01-08 fast heart rate Patient developed tachycardia, vomited and trouble breathing
51 2021-01-08 lightheadedness c/o dizziness, near-syncope 10 minutes post-vaccination
51 2021-01-09 chest discomfort 1/7/2021 at 1230 I began experiencing SOB, assumed it was asthma, 2 puffs of albuterol taken. At 13... Read more
1/7/2021 at 1230 I began experiencing SOB, assumed it was asthma, 2 puffs of albuterol taken. At 1330 still SOB with chest pressure/tightness, no change, no cough, no feeling appropriate, 2 puffs albuterol. At 1415 reported to the vaccination clinic and told them of symptoms, SOB with movement, and general pressure in the chest. 2 Tylenol taken. I was required to check into the ER for Observation. oxygen saturation checked for 2 hours. no change in symptoms, no worsening. I then left work in the ER and went home. At approx. 1800 ate dinner, no real taste, but needed to eat. At 1830 showered, 2000 to bed, just feeling malaise. continued pressure in the chest and general soreness. 2 Tylenol Through the night I slept very poorly, tossed and turned, woke frequently. Body and joints with extreme pain everywhere it touched the mattress. I have a screw in my left foot, it felt like it was on fire at some point during the night. My left leg ached up into my hip. On the morning of January 8, woke approx 0800 with a temperature of 99.9, pain in all my joints, back and up into neck, headache, and nausea. Took 2 Tylenol, 3 ibuprofen, and 4 mg Zofran. 1200 symptoms began to lessen and felt like I had the flu, still sore, but less severe. 1300 - 2 Tylenol Slept better, just sore January 8 night. January 9 - 2 Tylenol in the morning, sore everywhere, right arm site sore, headache, eye pain, intermittent nausea. 2 more tylenol around 1800 January 10, 2 tylenol 0900, remain sore but lessening, headache and eye pain continues, intermittent nausea
51 2021-01-09 chest discomfort, hypertension Allergic reaction 10 minutes after injection. High BP 171/110, chest tightness, eye swelling, left b... Read more
Allergic reaction 10 minutes after injection. High BP 171/110, chest tightness, eye swelling, left back of shoulder, neck, face pain , moderate severe headache. SOB.
51 2021-01-09 fast heart rate, blood pressure increased, hypertension, chest discomfort Tachycardia almost immediately after injection 100-110s. Slight tightness of chest, but I was tryin... Read more
Tachycardia almost immediately after injection 100-110s. Slight tightness of chest, but I was trying not to panic. Tachycardia increased to 130s for 2 minutes then came down to 100s, BP 140/86, a little nausea and slight headache. Better at 4:45 thought I was good to leave. Then BP spiked to 180/110s, HR 136, transported to ER for monitoring. Tachycardia and HTN would continue to cycling elevate over next 2hours before being discharged with HR of 100s and BP 150/86
51 2021-01-10 heart rate increased 0900 - Vaccine given 0910 - felling warm all over, fast HR, itchy arm at injection site (x5min) 0920... Read more
0900 - Vaccine given 0910 - felling warm all over, fast HR, itchy arm at injection site (x5min) 0920 - symptoms improving
51 2021-01-10 chest discomfort Dizzy, Headache, unsteady on feet, chest feels heavy, nauseated
51 2021-01-10 chest pain Shortness of breath Arm pain Lump under left arm pit Pain goes across chest and down arm No fever Ac... Read more
Shortness of breath Arm pain Lump under left arm pit Pain goes across chest and down arm No fever Achy all over Left arm down to fingers and up the arm and across the chest to swollen arm under arm pit is in pain
51 2021-01-11 chest pain Puffiness at wrist of same arm of injection, 2 and 1/2" L x 1 and 1/2" W. Also reporting shooting pa... Read more
Puffiness at wrist of same arm of injection, 2 and 1/2" L x 1 and 1/2" W. Also reporting shooting pain alternating down left arm, right leg, and across chest and head
51 2021-01-11 fast heart rate anaphylaxis; throat tightening; throat tightening/tingling; throat tightening/tingling/soreness; dry... Read more
anaphylaxis; throat tightening; throat tightening/tingling; throat tightening/tingling/soreness; dry wheezy cough a little dizziness; dizziness; tachycardia; Itching; chills; numb R foot; Low grade temp; h/a today; This is a spontaneous report from a contactable Nurse (patient). A 51-years-old female patient (no pregnant) started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number el3248), via an unspecified route of administration on 06Jan2021 11:00 at the first single dose at left arm for covid-19 immunisation. Medical history included supraventricular tachycardia, adrenal insufficiency, hypothyroidism, attention deficit hyperactivity disorder, hypermobility syndrome, developmental hip. Concomitant medication included hydrocortisone, trazodone, levothyroxine sodium (LEVOTHROID), bupropion hydrochloride (WELLBUTRIN). The patient previously took erythromycin, morphine and experienced drug hypersensitivity. The patient experienced anaphylaxis, throat tightening/tingling/soreness, dry wheezy cough a little dizziness and tachycardia. Itching, numb R foot, Low grade temp and chills and headache on 06Jan2021 11:15. Seriousness criteria reported as life threatening. Taken to ER had IV benadryl, solumedrol, pepcid for anaphylaxis. Placed on O2 and given albuterol nebulizer. Had IV fluid bolus. Now on benadryl and 5 days of prednisone. The patient felt completely fine prior to vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 06Jan2021. The outcome of events was recovering. No other vaccine in four weeks; No covid prior vaccination.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of anaphylaxis presented as throat tightening/tingling/soreness, dry wheezy cough a little dizziness and tachycardia. Itching, numb R foot, Low grade temp and chills and headache cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product. The underlying predisposing condition of drug allergies may put the patient at high risk of anaphylactic reactions. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
51 2021-01-11 cerebrovascular accident on 1/8/2021 17:30 patient taken to ER, cerebellar hemorrhage, stroke, aneurysm
51 2021-01-12 chest discomfort Flushing of face and rash all over chest. Swelling to eyes, nausea, stabbing pain and heaviness to ... Read more
Flushing of face and rash all over chest. Swelling to eyes, nausea, stabbing pain and heaviness to left neck and under arm, chest pressure, vomiting, and loose stools
51 2021-01-13 chest pain received my shot at 8:15 am, within approximately 45min I felt a very slight heaviness to my breath... Read more
received my shot at 8:15 am, within approximately 45min I felt a very slight heaviness to my breathing something similar to allergy season belreathing, and a slight headache on my rr temple. This was nothing that stopped me or slowed me down that day. At approx 10:30pm I awoke from a deep sleep with SHARP chest pains, at 11pm chills, 1am fever and discomfort, 2am muscle aches. I slept on my left side to keep blood circulating to my heart which seemed to ease some of my discomfort. My first night was rough. I awoke Thurs (12/24) with a swollen left foot and leg. some rt leg pain, joint pain in my left knee. I pushed myself to get up and move and go about my day. Friday, I still had a little left foot foot swelling and pain, knee pain, but kept pushing. The handout says if symptoms persist for longer than 24-48 to seek medical care, I have not. Friday, (12/25/20)was Christmas and much of the day was non eventful. At approx 530pm. I felt a bulging not in the center of my chest which was tender to the touch. This concerned me. I gently messaged the area, rested a bit but continued to move up and down the stairs. That discomfort and the bulge decreased within a few hours. Saturday, (12/26) 4:am and I have notice much of the swelling in my foot and legs has decreased, however, I now have bruising. The sore arm is gone, and I am hopefully, all is well. I forgot to mention, I have had intermittent persistent cough with slight sob, something similar to the start of allergy season, but it is brief. I have been coughing at night. I have a history of whooping cough. And gastric bypass.
51 2021-01-14 chest discomfort, chest pain, palpitations Fever, sensation of heart pounding in my chest, dizziness and weakness, fatigue, severe joint pain, ... Read more
Fever, sensation of heart pounding in my chest, dizziness and weakness, fatigue, severe joint pain, body aches, skin sensitivity, headache, chest tightness and burning on inspiration, runny nose, unproductive cough, just felt horrible with all of this for two days fever ran between 99.7 and 100.6. Symptoms began to resolve and no fever by day three. Every day after continued to improve but joint pain, weakness with a general malaise through Thursday. It is now the following Friday and I am still experiencing fatigue and just a general feeling of not being quite 100%.
51 2021-01-14 hypertension Reactions: Injection site pain Injection site swelling Injection site redness Sever fatigue Swelling... Read more
Reactions: Injection site pain Injection site swelling Injection site redness Sever fatigue Swelling face/eyes Muscle pain - legs Muscle weakness - legs New onset hypertension Dizziness
51 2021-01-14 chest pain Received vaccine on 1/6, mild fever/achiness on 1/7. On 1/8 had some chest pain and SOB. This cont... Read more
Received vaccine on 1/6, mild fever/achiness on 1/7. On 1/8 had some chest pain and SOB. This continued to get worse on Friday. By Saturday, patient felt she could not get comfortable and was more short of breath. She went to the ER and after multiple tests they found multiple pulmonary emboli. Of note, patient took a long flight on 1/6 and is on hormone replacement therapy.
51 2021-01-14 chest discomfort Shortness of breath; Joint pain; fatigue; headache; ribs pain; chest pressure; burning feeling of my... Read more
Shortness of breath; Joint pain; fatigue; headache; ribs pain; chest pressure; burning feeling of my eyes; This is a spontaneous report from a contactable healthcare professional reporting for herself. A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 04Jan2021 03:45 PM (at the age of 51 years old) as a single dose in the left arm for COVID-19 vaccination. Relevant medical history included prior to the vaccination, the patient was diagnosed with COVID-19 on an unknown date. The patient did not have any known allergies to medications, food, or other products. Concomitant medication (other medications taken in two weeks) were none. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 05Jan2021, at 05:00 AM, the patient experienced shortness of breath, joint pain, headache, fatigue, ribs pain, chest pressure and burning feeling of her eyes. Treatment received for the events included an inhaler and acetaminophen (TYLENOL). The outcome of the events shortness of breath, joint pain, headache, fatigue, ribs pain, chest pressure and burning feeling of her eyes was recovering. Since the vaccination, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
51 2021-01-14 chest discomfort body itching, eye itching and irritation, body warm, chest tightness, bradycardia
51 2021-01-14 chest discomfort body itching, eye itching and irritation, body warmth, chest tightness, bradycardia
51 2021-01-16 palpitations First dose on 12/18/2020 Second dose on 1/04/2021 Intermittent heart palpitations began early am on... Read more
First dose on 12/18/2020 Second dose on 1/04/2021 Intermittent heart palpitations began early am on Monday, Jan 11th and occurred again on Tuesday, Jan 12th am (worked nightshift). Again appeared the evening of Wed, Jan 13th. On Thursday, Jan. 14, made appt with my primary MD and appt was at 3 pm the same day. EKG performed at office and was Normal sinus rhythm. BP and HR normal too. MD advised to monitor and call back as needed.
51 2021-01-17 heart rate increased Got my second dose of Pfizer, 12 hrs later developed fever (103 F), chills, myalgia, headache. Fati... Read more
Got my second dose of Pfizer, 12 hrs later developed fever (103 F), chills, myalgia, headache. Fatigue, bilateral orbital pain. No visual problems. Took Tylenol every 4 hrs and fever (101. 5)returns in 1-2 hrs. Pulse ox remained normal, 98%, but pulse was 99/min. Usually my resting pulse ox is 55/minutes. Was unable to go to work and see patients. Had these symptoms for 48 hrs even though stayed in bed, took Tylenol around the clock and drank plenty of fluids (2-3 liters of water in addition to natural orange and apple juices). Never lost appetite either, do eating my vegetables and fish diet. Ice cream help between Tylenol?s. Completely resolved after 72 hrs. Now still have LEFT injection site tender deltoid and left axillary tender nodes, improving as well. All along breathing fine, no cough or congestion or sore throat. No anosmia or dysgeusia. This was after my second Pfizer dose. After the First dose only had tenderness on the RIGHT deltoid muscle injection site and tender axillary node, resolved by now.
51 2021-01-17 palpitations Nausea, palpitations, Headache, Chills, severe achiness and fatigue, fever, pain at the injection s... Read more
Nausea, palpitations, Headache, Chills, severe achiness and fatigue, fever, pain at the injection site and whole injection site arm soreness.
51 2021-01-17 loss of consciousness On 1/8 I passed out at home, losing consciousness for a few seconds.
51 2021-01-18 heart rate increased 10 min after recieving vaccine: - increased HR - itchy over entire body - Benadryl given - ER for fu... Read more
10 min after recieving vaccine: - increased HR - itchy over entire body - Benadryl given - ER for further eveluas
51 2021-01-18 palpitations Fatigue, wheezing, soreness, palpitations
51 2021-01-18 fainting vasovagal syncope followed by panic attack
51 2021-01-19 palpitations, chest discomfort Abnout 5 minutes after getting her vaccine she began to feel short of breath, tightness, and palpita... Read more
Abnout 5 minutes after getting her vaccine she began to feel short of breath, tightness, and palpitation. In the ED, patient was given IM epi x 1, IV benadryl & solumedrol. Patient states that she felt better. Patient has had a similar allergic rxn in the past to shrimp, beta blockers and lisinopril (cough). Pt has never had to use epinephrine for her allergic reactions in the past. Patient has an epi-pen at home for her son (peanut allergy).
51 2021-01-20 chest discomfort Symptoms were first noted 12/24/2020. She had the Pfizer Covid vaccine at about 6pm. At about 10 pm ... Read more
Symptoms were first noted 12/24/2020. She had the Pfizer Covid vaccine at about 6pm. At about 10 pm she had mild chest tightness. It persisted for >24. hours. She also had injection site soreness. She was tired for a day. If she talked a lot or got angry, she found it a little difficult to breathe. (Her mother was in the hospital and she had been talking a lot.) She did not have any other symptoms. She reports she was not stressed when she had the vaccine: her mother?s stressful problem started in January. The patient?s symptom severity is rated as: ?mild,? ?not very severe.? If she did not talk, she did not feel anything. The SECOND DOSE was given at my office. The Covid vaccine was administered and the patient was observed for two hours. This was from Pfizer-Biontech Lot EL3246, expiring 4/2021. She had some chest tightness and was given an albuterol nebulizer treatment. Her symptoms resolved and she was discharged to home. I phoned her the next day. She had mild dyspnea the day after the vaccination that resolved that night. She did not have a fever, but did have local soreness, fatigue, body ache, and a headache, for which she took Tylenol. She did see her primary care physician and they discussed the patient?s anxiety due to her mother?s poor health. An EKG will be done.
51 2021-01-20 chest discomfort feeling malaise; general soreness/Body and joints with extreme pain everywhere it touched the mattre... Read more
feeling malaise; general soreness/Body and joints with extreme pain everywhere it touched the mattress; no real taste; chest pressure/tightness/ general pressure in the chest; SOB/ SOB with movement; Body and joints with extreme pain everywhere it touched the mattress; a screw in left foot, it felt like it was on fire at some point during the night; My left leg ached up into my hip; fever 99.9; HA; eye pain; intermittent nausea; This is a spontaneous report from a contactable nurse (patient). This 51-year-old female patient (non-pregnant) received the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0142) on 07Jan2021 at 11:15, in right arm, for COVID-19 immunisation. Medical history included asthma, allergies to latex, banana, kiwi and acetylsalicylic acid (ASPIRIN). The patient received the first dose of BNT162B2 vaccine on 17Dec2020 at 19:45, lot number EJ1685, in right arm. The patient had no COVID prior vaccination. No other vaccine was given in 4 weeks. COVID was not tested post vaccination. Concomitant medications included thyroid (ARMOUR THYROID) and escitalopram. On 07Jan2021 at 12:30 the patient began experiencing SOB; assumed it was asthma, 2 puffs of albuterol were taken. At 13:30 she had still SOB with chest pressure/tightness, no change, no cough, no feeling appropriate, 2 puffs albuterol. At 14:15 reported to the vaccination clinic and told them of symptoms, SOB with movement and general pressure in the chest. 2 paracetamol (TYLENOL) were taken. She had to check into the ER for observation. Oxygen saturation was checked for 2 hours. No change in symptoms, no worsening. She then left work in the ER and went home. At approximately 18:00 she ate dinner, no real taste, but needed to eat. At 18:30 she showered, at 20:00 she went to bed just feeling malaise, continued pressure in the chest and general soreness. 2 Tylenol. Body and joints with extreme pain everywhere it touched the mattress. She had a screw in her left foot, it felt like it was on fire at some point during the night. Her left leg ached up into her hip, she had fever 99.9, continued to 10Jan2021 with malaise, HA, eye pain, intermittent nausea. The events had not yet resolved at the time of report.
51 2021-01-21 palpitations 0805 Felt confused , heart pounding, lightheadness. BP 180/102 0809 911 called 0810 160-90 0816 Para... Read more
0805 Felt confused , heart pounding, lightheadness. BP 180/102 0809 911 called 0810 160-90 0816 Paramedics arrived, Hx of panic attacks that precipitate ED visit, not on any meds.
51 2021-01-21 fast heart rate, chest discomfort, hypertension Received the Pfizer COVID-19 vaccine this morning and, while walking back to work, experienced hyper... Read more
Received the Pfizer COVID-19 vaccine this morning and, while walking back to work, experienced hypertension, tachycardia, diaphoresis, shortness of breath, anxiety and chest discomfort. Code Blue was called; she received supplemental oxygen and was given Aspirin 81 mg. Emergency Medical Services (911) were contacted and arrived at 11:45 AM. She was assessed and an intravenous line was inserted. She was transported to an emergency room and left this facility at 12:20 PM. Update: The employee was assessed and treated at Hospital. She was not admitted; she was directed to follow up with her primary care provider and to seek a referral to a cardiologist.
51 2021-01-21 heart rate increased, blood pressure increased Swollen on injection site (about 2inches circumference) blood pressure and hear rate elevated (153/1... Read more
Swollen on injection site (about 2inches circumference) blood pressure and hear rate elevated (153/103 pulse99) -patient refused to call 911 and asking staff to drive to hospital at 9:45am. hospital and nurse in charge at the facility, has contacted each other. At 11:46am nurse has inforemed me that hospital provided IVBenadryl/Fluid IV/Epipen, her heart still raised up, and has twitching, patient has left hospital and back to facility at 12:20pm
51 2021-01-21 blood pressure increased Throbbing pain R. Clavicle, shaking hands, Flushing, increased B/P
51 2021-01-21 hypertension, fast heart rate, chest discomfort received the Pfizer COVID-19 vaccine this morning and while walking back to work, experienced hypert... Read more
received the Pfizer COVID-19 vaccine this morning and while walking back to work, experienced hypertension, tachycardia, diaphoresis, shortness of breath, anxiety and chest discomfort. Code Blue was called; she received supplemental oxygen and was given Aspirin 81 mg. Emergency Medical Services were contacted and arrived at 11:45 AM. She was assessed and an intravenous line was inserted. She was transported to an emergency room and left this facility at 12:20 PM. Update: was assessed and treated at Hospital. She was not admitted; she was directed to follow up with her primary care provider and to seek a referral to a cardiologist.
51 2021-01-22 fast heart rate Chills, muscle aches and weakness, headache, tachycardia
51 2021-01-22 nosebleed, fainting I had a syncope on Wednesday night with a nose bleed. I also had bleeding from the back up from my t... Read more
I had a syncope on Wednesday night with a nose bleed. I also had bleeding from the back up from my throat. My family called 911 and at home the paramedics checked blood sugar, blood pressure and said everything looked ok.
51 2021-01-23 palpitations Dizziness, headache and mild palpitations lasting for two days. Took Tylenol and stayed in Bed
51 2021-01-24 lightheadedness short of breath; lightheaded, dizzy, like pre-syncope as I felt like I could pass out but did not do... Read more
short of breath; lightheaded, dizzy, like pre-syncope as I felt like I could pass out but did not do so; lightheaded, dizzy, like pre-syncope as I felt like I could pass out but did not do so; This is a spontaneous report from a contactable nurse (patient herself). A 51-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1284; expiry date: unknown) via an unspecified route of administration in the left arm, on 03Jan2021 at 10:00, at a single dose, for covid-19 immunization. Medical history included known allergies (unspecified). The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in a doctor's office/urgent care. The patient experienced 3 "waves" or what her many coworkers were describing as "whooshes". The first two occurred minutes apart approximately 4-5 minutes post vaccine-last less than one minute each. The 3rd wave occurred after lunch approximately 3 hours later-lasted approximately 2 hours but not as intense as the first times. The patient further described the symptoms as "felt like a rush" (unspecified) experienced when receiving epinephrine. She was short of breath, lightheaded, dizzy, like pre-syncope as she felt like she could pass out but did not do so. The events occurred on 03Jan2021. The patient did not receive treatment for the events. The patient recovered from the events on an unspecified date. The patient has not been tested for COVID-19 since vaccination.
51 2021-01-25 atrial fibrillation Mild myalgias and headache the day after. On Saturday, January 23rd, I had an hour+long episode of ... Read more
Mild myalgias and headache the day after. On Saturday, January 23rd, I had an hour+long episode of Atrial fibrillation. While I have had other cardiac dysrhythmias throughout my adult life, this is the first time I have had diagnosed Afib. I took one dose of my PRN Propranalol (10mg) orally after a few minutes of the abnormal rhythm. When it didn't convert, I did go to the Emergency Department. My heart converted to normal sinus rhythm while on the monitor but before any other interventions were needed. I have a follow up appointment with my cardiologist tomorrow to determine further care as needed.
51 2021-01-25 heart rate increased, hypertension, palpitations about 15 to 17 minutes after vaccine I got a warmth thru my whole body and my heart started racing. ... Read more
about 15 to 17 minutes after vaccine I got a warmth thru my whole body and my heart started racing. I also had a headache. I was taken back to medic area and was assessed. My oxygen was good but my pulse and BP were high. I layed down and after 10 minutes felt better and my pulse recovered. Shortly later I was told I could go home. I sat up and felt briefly dizzy then my heart started racing again (pulse 137). I layed back down and EMS was called. By the time they arrived my pulse had slowed to normal but I still had a headache. This was about 45 min after vaccine. They performed an EKG and monitored my vitals as I sat up and then stood up. I did not have any incidents of my heart racing but my BP was 157/98 so I was told they could take me to EC for monitoring or to my doctor. I chose to go to my doctors. I arrived at my doctor an hour later and still had elevated BP and headache . He chose to monitor me. I had another incident where my heart started to race so he gave me liquid Benadryl and let me rest. I think I had one more milder incident of my heart racing but it was not as strong. After about 3 hours I went home and was told to monitor for Anaphylaxis. I went home and slept 3 hours and woke up feeling fine. I was fatigued for next 3 days but not issues with heart. About day 5 I was working and had a couple of incidents where I felt my heart pick up a little bit and I couldn't catch my breath. After that I feel like I was fine and don't remember any more incidents.
51 2021-01-25 blood pressure increased, chest discomfort, palpitations warmth in the chest; heart began to race and BP elevated. started to feel discomfort in chest and t... Read more
warmth in the chest; heart began to race and BP elevated. started to feel discomfort in chest and tightness in throat but did not close up. Was given Benadryl and Steiroid. chest x ray given which was normal. EKG taken which was abnormal but told was consistent with an older EKG. Was feeling better and about 90 minutes later felt warmth over my heart, my lips and mouth became tingly and both arms went numb and uncertain if my heart monitor showed abnormal. Was admitted overnight for observation. About 10 hours later had warmth in my chest, heart started beating fast, numbness in arms and around mouth and slight tightness in throat. Benadryl administered and heart calmed after couple of minutes, numbness went away after couple of minutes and tightness in throat went away after an hour. Again about 13 hours later the warmth in chest and heart racing only symptoms. Given another dose of Benadryl. The symptoms only lasted a couple of minutes. I also saw a cardiologist who ordered an echocardiogram just to rule out anything with my heart. It was normal. I was sent home with instructions to use Bendryl oral for 3 days every 12 hours. I was told it could be from vaccine and I was to follow symptoms for 2 weeks and if not better to see cardiologist to look at other reasons. I have taken the Benadryl for 3 days every 12 hours and did not have any other episodes with my heart. I am on day 6 now and I have joint pain and headache.
51 2021-01-26 blood pressure increased, heart rate increased About 5-10 min after injection, I started to feel a little bit shaky and I felt my heart rate had i... Read more
About 5-10 min after injection, I started to feel a little bit shaky and I felt my heart rate had increased a lot. I just did not feel myself, out of sorts. Paramedics checked my heart rate, pulse ox and BP. O2 was normal - I did not have any respiratory symptoms. My heart rate was quite elevated and blood pressure as well. They had me come to the ambulance to monitor me for a bit longer. Around the injection site I had a large ring of hives, it was red and quite warm. I was red and warm also on my neck and somewhat on the top of my back. They hooked me up to EKG, took my blood pressure, pulse ox and heart rate again, BP and heart rate were still high, O2 sats were normal, but I was feeling better. We waited 15 minutes approximately and they checked my vitals again and my blood pressure has down, as well as my heart rate. So they felt it was OK to discharge me with instructions to take an antihistamine when I got home, and to call emergency services if I needed further help. My symptoms all subsided completely and I was fine at home.
51 2021-01-26 heart rate increased Noticed heart rate elevated on day of vaccine (1/26/21) w/ slight dizziness. My heart rate is rangin... Read more
Noticed heart rate elevated on day of vaccine (1/26/21) w/ slight dizziness. My heart rate is ranging from 130s-180s, becoming more elevated with activity. At rest it's varying from 90s to 130s. It is now 1/27/21 at 8:50am and symptoms have continued.
51 2021-01-26 chest discomfort metallic taste in throat; mid chest tightness and weakness; flushed feeling in body and legs; went t... Read more
metallic taste in throat; mid chest tightness and weakness; flushed feeling in body and legs; went to the emergency room since she didn't feel any better; mid chest tightness and weakness; This is a spontaneous report from a contactable nurse (patient). A 51-year-old female patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EK5730, expiration date: Mar2021), via an unspecified route of administration on 30Dec2020 12:00 at single dose on deltoid left for COVID-19 immunisation. Medical history included patient was working in healthcare and around Covid positive patients daily. There were no concomitant medications. 10 minutes after getting bnt162b2, patient noticed side effects. Patient had a metallic taste in throat and a few more things. Right after getting it she had a flushed feeling in her body and legs, similar like IV contrast. 10 minutes after that so about 20 minutes later she had mid chest tightness and weakness that was gone after about 40 minutes to an hour. Patient was unable to provide any seriousness criteria, stating it was scary for a moment and she didn't know what it was, but the mid chest tightness could have progressed to something more serious. That was how she felt at that moment, but after it was all gone, it was not serious. She did not know why or what the reason was or if she was lucky or what. Patient was sitting for 10 minutes after receiving Pfizer COVID vaccine and was doing something on her phone when she started experiencing these symptoms unexpectantly. Eventually the nurses observing her after a half hour took her to the emergency room since she wasn't feeling any better. Patient had emergency room visit for all events. Outcome of events was resolving.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported mid chest tightness and the administration of the COVID 19 vaccine, BNT162B2, based on the plausible temporal association and lacking alternative explanations. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
51 2021-01-26 hypertension nausea, vomiting, burning in the stomach, itching in the throat., I couldn't talk. high blood pressu... Read more
nausea, vomiting, burning in the stomach, itching in the throat., I couldn't talk. high blood pressure. I was administered solumedrol intravenous, Benadryl intravenous, Pepcid intravenous and Zofran sublingual and NSS 0.9 to 10 ml per hour.
51 2021-01-27 hypertension, chest discomfort, heart rate irregular Chest tightness and irregular heart rhythm. Elevated blood pressure
51 2021-01-28 heart rate increased Elevated heart rate at 7pm on evening of vaccine (administered at noon); tingling sensation all over... Read more
Elevated heart rate at 7pm on evening of vaccine (administered at noon); tingling sensation all over; This is a spontaneous report from a contactable pharmacist (patient). A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142) intramuscularly at right arm on 14Jan2021 12:00 at single dose for COVID-19 immunization. Medical history included none. No known allergies. The patient's concomitant medications were not reported. The patient experienced elevated heart rate at 7pm on evening of vaccine (administered at noon), tingling sensation all over. Laid down and issue resolved within 2 hours. No treatment received. No other vaccine in four weeks. No other medications in two weeks. No covid prior vaccination. No covid tested post vaccination. The outcome of the events was recovered on 14Jan2021.
51 2021-01-28 heart rate increased Pt came to clinic for Covid-19 vaccine. Allergies reviewed. Pt had seen allergist for allergic reac... Read more
Pt came to clinic for Covid-19 vaccine. Allergies reviewed. Pt had seen allergist for allergic reaction associated with treatment of kidney stones. Allergist believed reaction was related to flomax or oxycodone (neither of these are injectable therapies. Vaccination given. Pt came to staff during the waiting period stating starting just minutes after the vaccination she started feeling of "dry throat." She also noted her heart beat was a little fast. No shortness of breath, no hives or any other signs of reaction. Pt was given diphenhydramine 25 mg orally at 1305. At 1325 Pt reports she is feeling better (she is conversing with friend and laughing). She states she will leave here and f/u with allergist regarding whether or not she should receive 2nd vaccination dose.
51 2021-01-28 heart rate increased cold frostbite like hands and feet; dizziness when warmed up too quickly; racing heart rate; trouble... Read more
cold frostbite like hands and feet; dizziness when warmed up too quickly; racing heart rate; trouble finding words; extreme fatigue; nausea; achiness at joints; swollen lymph nodes; This is a spontaneous report from a contactable nurse (patient herself). A 51-year-old female patient (not pregnant at time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EL0140, expiry date unknown), via an unspecified route of administration (vaccine location: left arm), on 23Dec2020 17:00, at single dose, for covid-19 immunization. The patient had no medical history. There were no concomitant medications. The patient experienced cold frostbite like hands and feet, dizziness when warmed up too quickly, racing heart rate, trouble finding words, with extreme fatigue, nausea, achiness at joints, and swollen lymph nodes - all on 24Dec2020. These symptoms never left up until day 21 when the patient received her next shot. The patient had no other vaccine in four weeks, had no other medications in two weeks, had no Covid prior vaccination, and had not been Covid-tested post vaccination. It was unknown if treatment was received for the adverse events. The patient was recovering from the events.
51 2021-01-28 lightheadedness, fainting patient had a vagal response and partial syncope episode minutes after vaccine was administered. Pat... Read more
patient had a vagal response and partial syncope episode minutes after vaccine was administered. Patient did not recover so 911 was called and ems arrived to take to the emergency room
51 2021-01-29 fast heart rate Patient began to feel hot, vital signs were assessed and patient was found to be tachycardic and flu... Read more
Patient began to feel hot, vital signs were assessed and patient was found to be tachycardic and flushed. Given history of other allergic reactions and rapid onset of symptoms, patient was sent to the ED for additional f/u.
51 2021-01-30 palpitations Throat closing, palpitation, lightheadedness, cough with bronchospasm
51 2021-01-31 chest discomfort 10 days after 1st injection, I started having symptoms. Cough, chest tightness, fever, body aches, ... Read more
10 days after 1st injection, I started having symptoms. Cough, chest tightness, fever, body aches, chills, etc.12 days after 1st vaccine, I tested Positive for COVID-19.
51 2021-01-31 palpitations 1250: presents with heart racing, HR: 144, BP: 142/90, Upper lip numbness, throat tightening, felt f... Read more
1250: presents with heart racing, HR: 144, BP: 142/90, Upper lip numbness, throat tightening, felt flush, complained of dryness to throat, drank a glass of water and tolerated Rapid response called; transferred to Ed
51 2021-01-31 palpitations malaise/ feeling of severe unwell; migraine; neck pain; heart racing; blurry vision; muscle spasms; ... Read more
malaise/ feeling of severe unwell; migraine; neck pain; heart racing; blurry vision; muscle spasms; muscle pain; nausea; dizziness; swollen entire left arm injection arm; joint pain; kidney pain; unable to think clearly; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), via an unspecified route of administration on 13Jan2021 12:00 PM at a single dose on left arm for COVID-19 immunization. The patient medical history was not reported. No known allergies. There were no concomitant medications. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), via an unspecified route of administration on 23Dec2020, 05:00 PM at a single dose on left arm for COVID-19 immunization and experienced cold frostbite like hands and feet, dizziness when warmed up too quickly, racing heart rate, trouble finding words, with extreme fatigue, nausea, achiness at joints, and swollen lymph nodes. The patient experienced malaise, feeling of severe unwell, migraine and neck pain, heart racing, blurry vision, muscle spasms, muscle pain, nausea, dizziness swollen entire left arm injection arm, joint pain, kidney pain, unable to think clearly on 14Jan2021. AE resulted in Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of muscle pain and nausea. The outcome of the events was recovering. The patient was not pregnant. No other vaccine in four weeks. Not diagnosed with COVID prior vaccination. Not tested for COVID post vaccination.
51 2021-02-01 blood pressure increased Systemic: Headache, Systemic: Other- Staff Member complained of metallic taste and headache. Instruc... Read more
Systemic: Headache, Systemic: Other- Staff Member complained of metallic taste and headache. Instructed to lay down, BP was elevated, continued to rise. Contacted 911, patient transported to hospital, admitted and disharged next day. Symptoms lasted 1 day
51 2021-02-02 blood glucose increased, hypertension, hypotension **Pfizer-BioNTech COVID-19 Vaccine EUA** 1/25/2021 - was found unresponsive with left upward gaze de... Read more
**Pfizer-BioNTech COVID-19 Vaccine EUA** 1/25/2021 - was found unresponsive with left upward gaze deviation at midnight and admitted to hospital (last seen normal around 7 pm 1/24/2021). Intubated in ED, ABG 6.98/17/186 on 40%, Bicarb <5, Scr 1.4, Lactate 1, Wbc 20.3, BP 101/45-- >95/41, Temp 94.3, RR 23-32. Acidotic and initially required norepineprine for hypotension management (stopped 1/26/2021 0400 am) 1/26 to 2/1/2021 - supportive care for encephalopathy (anoxic vs. ischemic brain injury), ARF, HTN, MSSA growth in resp culture (no respiratory distress, on antibiotic) 1/28 GCS:E4VTM4; 1/29 GCS: EV4VTM4 with intact protective reflexes, extubated 2 pm 2/1 arousable, follows very simple commands, non verbal
51 2021-02-02 hypertension On Friday, 1/29, after receiving the vaccine, I experience a headache, sharp right side pain in my n... Read more
On Friday, 1/29, after receiving the vaccine, I experience a headache, sharp right side pain in my neck, jaw, and ear. On Saturday, 1/30, I woke up, and the right side of my face was numb, and my right eye would not blink. I went to ER. When they took my vitals, I had high blood pressure and fever. They did a CT scan of my head and admitted me. I was diagnosed with Bell's Palsy. I was discharged on Sunday, 1/31, with medications: Valacyclovir 1 gram three times a day and Prednisone 20 mg three times a day. I was instructed to followup with a neurologist, immunologist, ophthalmologist, and my primary care physician.
51 2021-02-03 palpitations Heart palpitations during the night of 1/29/2021. Resolved by the next day.
51 2021-02-03 chest discomfort Hot feeling on arm. Itchy all over my body. Mainly on arms and trunk, ears face nose. neck head... Read more
Hot feeling on arm. Itchy all over my body. Mainly on arms and trunk, ears face nose. neck head . Heavy feeling in chest. Pain around ribs stomach area an hour after shot. Pain in area of shot. Headache and ache in shoulder of arm with shot. Back ache.
51 2021-02-03 chest pain, chest discomfort Next day 15Jan2021.wake up with flu like symptoms: Aches. Pain .nausea. Tire. Little Stomach cramps ... Read more
Next day 15Jan2021.wake up with flu like symptoms: Aches. Pain .nausea. Tire. Little Stomach cramps needle like feeling. .Headache. Little dizziness.over all not feeling well.; Next day 15Jan2021.wake up with flu like symptoms: Aches. Pain .nausea. Tire. Little Stomach cramps needle like feeling. .Headache. Little dizziness.over all not feeling well.; Next day jan 15Jan2021.wake up with flu like symptoms: Aches. Pain .nausea. Tire. Little Stomach cramps needle like feeling. .Headache. Little dizziness.over all not feeling well.; Next day 15Jan2021.wake up with flu like symptoms: Aches. Pain .nausea. Tire. Little Stomach cramps needle like feeling. .Headache. Little dizziness.over all not feeling well.; Next day 15Jan 2021.wake up with flu like symptoms: Aches. Pain .nausea. Tire. Little Stomach cramps needle like feeling. .Headache. Little dizziness.over all not feeling well.; Next day15Jan2021.wake up with flu like symptoms: Aches. Pain .nausea. Tire. Little Stomach cramps needle like feeling. .Headache. Little dizziness.over all not feeling well.; over all not feeling well; Burning feeling around sternum area; Next day 15Jan2021.wake up with flu like symptoms: Aches. Pain .nausea. Tire. Little Stomach cramps needle like feeling. .Headache. Little dizziness.over all not feeling well.; 2 hrs after vaccine. Felt like multiples needles like shooting to both side of sternum.; This is a spontaneous report from a contactable health care professional nurse, the patient (patient). A 51-years-old non-pregnant female patient (nurse) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL3249), via an unspecified route of administration in the left arm from 14Jan2021 16:45 as a single dose, for COVID-19 vaccination. Facility where the most recent COVID-19 vaccine was administered was a Hospital. The patient medical history was not reported. There were no concomitant medications. The patient had no allergies to medications, food or other products. Historical data includes patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EJ1685), on 23Dec2020 at 16:00 in left arm for Covid-19 Immunisation. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 14Jan2021 (2 hrs after vaccine) the patient experienced felt like multiples needles like shooting to both side of sternum. No others symtoms. On the next day 15Jan2021 the patient woke up with flu like symptoms: aches. pain .nausea. tired. little stomach cramps needle like feeling, headache. little dizziness. over all not feeling well. Burning feeling around sternum area. No treatment was given for the events.. However, it was also stated 'Took 2 tylenol symptoms. Remains. I slept off most of the time.'. Clinical outcome of the events Felt like mutiples needles like shooting to both side of sternum, flu like symptoms: Aches. Pain .nausea. Tired. Little Stomach cramps needle like feeling.. Headache. Little dizziness. Over all not feeling well. Burning feeling around sternum area was reported as unknown
51 2021-02-03 chest pain Severe itching and hives, shortness of breath causing chest pain
51 2021-02-03 atrial fibrillation Shortness of breath , atrial fib, body aches and fever
51 2021-02-03 chest pain, chest discomfort This employee sent me an email on 12/23/20. "Subject: Re: Attention Covid Vaccine Volunteers Hell... Read more
This employee sent me an email on 12/23/20. "Subject: Re: Attention Covid Vaccine Volunteers Hello, I had received my vaccine earlier today and just awoken to chest pains. I do not think it wise to be there for my shift in the next 8 hrs. I will stay and observe for additional symptoms. I was on vacay and had out-of-office notice set for my email. I discovered this email yesterday while catching up on emails. I immediately called her. She described the details of the events; stated she has not sought medical care; all symptoms resolved spontaneously but still has some intermittent, mild SOB> She sent me this email describing the reaction: Here explanation of the reaction: Thank you for the follow up. Below is a list of symptoms I experienced after I received my initial dose of the Pfizer vaccine. I am scheduled to receive my 2nd dose next week on the 13th of January. following up: I received my shot at 8:15 am, within approximately 45 min I felt a very slight heaviness to my breathing something similar to allergy season breathing, and a slight headache on my rt temple. This was nothing that stopped me or slowed me down that day. At ~ 10:30pm I awoke from a deep sleep with SHARP chest pains, at 11pm chills, 1am fever and discomfort, 2am muscle aches. I slept on my left side to keep blood circulating to my heart which seemed to ease some of my discomfort. My first night was rough. I awoke Thurs (12/24) with a swollen left foot and leg. some rt leg pain, joint pain in my left knee. I pushed myself to get up and move and go about my day. Friday, I still had a little left foot swelling and pain, knee pain, but kept pushing. The handout says if symptoms persist for longer than 24-48 to seek medical care, I have not. Friday, (12/25/20)was Christmas and much of the day was non eventful. At ~ 530pm. I felt a bulging not in the center of my chest which was tender to the touch. This concerned me. I gently messaged the area, rested a bit but continued to move up and down the stairs. That discomfort and the bulge decreased within a few hours. Saturday, (12/26) 4:am and I noticed much of the swelling in my foot and legs has decreased, however, I now have bruising. The sore arm is gone, and I am hopeful that all is well. I forgot to mention, I have had intermittent persistent cough with slight sob, something similar to the start of allergy season, but it is brief. I have been coughing at night." I advised she contact her PCP to determine if follow up is indicated given persistent, intermittent cough and SOB.
51 2021-02-04 palpitations, chest pain FEVER, SWEATS/CHILLS, FATIGUE, FLUTTERING, PALPITATIONS, HEADACHES, WEAKNESS, SHORTNESS OF BREATH, C... Read more
FEVER, SWEATS/CHILLS, FATIGUE, FLUTTERING, PALPITATIONS, HEADACHES, WEAKNESS, SHORTNESS OF BREATH, COUGH, LOWER ABDOMINAL PAIN, MUSCLE PAIN, CHEST PAIN. PAIN AND SWELLING AT INJECTION SITE.
51 2021-02-04 fast heart rate Pt c/o tachycardia, v/s taken HR = 108 Reg, BP= 110/80 @ L arm. BP checked again after 15 mins 120/8... Read more
Pt c/o tachycardia, v/s taken HR = 108 Reg, BP= 110/80 @ L arm. BP checked again after 15 mins 120/80. Resolved after 15mins. States relief and d/c in no distress. Advised to notify PCP or go to ED any problems arises. Did not have any recurring or residual effects after tachycardia resolved.
51 2021-02-04 chest pain, palpitations pt with sudden onset chest pain and palpitations after event.
51 2021-02-07 heart rate increased Patient experienced tingling in throat/neck area, and had elevated HR (patient attributes to anxiety... Read more
Patient experienced tingling in throat/neck area, and had elevated HR (patient attributes to anxiety). Monitored for 60 minutes and drank some water. Started to feel better. Patient said she experienced this after her first dose, but not until after she left the clinic. She said that time it resolved within 12 hours. Patient said she felt well enough to leave and said she'll seek medical help if symptoms don't resolve or worsen.
51 2021-02-07 pallor RN was called over to case, upon arrival, case was pale, diaphoretic, nauseated. Attempted to ask c... Read more
RN was called over to case, upon arrival, case was pale, diaphoretic, nauseated. Attempted to ask case name twice, she did not respond, case was began ?snoring? for roughly 3 breaths, then began dry heaving, which produced minute amount of blood tinged phlegm. At this time, case was able to tell me her name and was able to remember that she had just received her vaccine. Per her mother and guardian, case has history of mental disabilities and allergy to oral penicillin. Case also has history of childhood seizures that were so mild, she is not on medication. Case requested to be taken to ED for evaluation.
51 2021-02-08 hypotension yesterday started a flare up but she is not sure if this is related to the vaccine use; fever/was 10... Read more
yesterday started a flare up but she is not sure if this is related to the vaccine use; fever/was 105.00 with Tylenol; increased dizziness/light-headed; body aches; severe headache; nausea; chills; sweating/sweats; Fatigue; feeling crappy; blood pressure tends to be low but was 95/81 at the time she got the shot; The initial case was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on 25Jan2021 this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer. A 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3247, expiration date was not reported), via an unspecified route of administration on 19Jan2021 17:45 at single dose on the left arm for COVID-19 immunization. Medical history included ongoing severe Crohn's disease, pneumonia, allergy to eggs/anaphylactic reactions to eggs, anaphylactic with bee stings on 2020 (this has happen twice in 2020), collapsed her lung (reaction to anesthesia that collapsed her lung), high fever, anaphylactic reactions. Concomitant medication included sertraline (SERTRALINE), cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]). The patient previously took Hep B and experienced fever, flu like symptoms, achy, and lethargic (no issue with the first 2 doses but with the 3rd dose she had a high fever); MMR and had an adverse reaction. It was reported that the shot was given on 19Jan2021. She experienced the following severe dizziness which started that day (17:45) and lasted 3 days. It has resolved. Nausea which started that day (17:45) and stayed constant for 3 days. Now it has only been happing in the late afternoons or evenings. Light headed which started that day and last 3 days. Headache (17:45), the initial headache felt like her whole head was going to explode into a 1000 piece. Now it just starts about 4-5pm in the evening. It was better and not as severe but like a migraine with nausea (17:45), feeling crappy (17:45), and body aches. Body aches which started on the day of the shot (17:45) and lasted 3 days. Fatigue which started on the day she got the shot (17:45) and was ongoing in the evening now chills and sweats which started on the day she got the shot and was ongoing. Her husband asked about if this was being related to the change of life but she doesn't think so. Fever which happened on the day she got the shot (17:45) but not at the site, later that night and was 105.00 with Tylenol. It has resolved. She noted that her blood pressure tends to be low but was 95/81 at the time she got the shot (17:45). The patient has not taken her blood pressure and does know if this has resolved. It was relayed that she took Tylenol and Benadryl before the shot due to her history and was still taking it as treatment for the symptoms. She has a lot of drug and other allergies, the only that was anaphylaxis was bees and egg. This was why she brought 2 EpiPens when she had the shot. She didn't have to use her EpiPen and was really proud of that but did have some reactions. The patient reported she did not go to the doctor. At this point she was somewhat expected that she had a not great reaction so the fact that she could still breath after getting it was a good thing. She also noted she could not have driven home due to dizziness. The patient was not brought to the emergency room and did not went to a physician's office. The patient has an ongoing medical history of Crohn's disease and reported that yesterday (as reported) started a flare up but she was not sure if this was related to the vaccine use. The patient recovered from fever on 23Jan2021; was recovering from dizziness, body aches, severe headache, nausea, chills, sweating, and fatigue; while outcome of blood pressure tends to be low, feeling crappy and Crohn's flare up was unknown.
51 2021-02-09 palpitations, hypertension, heart rate increased Systemic: Other- High blood pressure (198/123) pulse (106bpm), palpitation -Medium
51 2021-02-14 platelet count decreased, haemoglobin decreased Patient received dose #1 of COVID-19 vaccine on 1/16/21. Within 3 days, she developed petechiae up t... Read more
Patient received dose #1 of COVID-19 vaccine on 1/16/21. Within 3 days, she developed petechiae up to ankles, later rising up to her knees. Pt admitted to hospital on 2/6/21 for symptomatic anemia 2/2 vaginal bleeding. Patient received 4 units FFP, 4 units PRBC, 1 unit cryoprecipitate, and vitamin K 5 mg IV. Also started on medroxyprogesterone 20 mg PO TID. Alectinib d/ced due to worsening liver function. Evalauted by OB/GYN and Hematology. Diagnosed with DIC. Patient with worsening bilateral lower extremity edema and purpura with pain and weakness. Palliative care consulted. Patient passed away on 2/11.
51 2021-02-21 chest discomfort Difficulty swallowing within minutes of vaccination. no progression of this symptom and also develo... Read more
Difficulty swallowing within minutes of vaccination. no progression of this symptom and also developed a mild headache to base of skull. chest feels a little tight. 12.5 mg of Benadryl given about 30 minutes in to observation. After another 50 minutes, headache gone, chest pressure less, and swallowing improved. patient advised to return to ED if symptoms returned or worsened.
51 2021-02-21 nosebleed Received her 1st covid vaccine at noon on 2/19/21. Woke later that night in middle of the night wit... Read more
Received her 1st covid vaccine at noon on 2/19/21. Woke later that night in middle of the night with bleeding from right nostril and severe right ear pain
51 2021-02-21 blood pressure increased Ten minutes after, I had sharp pain on my left temporal and they took my vitals. BP was elevated. Th... Read more
Ten minutes after, I had sharp pain on my left temporal and they took my vitals. BP was elevated. They asked me what are my allergies and medical history. I couldn't remember - so had brain fog at that time. My left ear, face, and neck (left side of head) is numb at that time. The symptoms were the same for two hours. Memory remained fogged. An hour or so after the incident - I called the advice nurse from medical clinic and I did remember the doctor's name. Pain on head and numbness remained for days. My auto-immune system was stimulated my doctor said. Everything kept cascading down - now I'm on post surgery 9 days and I'm on disability. I went to ER on January 18, I was complaining of left sided numbness, vomiting, headaches. Facial numbness (left), mild headaches. Left sided headache progressed to (similar to prior migraine headaches) migraine like. January 29, I emailed my physicians (in between the 17th and 29th). On the 29th, I went to see the doctor - joints - really swollen and painful and I cannot walk. I was given steroid shots. February 2, - appt with neurologist. February - with Dr. - for painful swollen feet; Feb 10 - appt with Rheumotologist - Feb 10 with Dr - a Specialist - , as well. Right foot is swollen as well as the left foot at this time. Dr. - axperatated the right ankle -he said it was infected. February 11, Dr said I have infected joints and need surgery. They did surgery on February 13th. Dr. the surgeon . Had surgery at medical facility for infected ankle. February 15 - discharged home. Appt with surgeon on the 16th. Appt with Primary on the 19th. Appt with my Rheumotologist today. Discharged - with Home Health care; Physical and Occupational therapist and nursing. I have been on bedrest since discharge. I need maximum care. Tomorrow I have a appt with surgeon to hopefully remove cast and sutures on surgical site.
51 2021-02-22 palpitations Palpitations 18 hours after vaccine
51 2021-02-23 chest pain 6 DAYS AFTER THE SHOT I GOT JOINT PAIN AND MUSCLE PAIN TO THE POINT OF NOT BEING ABLE TO WALK. HAD S... Read more
6 DAYS AFTER THE SHOT I GOT JOINT PAIN AND MUSCLE PAIN TO THE POINT OF NOT BEING ABLE TO WALK. HAD SEVERE STOMACH PAIN, CHEST HURT WAS NOT ABLE TO DRAW A DEEP BREATH. RAN A FEVER OF 102.5 OFF AND ON.
51 2021-02-23 blood pressure increased Pt received dose #1 of Pfizer vaccine at 12:48 PM. After about 10-12 min wait period in waiting are... Read more
Pt received dose #1 of Pfizer vaccine at 12:48 PM. After about 10-12 min wait period in waiting area, c/o feeling "whoozy", a metallic taste in mouth and tingling of mouth. A short time later, reports that symptoms are worsening. Walked with stand by assist of two to cot. BP elevated, other VSS. C/o feeling "whoozy", middle tongue feeling swollen, metallic taste in mouth, mouth feeling numb/tingling. Symptoms progressed to rest of body feeling "tingling". Denies dizziness. Symptoms progressing. Denies SOB, itchy throat or throat swelling sensation. Denies any itching of skin. No hives or rash noted. Due to worsening of symptoms, a First Responder was called at 2:01 PM for transport, monitoring and treatment in ED.
51 2021-02-24 blood pressure increased She did not have any reactions to the first dose; however, this dose made her feel lightheaded, dizz... Read more
She did not have any reactions to the first dose; however, this dose made her feel lightheaded, dizzy, and nauseas. She felt "off" to the point of tears. EMS took a look at her and her blood pressure was elevated. When she developed a rash the decided to transport her to the hospital for further evaluation. She was given Benadryl 12.5mg PO before she left the clinic. They started an IV for the patient but did not hook any medications or fluids up at the time.
51 2021-02-25 chest discomfort At the vaccine administration location, patient experienced the following symptoms: tightness in che... Read more
At the vaccine administration location, patient experienced the following symptoms: tightness in chest, tightness in throat, nausea, ithcy tingley lips, burning lips, bumps/gives on inside of lips. Patient given diphenhydramine 25 mg oral solution PO x1. Vitals taken: WNL. Patient denied EMS transport to ER and transported self to ER. Per ED Provider Notes: Patient reports vaccine was given about 1.5 hours prior to arrival. Pt reported sensation of swelling of her arms, left eye itchiness, and itchiness on the inside of her lips. She denied any difficult, no abnormal sensation in her throat, throat swelling or swelling elsewhere in her mouth. Pruritus documented, no rash. Nausea. At the time of the ER provider examining patient. it is reported that patient was not having anaphylaxis but does have a flat appearing raised lesions on side aspect of upper lower lip. Pt treated with IV diphenhydramine, PO Prednisone and IV famotidine along with NS. Patient observed for 2.5 hours and then discharged. No swelling, itching or swelling and time of discharge and reports resolution of symptoms.
51 2021-02-25 chest pain Patient presented to the ED due to shortness of breath and chest pain stating that the symptoms deve... Read more
Patient presented to the ED due to shortness of breath and chest pain stating that the symptoms developed yesterday after receiving COVID-19 immunization. Patient stated that she has taken multiple albuterol and Benadryl doses yesterday. Pain is located at the center of the chest and bilateral ribs (right more than left). When taking deep breaths the pain increases.
51 2021-02-25 chest pain stabbing chest pain on left side, occasional belching -- still exists currently
51 2021-02-27 hypertension 10 days after vaccine I all of a sudden developed extremely high blood pressure of 175/100. Went to ... Read more
10 days after vaccine I all of a sudden developed extremely high blood pressure of 175/100. Went to doctor and he also took blood pressures and still was in the 178-180 range. Never had high blood pressure in my life. Also experienced a broken blood vessel in my eye in between first shot and second shot.
51 2021-02-27 blood glucose increased Elevated blood sugar levels beginning 6 hours after injection; Diarrhea multiple times 5 hours after... Read more
Elevated blood sugar levels beginning 6 hours after injection; Diarrhea multiple times 5 hours after injection; Fever of up to 102.5 starting 12 hrs after injection; Chills and shaking starting 12 hrs after injection; Very swollen and tender lymph node above clavicle noticed approximately 42 hours after injection; Muscle and joint pain
51 2021-02-28 heart rate increased A little nauseated following injection. By that afternoon felt very ill. Took Tylenol and went to be... Read more
A little nauseated following injection. By that afternoon felt very ill. Took Tylenol and went to bed. Basically slept for the next 36 hours. High fever?Tylenol only brought down slightly and back up within a few hours, severe headache that Tylenol didn?t help, nausea to point of unable to eat or drink because felt like going to puke, dizziness whenever tried to get up, would also get short of breath whenever tried to get up, raised heart rate, fatigue?I was so out of it that my husband had to occasionally wake me to make sure I was still responsive, terrible body aches to the point that it hurt to move.
51 2021-02-28 hypertension, fainting, palpitations I experienced bizarre symptoms after my first dose. I had a near syncopal episode, heart palpitation... Read more
I experienced bizarre symptoms after my first dose. I had a near syncopal episode, heart palpitations, shortness of breath, hypertension and dizziness. I went to the ER due to my symptoms. They performed an EKG, Lab work, X-ray of the chest, Covid test-19 all which were negative. I still have these symptoms which have not gone away.
51 2021-02-28 loss of consciousness, heart attack Patient was administered the first dose in the Pfizer COVID vaccine series. During the observation p... Read more
Patient was administered the first dose in the Pfizer COVID vaccine series. During the observation portion, the patient passed out in the observation area approximately 10 minutes after receiving the dose and became non-responsive with ragged breathing. The pharmacy team responded and administered a dose of epinephrine 0.3mg to the patient immediately and called for EMS who arrived on the scene
51 2021-03-02 chest pain, fibrin d dimer increased, pulmonary embolism, fast heart rate 51 y/o female, no chronic health problems. 14 days following first COVID Pfizer vaccine, I felt unab... Read more
51 y/o female, no chronic health problems. 14 days following first COVID Pfizer vaccine, I felt unable to take a deep breath, on day 15 following the vaccine, I became short of breath,; on day 16 I was having mild chest pain with inspiration and shortness of breath; day 17 following vaccination I became significantly short of breath, with moderate to severe chest pain with inspiration and tachycardia (heart rate in the 140's). I called my PCP who ordered an EKG, CXR, COVID swab, a metabolic panel, a CBC, and a D-dimer. My D-dimer was elevated and he called me to go directly to the emergency department, which I did and had a CTA chest. I was diagnosed with multifocal pulmonary emboli in my right lung with a slight pleural effusion on my left lung. I had a duplex ultrasound of my legs which was negatve for DVT, and an echocardiogram which was within normal limits. I was finally diagnosed with acute unprovoked pulmonary embolism, given a Heparin bolus and started on a Heparin IV infusion. Ultimately, I transitioned to Eliquis PO and was discharged from the hospital within 24 hours.
51 2021-03-03 pallor, fainting Pulse weak. Thready, Lips pale, Fainted. Refused transport. Evaluated by EMS-Cleared
51 2021-03-03 chest discomfort, blood pressure increased, palpitations, chest pain half hour - itchy mouth, dizzy, lightheaded, headache (30 mins) - BP surge 151/104 (2 hours after),... Read more
half hour - itchy mouth, dizzy, lightheaded, headache (30 mins) - BP surge 151/104 (2 hours after), chest tightness, heart racing (3 hours after) - some of this went away after a while - mostly subsided (still having some chest pains and racing heart off and on) - red blotchy face, hands, bit of nausea - 1 day following
51 2021-03-04 hypertension, chest pain Sore arm, temp 99.9, headache, fatigue, dizzy, HTN, sweats, chest pain
51 2021-03-18 pallor, blood glucose increased, heart rate increased Headache; her whole left arm and left hand are sore; allergic reaction; left arm started feeling flu... Read more
Headache; her whole left arm and left hand are sore; allergic reaction; left arm started feeling flushed; her left arm started getting hot, and the hot sensation traveled down her left arm to her left hand, and up to her left shoulder and neck/her left arm was much warmer than her right arm; upper part of her left arm started turning pink, and then red; burning feeling in her left hand fingers; her left hand got numb and tingly; her left hand got numb and tingly; her fingers in her left hand became itchy/it was a deep down itch in her left hand fingers; the muscles in her left arm between the inside of her left elbow down to the inside of her left wrist were "twingey"; blood glucose was at 295 when she checked before bedtime of 17Feb2021, and at 185 before breakfast in the morning of 18Feb2021; she looked like she had hives; rash going down her left arm/clarified the blotchy red marks go in a line from the inside of her top left elbow down to her left wrist; there is a flush color around the vaccine injection site, but not on the vaccine injection site; Injection site pain/injection site is sore; left shoulder is warm to the touch around her COVID-19 Vaccine injection site; she looked completely wiped out, and pale; looked completely wiped out/Tiredness; Short of breath; her pulse was 101; This is a spontaneous report received from a contactable consumer (patient). A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200, expiry date: 21Feb2021), via an unspecified route of administration in the left arm, on 17Feb2021 15:40, as single dose, for COVID-19 immunisation. Medical history included type 2 diabetes mellitus from 2012 to (diagnosed with Type 2 Diabetes Mellitus almost 9 years ago), neuropathy in her feet/nerves and reported that she only turns pink if she gets overheated. There were no concomitant medications. The patient did not receive any prior vaccinations within 4 weeks. Historical vaccines included influenza vaccine (reported as flu vaccine) which she gets every year and pneumococcal vaccine (reported as pneumonia vaccine) which she gets every 5 years. The patient reported that she received her first Pfizer COVID-19 vaccine on 17Feb2021 and had an allergic reaction. She said she was at a podiatry appointment, and her podiatrist told her the pharmacy had an extra COVID-19 Vaccine available. She said the pharmacy staff came to her podiatrist's office to administer her COVID-19 Vaccine. She said about 5 minutes after she received the COVID-19 Vaccine injection, on 17Feb2021 15:45, her left arm started feeling flushed, her left arm started getting hot, and the hot sensation traveled down her left arm to her left hand, and up to her left shoulder and neck. She said 20 minutes later, she walked from her podiatrist's office to a nurse's station to be monitored further. She said while she was at the nurse's station, a doctor came by twice to evaluate. She clarified the upper part of her left arm started turning pink, and then red. She said her podiatrist asked her if that was a normal reaction for her. She said she told her podiatrist she only turns pink if she gets overheated. She said her left hand got numb and tingly. She said the muscles in her left arm between the inside of her left elbow down to the inside of her left wrist were "twingey". She said her podiatrist and his nurse felt both her arms, and said her left arm was much warmer than her right arm. While she was at the nurse's station being monitored, she felt short of breath. She said she wasn't sure if she was short of breath because of her nerves. She said her oxygen level was checked and it was at 99%. She said her pulse was 101, her blood pressure was 118/76, and her blood glucose finger stick test was 128. She said she was told by the staff monitoring her, she should expect her blood glucose number to skyrocket because there is a steroid in the COVID-19 Vaccine shot. She said the staff also mentioned she can expect blood glucose spikes as the COVID-19 Vaccine's steroid goes through her system. Her fingers in her left hand became itchy while she was at the nurse's station being monitored. It was a deep down itch in her left hand fingers. She said she asked for an ice pack to put on her left hand because she uses ice packs for neuropathy in her feet, and she felt an ice pack would help with the itch and burning feeling in her left hand fingers. The doctor came to look at her again and wanted to give her IV Benadryl. Then the doctor decided against the IV Benadryl because she would be too sleepy to drive home but the doctor did eventually give her an intramuscular injection of Benadryl 25mg (clarified as Diphenhydramine 25mg in a syringe) in her upper right arm. Within 5 minutes the itching in her left hand fingers calmed down, and the redness in her left arm calmed down to a pink color. She said 20 minutes later her left arm was still pink and warm. She said she was told by the doctor if her reaction moved out of the localized area of her left arm, to go to the Emergency Room, and to use an icepack, again, on her left hand. When she arrived home, her husband said she looked like she had hives and a rash going down her left arm. Her left arm was not itchy though. She clarified the blotchy red marks go in a line from the inside of her top left elbow down to her left wrist. She reported that while she was at her podiatrist's office her left arm was a solid pink. She then mentioned that when she goes out in the sun and gets overheated, she turns pink. She said from her left shoulder to left elbow was warm to the touch. She said by the COVID-19 Vaccine injection site there is a flush color around the vaccine injection site, but not on the vaccine injection site. She said the COVID-19 Vaccine injection site is sore and her left shoulder is warm to the touch around her COVID-19 Vaccine injection site. She reported there were no blotchy, red marks on her left arm on 18Feb2021. She said her left arm is a pretty normal on 18Feb2021. The nurse who monitored her after the COVID-19 Vaccine shot said she needed to report her allergic reaction. She was told she needs to let the COVID-19 Vaccine staff know of her reaction before she gets her second COVID-19 Vaccine injection, so she can be monitored closely. She took no other treatment after she returned home from receiving her COVID-19 Vaccine. She reported she had a headache on 18Feb2021, clarifying her whole head hurts, and the headache has been persisting all day. She said she experienced tiredness, as well. She said the tiredness started on 17Feb2021 and can be partially attributed to the Diphenhydramine 25mg injection she was given. Her husband told her she looked completely wiped out, and pale when she got home after getting her COVID-19 Vaccine on 17Feb2021. She said she remembers being tired when she got home because her eyes were squinty. She reported feeling more tired on 18Feb2021 and her whole left arm and left hand are sore. She clarified her blood glucose was at 295 when she checked before bedtime of 17Feb2021, and at 185 before breakfast in the morning of 18Feb2021. The patient recovered from the events "her fingers in her left hand became itchy/it was a deep down itch in her left hand fingers" on 17Feb2021; from "upper part of her left arm started turning pink, and then red" and "rash going down her left arm/clarified the blotchy red marks go in a line from the inside of her top left elbow down to her left wrist" on 18Feb2021; from "her left hand got numb and tingly", "the muscles in her left arm between the inside of her left elbow down to the inside of her left wrist were twingey", short of breath, "burning feeling in her left hand fingers" and "she looked completely wiped out, and pale" in Feb2021; was recovering from "left arm started feeling flushed"; has not recovered from "her left arm started getting hot, and the hot sensation traveled down her left arm to her left hand, and up to her left shoulder and neck/her left arm was much warmer than her right arm", "blood glucose was at 295 when she checked before bedtime of 17Feb2021, and at 185 before breakfast in the morning of 18Feb2021", "there is a flush color around the vaccine injection site, but not on the vaccine injection site", "Injection site pain/injection site is sore", "left shoulder is warm to the touch around her COVID-19 Vaccine injection site", "looked completely wiped out/Tiredness", "Headache" and "her whole left arm and left hand are sore". The outcome of the events allergic reaction, "her pulse was 101", "she looked like she had hives" was unknown.
51 2021-03-21 chest discomfort Burning sensation started in my left chest area through to the back of the left shoulder blade. Then... Read more
Burning sensation started in my left chest area through to the back of the left shoulder blade. Then a light of tightness and hard to breath in the middle of my chest near my throat. then a later that day into the next day burning sensation in the very middle of my chest.
51 2021-03-21 palpitations, chest discomfort chest was a little tight; short of breath; 04Mar2021 7 am patient felt heart palpitation which woke ... Read more
chest was a little tight; short of breath; 04Mar2021 7 am patient felt heart palpitation which woke her up. Patient's heart rate was jumping from 50-70 lasting 15 minutes/patient felt heart was racing and patient used the pulse OX which showed heart jumped back and forth from 140-150; This is a spontaneous report from a contactable Nurse (patient herself). A non-pregnant 51-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: E16198), via an unspecified route of administration, administered at Right arm on 02Mar2021 15:00 (at age of 51 years old) at single dose for COVID-19 immunisation. Medical history included: Diabetes, hypertension, asthma, vitamin D deficiency, known allergies: Serevent inhaler. No other vaccine in four weeks. No COVID prior vaccination. No COVID tested post vaccination. Concomitant medication included lisinopril, cefixime (FLEXERIL), colecalciferol (VITAMIN D). On 04Mar2021 7 am patient felt heart palpitation which woke her up. Patient's heart rate was jumping from 50-70 lasting 15 minutes. Then at 15:00, the patient felt heart was racing and patient used the pulse OX which showed heart jumped back and forth from 140-150, chest was a little tight and short of breath. No chest pain. Patient went to hospital. The patient was hospitalized in Mar2021 for all events. Patient still get heart racing on and off. AE resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. No treatment received for all events. The outcome of the events was Not recovered.; Sender's Comments: Pending the investigational results and clinical diagnosis, the company does not attribute the events palpitation, chest tight and short of breath to BNT162B2. The underlying hypertension, diabetes and asthma are considered as risk factors for developing the events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
51 2021-03-21 deep vein blood clot left calf pain/ significant DVT in left quad; This is a spontaneous report from a contactable consum... Read more
left calf pain/ significant DVT in left quad; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number: EL9264, unknown expiration), via an unspecified route of administration in left arm on 18Feb2021 as single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis and Leiden factor 5. Concomitant medications included etanercept (ENBREL); gabapentin; meloxicam; and vitamin D3. The patient previously took Keflex and experienced allergies. The patient also received first dose of BNT162B2 (Lot number: GL9261, unknown expiration) in left arm on 28Jan2021 at 01:00PM for COVID-19 immunization. On the night of second dose on 18Feb2021 at 08:00 PM (20:00), the patient experienced left calf pain. Then quad pain started 2 weeks later along with the return of calf pain. The patient was diagnosed on 15Mar2021 with a significant DVT in left quad. The patient did not receive other vaccine in four weeks. The patient had no COVID prior to vaccination and not tested for COVID post vaccination. The event significant DVT in left quad resulted in doctor or other healthcare professional office/clinic visit, Life threatening illness (immediate risk of death from the event). The patient is currently on blood thinners as treatment. The patient is recovering from the event. No follow-up attempts are possible. No further information is expected.
51 2021-03-22 chest discomfort, pulmonary embolism Shortness of breath, chest heaviness onset 1 week. 1st vaccine injection 2/17/21, 2nd vaccine 3/17/2... Read more
Shortness of breath, chest heaviness onset 1 week. 1st vaccine injection 2/17/21, 2nd vaccine 3/17/21
51 2021-03-28 chest discomfort autoimmune was exacerbated; shortness of breath; chest tightening; Lose of voice/Loss of voice; Fati... Read more
autoimmune was exacerbated; shortness of breath; chest tightening; Lose of voice/Loss of voice; Fatigue; This is a spontaneous report from a contactable other healthcare professional (HCP, patient). A 51-year-old female received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number= EN6199) injected intramuscularly in left shoulder (left arm) on 09Mar2021 13:30 at age of 51 years old at single dose for COVID-19 immunisation. Medical history included hypertension (HTN), Ehlers-Danlos syndrome (EDS), neurosarcoidosis (diagnosied 1997 with remission since 2002), high cholesterol, depression, gastrooesophageal reflux disease (GERD), osteoarthritis. Allergies to penicillin (no specific manufacturer, lot or expiration) in 1990. Obesity through all her life. No relevant test. Diagnosed allergies, compromised immune status, respiratory illness. There was no family medical history. Patient was not pregnant. There were no additional vaccines administered on same date of the Pfizer Suspect. There were other medications in two weeks. There was not covid prior vaccination. There was no other vaccine in four weeks prior vaccinations. The adverse event patient experienced: lose of voice with shortness of breath with communication and chest tightening, fatigue. This similar to her neurosarcoidosis diagnosied 1997 with remission since 2002. The events started on 10Mar2021 11:30 AM. Received call from consumer regarding the Pfizer COVID vaccine 1st dose. She was losing her voice. She was a pediatric Occupational Therapist. She was eligible on Tuesday for the first dose and went and got it. Her main concern was the symptoms she was having was the same thing that comes out when her autoimmune was exacerbated. She would like to know if it was safe to get next dose. When providing her weight, she said she was not a small girl. There was no prescriber. She was waiting to see if it would disappear before calling Pfizer to report it and it did not. It started yesterday about 24 hours after the vaccine. She received it for prevention and for the population she works with. A lot of her kids she worked with were autoimmune compromised. The majority of her medications she had been on for over two years, so she did not feel they were relevant. No further details provided. No Emergency Room (ER) or physician's office required. She called her physicians' office and they suggested she contact Pfizer. Patient received covid tested post vaccination: nasal Swab/Antigen on 09Feb2021: negative. Outcome of events was not recovered.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of serious events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
51 2021-03-28 blood clot heavy bleeding with lots of blood clots; extended and heavy menstrual period/ heavy bleeding with lo... Read more
heavy bleeding with lots of blood clots; extended and heavy menstrual period/ heavy bleeding with lots of blood clots; This is a spontaneous report from a contactable consumer (patient). A 51-year-old non-pregnant female patient received second dose of BNT162B2 (Pfizer product), lot no. EN5318, via an unspecified route of administration (left arm) on 19Feb2021 at a single dose for COVID-19 immunisation at a workplace clinic. Medical history included high cholesterol and anxiety. No known allergies. No COVID prior to vaccination. Concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (brand: Pfizer, lot no. EL9261, left arm) for COVID-19 immunisation on 30Jan2021 at age of 50 years old. No other vaccine in four weeks. The patient was experiencing extended and heavy menstrual period. Her cycle began on 05Mar2021 and was still happening as of today 16Mar2021. She had heavy bleeding with lots of blood clots. This was not normal for her at all. She is calling her doctor tomorrow. No treatment received for the events. No COVID test post vaccination. The outcome of the events was not recovered.
51 2021-03-30 chest pain blood clot in her lungs; shortness of breath; chest pain; This is a spontaneous report from a non-co... Read more
blood clot in her lungs; shortness of breath; chest pain; This is a spontaneous report from a non-contactable consumer. A 51-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 03Mar2021 as single dose for COVID-19 immunisation. Medical history included obesity and inactivity. The patient's concomitant medications were not reported. On an unspecified date, patient experienced blood clot in her lungs and was hospitalized on 14Mar2021. Patient also experienced shortness of breath and chest pain on an unspecified date. She was treated with anticoagulant therapy for the event "blood clot in her lungs". Outcome of event "blood clot in her lungs" recovered on an unspecified date while for all other events was unknown. No follow-up attempts are Possible. Information on lot/batch cannot be obtained.
51 2021-03-31 deep vein blood clot DVT (deep vein thrombosis) in right medial subclavian; superficial thrombosis in right proximal basi... Read more
DVT (deep vein thrombosis) in right medial subclavian; superficial thrombosis in right proximal basilic vein; right arm swelling in the setting of receiving her Pfizer covid vaccine in the right arm 1 week prior; This is a spontaneous report received from a contactable healthcare professional. A 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in arm right in Mar2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunization. Medical history included hyperlipidemia, acute pancreatitis, May-Thurner syndrome, and allergies: penicillin, IV contrast. Concomitant medications included drospirenone, ethinylestradiol betadex clathrate (YAZ), fenofibrate, and levothyroxine. Patient is not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Patient has not been tested for COVID-19 since the vaccination. Patient was seen at the ED for right arm swelling in the setting of receiving her Pfizer COVID vaccine in the right arm 1 week prior. She was found to have a DVT (deep vein thrombosis) in right medial subclavian and superficial thrombosis in right proximal basilic vein. The events started on 17Mar2021 09:00. AE resulted in emergency room/department or urgent care. Patient was recovering from the events. Treatment for AEs include anticoagulation. Information about lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of subject vaccine cannot be excluded for the DVT and other reported events, based on temporal relationship. However the reported events may likely represent intercurrent medical conditions in this patient. There is very limited information provided in this report. This case will be reassessed upon receipt of follow-up information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
51 2021-04-01 palpitations have been experiencing heart palpitations/flutter on and off for about 6-7 hours; have been experien... Read more
have been experiencing heart palpitations/flutter on and off for about 6-7 hours; have been experiencing heart palpitations/flutter on and off for about 6-7 hours; This is a spontaneous report from a contactable consumer (patient). A 51-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot Number: EL3247), via an unspecified route of administration administered in left arm on 19Feb2021 13:15 at single dose for COVID-19 immunisation. Medical history included migraines from an unknown date and unknown if ongoing. No known allergies. Concomitant medications included clarithromycin (CLARITIN), omeprazole (PRILOSEC), sertraline hydrochloride (ZOLOFT), and statin for cholesterol. The patient previously took the first dose of bnt162b2 (Batch/Lot Number: EL3247), administered in left arm on 27Jan2021 09:15 for COVID-19 immunisation. Patient was not pregnant. Facility type vaccine was clinic. No other vaccine received in four weeks. The patient has been experiencing heart palpitations/flutter on and off for about 6-7 hours on 23Feb2021 04:00. No treatment received. No COVID prior vaccination. No COVID tested post vaccination. Outcome of the events was not recovered.
51 2021-04-07 chest pain Pt received 1st dose of Pfizer vaccine on 3/2/2021. Pt was positive with COVID on 3/22/2021. Pt was ... Read more
Pt received 1st dose of Pfizer vaccine on 3/2/2021. Pt was positive with COVID on 3/22/2021. Pt was admitted to the hospital on 4/7/2021 for chest pain
51 2021-04-10 chest discomfort, chest pain Developed chest pain and pressure which woke patient up from sleep. Clinical history suggestive of p... Read more
Developed chest pain and pressure which woke patient up from sleep. Clinical history suggestive of pericarditis. Patient had previously had COVID-19 in 8/2020. Treated with prednisone and colchicine, pain improving on time of discharge.
51 2021-04-12 fainting sudden severe onset of vertigo; dizziness; syncope; vomiting; This is a spontaneous report from a co... Read more
sudden severe onset of vertigo; dizziness; syncope; vomiting; This is a spontaneous report from a contactable consumer (patient, self-reported). A 51-Year-old female patient (who was not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EN6204 and expiry date was not provided) via an unspecified route of administration, in left arm on 12Mar2021 at 13:30 as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis and immunotherapy. The patient had allergies to penicillin, sulfa drugs and peanuts. The patient's concomitant medications were not reported. The patient previously took ibuprofen and had allergy. The patient stated that On 18Mar2021 at 12:30, the patient experienced sudden severe onset of vertigo and dizziness with syncope and vomiting. The patient was hospitalized for 3 days. On an unknown date in Mar2021, the patient was hospitalized, and a week and a half later still had dizziness which prevents patient from performing daily tasks. Patient received unspecified treatment for the adverse event. Seriousness of the events was reported as hospitalization. Outcome of the events vertigo, syncope, vomiting and loss of personal information was recovering, and for the events dizziness it was not recovered.
51 2021-04-13 fainting, palpitations Systemic: Dizziness / Light headiness-Severe, Systemic: Fainting / Unresponsive-Severe, Additional D... Read more
Systemic: Dizziness / Light headiness-Severe, Systemic: Fainting / Unresponsive-Severe, Additional Details: 6 days after dose patient had a syncopal attack and severe palpitations. Daughter called ambulance after finding mother had fainted.
51 2021-04-17 loss of consciousness passed out; ischemic colitis; This is a spontaneous report received from a contactable consumer (pat... Read more
passed out; ischemic colitis; This is a spontaneous report received from a contactable consumer (patient). This 51-year old female patient (not pregnant) received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number ER8727) at single dose via an unknown route in left arm on 22Mar2021 09:45 for Covid-19 immunization. Prior to vaccination, the patient was diagnosed with COVID-19. Patient had no allergies to medications, food, or other products. Other medications the patient received within 2 weeks of vaccination included fluoxetine hydrochloride (PROZAC), levothyroxine, colecalciferol (VITAMIN D 3), cetirizine hydrochloride (ZYRTEC), and fish oil. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient passed out on Weds evening 24Mar2021 at 09:00 PM, followed by nausea, vomiting, passing of blood, and stomach cramping and was admitted to the hospital on 25Mar2021. Duration of hospitalization was 5 days. Patient was diagnosed with ischemic colitis. This was a condition she had never had before and considered herself completely fine before this incident. A battery of tests uncovered no reason for the passing out to have happened. Lab data included nasal swab on 26Mar2021: negative. The adverse event result in Emergency room/department or urgent care. It was unknown if treatment received for the adverse event. Outcome of the events was resolving.
51 2021-04-20 loss of consciousness, heart rate increased All my muscles and whole body is hurting; All my muscles and whole body is hurting; Chills; Joint pa... Read more
All my muscles and whole body is hurting; All my muscles and whole body is hurting; Chills; Joint pain; I had some wired nausea, I can even hardly eat; I had some wired nausea, I can even hardly eat; My heart rate is kind of low but it's been 125 for last 2 days; I have a rash; I feel dizzy and weak; cannot stand up and walk; I feel dizzy and weak; cannot stand up and walk; I feel dizzy and weak; cannot stand up and walk; My lymph nodes are very swollen; I have ray nods also that's circulation disorder; I feel like I have been freezing cold ever since I got the second shot; I got half fever; I have ray nods also that's circulation disorder; I feel like I have been freezing cold ever since I got the second shot; I got half fever; I have been passed out; I had mine my fever gone up to 104.9 and down to 103; my arm is swollen, hard and hurts terribly; my arm is swollen, hard and hurts terribly; whole arm get deep red; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, in the left arm on 01Apr2021 (Batch/Lot Number: EN6199) (at the age of 51 years old) at a single dose for covid-19 immunisation. Medical history included lupus and high blood pressure both from an unknown date. Concomitant medications included sertraline hydrochloride (ZOLOFT), clonazepam (KLONOPIN) and topiramate (TOPAMAX) all taken for an unspecified indication, start and stop date were not reported. The patient previously took the first dose of BNT162B2 on 12Mar2021 (lot number: EN6198) (at the age of 51 years old) and reported that she was really not feeling well. On 01Apr2021, the patient got the second dose of covid vaccination and reported that she had a pretty serious side effect since the first one. The patient then reported her fever gone up to 104.9 and down to 103 and reported that she was worried about herself, not only the fever; her arm is swollen, hard and hurts terribly; patient reported that all her muscles and whole body is hurting and the chills, the joint pain of course the fever and further reported that had some wired nausea, she can even hardly eat. The patient then stated that within a few hours after her shot, she started having mild problems: swelling of her arm, her whole arm get deep red and throughout pain in her arm. The patient had a video call with her primary care doctor, the doctor said it's just normal, don't worry about it, the doctor didn't let the patient give all her symptoms (as reported). The patient further stated she have that pain and something is not right in her body and that she have been taking Tylenol. The patient also reported that her heart rate is kind of low but it's been 125 for last 2 days (as reported), patient reported that she has a rash, feel dizzy and weak, cannot stand up and walk, the patient have attended to go for her family house for the Easter and she was there for 15 minutes. Keep in mind Covid normally they all were vaccinated and it's been a very special time, but within 15 minutes the patient have been passed out and had been taking home and further reported that her lymph nodes are very swollen and her head is killing her. The patient have an electric blanket in her arm because she have chills so bad, her joints are hurting and she have ray nods (as reported) also that's circulation disorder and she feel like she have been freezing cold ever since she got the second shot. The outcome of the events was unknown.
51 2021-04-24 hypertension A spike in her BP; This is a spontaneous report from a contactable pharmacist. A 52-year-old female ... Read more
A spike in her BP; This is a spontaneous report from a contactable pharmacist. A 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection) intramuscularly in the left arm on 11Mar2021 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension from an unspecified date and unspecified if ongoing (not taking meds for this prior to this event) and strawberries - anaphylaxis from an unspecified date and unspecified if ongoing. It was unknown whether the patient was diagnosed with COVID-19 prior to vaccination. It was unknown if the patient was pregnant. Concomitant medications ("other medications in two weeks") included acetaminophen taken for an unspecified indication from an unspecified date and unspecified if ongoing, as needed. It was unknown whether the patient received any other vaccine within four weeks of the COVID-19 vaccine. The patient experienced a spike in her BP (blood pressure) on an unspecified date ("with her first dose"). The clinical outcome of the event a spike in her BP was unknown. Since the vaccine, it was unknown whether the patient was tested for COVID-19. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect vaccine BNT162B2 in triggering the onset of "a spike in her BP" cannot be excluded. The event was confounded by underlying hypertension. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
52 2020-12-31 heart rate increased, chest discomfort Flushing, sweating, increased heart rate proceeded to feel difficulty swallowing and clearing my thr... Read more
Flushing, sweating, increased heart rate proceeded to feel difficulty swallowing and clearing my throat. I was taken to the ER. The symptoms progressed to feeling dizziness, difficulty speaking, and chest pressure with increased SBP/DBP. General nausea and feeling very unwell.
52 2021-01-01 heart rate increased 12/29/2020 (date of injection) soreness at injection site, Headache & increased Heart Rate. 12/30/2... Read more
12/29/2020 (date of injection) soreness at injection site, Headache & increased Heart Rate. 12/30/2020 Headache, Chills, Body Aches, Fatigue. 12/31/2020 Headache, increased Chills, increased Body Aches, increased Fatigue, feeling Feverish (not able to do ADL's). 1/1/2021 Headache, increased Chills, increased Body Aches, increased Fatigue, feeling Feverish (not able to do ADL's). 1/2/2021 All symptoms are getting better, still slightly there.
52 2021-01-02 chest pain Pfizer-BioNTech COVID-19 Vaccine EUA Slight chest pain and slight difficulty taking deep breath for ... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Slight chest pain and slight difficulty taking deep breath for a few seconds it - did not go past 15 minute observation. Felt nauseated for a brief time - did not go past the 15 minutes. About 25 minutes after the tip of my tongue, section of my bottom lip and sides of my tongue were tingly. The tip of my tongue continues to be like that day #2 after and there is a small blood blister underneath the tip of my tongue. Parts of my body feel a little itchy an hour after vaccine and continues very infrequently at this time and it disappears in seconds.
52 2021-01-04 heart rate increased APPROXIMATELY 8 -10 MINUTES AFTER THE VACCINE MY HEART RATE INCREASED, KIND OF SUDDENLY - SHORLY AFT... Read more
APPROXIMATELY 8 -10 MINUTES AFTER THE VACCINE MY HEART RATE INCREASED, KIND OF SUDDENLY - SHORLY AFTER THAT I FELT A 'RUSH' FROM HEAD TO TOE. ALL OF THIS HAPPENED OVER MAYBE 20 SECONDS - THEN MY HR DECREASED TO NORMAL AND I FELT FINE.
52 2021-01-04 palpitations, chest pain Approximately 10 minutes after vaccine administration, patient developed chest pain, skin cool and c... Read more
Approximately 10 minutes after vaccine administration, patient developed chest pain, skin cool and clammy. Felt like heart racing. Dizzy. Radial pulse 88 and regular. BP 116/72. Patient declined going to the Emergency Department and was observed for approximately another 30 min, Chest discomfort subsided. Her husband ( an MD) came in and took her to his office for further observation.
52 2021-01-04 chest discomfort Chest tightness and minimally SOB; weakness, chills generalized feeling of being yucky; did see prov... Read more
Chest tightness and minimally SOB; weakness, chills generalized feeling of being yucky; did see provider and CXR and EKG normal. States low-grade fever lasted couple of days.
52 2021-01-04 palpitations Palpitation; flashed face; warm feeling under the sternum; rush to both lower extremities to the toe... Read more
Palpitation; flashed face; warm feeling under the sternum; rush to both lower extremities to the toes as if I was given IV contrast Dye; Thirst; Hunger; This is a spontaneous report from a contactable nurse (patient). This 52-year-old female nurse reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EJ1685), via intramuscular at left arm on 17Dec2020 04:30 PM at single dose for COVID-19 immunization. The facility type of vaccine was hospital. Medical history included diabetes, HTN, vertigo, sleep apnea, colonic diverticulitis, fibroid uterus, left cystic breast; pulmonary valve prolapse. No known allergies. No COVID prior vaccination. No COVID tested post vaccination. Concomitant medication included atorvastatin; metformin; eplerenone; HCTZ; levonorgestrel (MIRENA); ascorbic acid, biotin, calcium carbonate, calcium pantothenate, cyanocobalamin, nicotinamide, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride (BEROCCA) for supplement; montelukast sodium (SINGULAIR); loratadine (CLARITIN). No other vaccine in four weeks. On 17Dec2020, patient experienced palpitation; flashed face; warm feeling under the sternum; rush to both lower extremities to the toes as if being given IV contrast dye; thirst; hunger. No treatment for events. It was reported as non-serious. Outcome of events was recovered.
52 2021-01-04 chest pain, blood pressure increased Patient described leg heaviness the following day (12/18/20), then onset on 12/19/20 of blisters to ... Read more
Patient described leg heaviness the following day (12/18/20), then onset on 12/19/20 of blisters to neck, chest and abdomen, chest pain, and elevated blood pressure. Patient states she is already on cardiac medications so she took an additional dose for her blood pressure and monitored herself closely.
52 2021-01-04 chest discomfort chest tightness; 103.8; Fatigue; body aches; headache; nausea; This is a spontaneous report from a c... Read more
chest tightness; 103.8; Fatigue; body aches; headache; nausea; This is a spontaneous report from a contactable other healthcare professional (HCP). This 52-year-old female HCP reported for herself that she received 1st dose of BNT162B2 intramuscular at left arm on 28Dec2020 08:30 AM for Covid-19 immunization. Medical history included COVID-19 and concomitant drugs were not provided. The patient did not realize vaccine should be taken 90 days after a covid infection tested positive on 12Jan2020. The patient received vaccine on 28Dec2020, she experienced 103.8, fatigue, body aches, headache, nausea, and some chest tightness on 29Dec2020 at 09:00 AM. No treatment was received. The outcome of the events was resolving. The events were reported non-serious. Information about lot/batch number has been requested.
52 2021-01-05 chest discomfort, palpitations Felt dizzy Racing heart with chest pressure Some difficulty breathing Clammy palms Placed me in ... Read more
Felt dizzy Racing heart with chest pressure Some difficulty breathing Clammy palms Placed me in supine position Observation maintained until vitals returned to normal
52 2021-01-05 chest discomfort Headache, chill, body aches, fever, malaise, runny nose, sore throat, loss of taste, night sweats, n... Read more
Headache, chill, body aches, fever, malaise, runny nose, sore throat, loss of taste, night sweats, nausea, diarrhea, chest tightness, dry cough
52 2021-01-05 blood pressure decreased, heart rate increased Immediate after injection- tingling, numbness, dizziness, confusion, vision disturbance (dilated p... Read more
Immediate after injection- tingling, numbness, dizziness, confusion, vision disturbance (dilated pupils), loss of BP, rapid heart rate, uncontrollable rigors/trembling. Rushed down hall to ED via stretcher. Received IV fluids, IV steroids, IV benedryl, IV pepcid, IV ativan.
52 2021-01-05 palpitations, pallor PARKING LOT ATTENDANT CAME RUNNING INTO CLINIC STATING CLIENT WAS COMPLAINING OF DIZZINESS, HEART PA... Read more
PARKING LOT ATTENDANT CAME RUNNING INTO CLINIC STATING CLIENT WAS COMPLAINING OF DIZZINESS, HEART PALPATIONS, AND APPEARED PALE. CLIENT STATED HISTORY OF LOW BLOOD PRESSURE. BLOOD PRESSURE TAKEN ABOUT 1420. 120/90. EMT NOTIFIED THAT THEY MAYBE NEEDED. EPINEPHRINE BROUGHT TO CAR. ENCOURAGED CLIENT TO TAKE SLOW, DEEP BREATHS. AFTER 10 MINUTES, STATED FELT MUCH BETTER. PARKING ATTENDANT STATED CLIENT'S COLOR HAD RETURNED. ENCOURAGED TO WAIT FOR ANOTHER 10 MINUTES BEFORE DRIVING AWAY.
52 2021-01-05 heart rate increased RAPID HEART RATE 150-160, SHAKY FEELING 10 MIN POST VACINATION
52 2021-01-06 heart rate irregular, chest pain, palpitations 12/22 vaccination. Felt fine. Arm sore 12 hours 12/26 - sudden sharp pain in chest, palpitations. H... Read more
12/22 vaccination. Felt fine. Arm sore 12 hours 12/26 - sudden sharp pain in chest, palpitations. HR irregular. waiting 15 min. Went to the ER. Frequent PVCs; occasionally over the years. Discharged home. Not sure if related to vaccine as under a lot of stress.
52 2021-01-06 blood pressure decreased Dizziness, HYPOtension, blurred vision Narrative: Reaction at 30 min- Dizziness, blurred vision, B... Read more
Dizziness, HYPOtension, blurred vision Narrative: Reaction at 30 min- Dizziness, blurred vision, B/P dropped to 95/55- She stayed in ER until 11am, No Sxs of breathing issues or SOB. She was NOT admitted, just observed until B/P went up. Vaccine was given in the ED- reason not given.
52 2021-01-07 palpitations General Malaise, Light Headed, Palpitations & Nausea
52 2021-01-07 fainting HEADACHE, NAUSEA, VOMITING, SYNCOPE, JOINT PAIN, WEAKNESS, EXTREME FATIGUE. STARTED ON 1-1-21, NAUSE... Read more
HEADACHE, NAUSEA, VOMITING, SYNCOPE, JOINT PAIN, WEAKNESS, EXTREME FATIGUE. STARTED ON 1-1-21, NAUSEA AND VOMITING STOPPED ON 1-2-21 BUT RETURNED ON 1-8-21.
52 2021-01-07 blood pressure increased, lightheadedness, palpitations Patient felt warm with palpitations 5 minutes after vaccine administered. was monitored for 30 mins ... Read more
Patient felt warm with palpitations 5 minutes after vaccine administered. was monitored for 30 mins & then returned to work. on 12/30/2020 patient was at work in Presurgical testing dept & experienced near syncope, dizziness & elevated BP. reported to ED & was admitted to telemetry unit.
52 2021-01-08 hypertension, blood pressure increased HYPERtension throat tightness, paresthesias in extremities, muscle spasms Narrative: Shortly after r... Read more
HYPERtension throat tightness, paresthesias in extremities, muscle spasms Narrative: Shortly after receiving the vaccine she felt uneasy and experienced the sensation of throat tightness and numbness and tingling in hands and feet, also some rigidity/clonus in the hands. No rash, no wheezing, O2 sat 99%+. The team at the vaccination clinic checked her vital signs and her systolic BP was elevated to 220's. A rapid response was called and she was taken to the emergency room. In the emergency room, she received a neurology consult and head CT to rule out hypertensive bleeding. The scan was negative. She was given labetalol 10mg IV to lower BP, and also solumedrol 125mg, benadryl 25mg. No epinephrine given. Serum potassium was found to be low as well; given oral potassium repletion. Discharged from ER by noon same day, BP down to 160/79.
52 2021-01-08 hypertension Tongue became swollen and itchy, throat was scratchy and felt constricted. High blood pressure was h... Read more
Tongue became swollen and itchy, throat was scratchy and felt constricted. High blood pressure was high, dizziness and ringing in the ears
52 2021-01-08 chest pain after receiving vaccine patient immediately felt warm, dizzy and started dry heaving. we dosed Zofra... Read more
after receiving vaccine patient immediately felt warm, dizzy and started dry heaving. we dosed Zofran 4mg, gave one dose epi-pen, and 50mg Benadryl. patient still complained of chest pain and was dry heaving. she was then transported by ems to the hospital at 4pm.
52 2021-01-09 blood pressure increased Turned red in upper torso, swelling to tongue and heightened blood pressure.
52 2021-01-10 fast heart rate 30 minutes after vaccine, developed dizziness. This progressed and also developed tachycardia and h... Read more
30 minutes after vaccine, developed dizziness. This progressed and also developed tachycardia and headache, worsening over next 15 minutes, with skipped beats. Heart rate was 115 and decreased 93 with breathing exercises for relaxation. Blood pressure was steady at about 190/110 ( she states she stopped her blood pressure medication 3 days prior). she was taken to ED for further evaluation and treatment
52 2021-01-10 chest discomfort, chest pain Symptoms started 1/4/21 @ 1800 with dry heaving, body aches, fever, then started coughing and shortn... Read more
Symptoms started 1/4/21 @ 1800 with dry heaving, body aches, fever, then started coughing and shortness of breath that night. Next day still had fever, severe body aches and cough got worse with shortness of breath. I did home nebulizer several times and started prednisone 40mg. 1/6/21 shortness of breath worsened to the point I couldn't talk, chest tightness with burning. Went into ED at hospital where they gave me another breathing treatment x 2, magnesium sulfate, IV solu medrol. They were going to admit me but I decided against it with all the covid patients.
52 2021-01-10 chest pain, fast heart rate tachycardia that is still ongoing with some chest pains
52 2021-01-11 chest pain Chest Pain 2 weeks after receiving vaccine
52 2021-01-11 chest discomfort Lips and tongue became numb, throat felt itchy, severe nausea, headache, chest tightness, rash - fir... Read more
Lips and tongue became numb, throat felt itchy, severe nausea, headache, chest tightness, rash - first neck and face then rash progressed to a diffuse rash over entire body. I was on my way home and drove to Er and was seen. I was given Zolfran, Pepcid Solumedrol, Benadryl and Epinephrin.
52 2021-01-12 fast heart rate, chest discomfort, hypertension After about 20 minutes, the patient stated she felt short of breath, chest tightness, and her face b... Read more
After about 20 minutes, the patient stated she felt short of breath, chest tightness, and her face became red. The nurses took her vitals which showed hypertension and tachycardia. She was lowered to the ground and given some juice while a code was called. When the code team arrived, the patient was alert and oriented within the vaccination clinic, she was then transferred to the ER by nursing staff and hospital security.
52 2021-01-12 chest pain Chest pain; This is a spontaneous report from a contactable pharmacist. A 52-year-old female patient... Read more
Chest pain; This is a spontaneous report from a contactable pharmacist. A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL1284/expiration date unknown), dose number 1 intramuscularly on 07Jan2021 11:00 at a single dose on the right arm for COVID-19 immunization. The patient had no relevant medical history. There were no concomitant medications. The patient received the vaccine at a nursing home/senior living facility. No medications were received within 2 weeks of vaccination and no other vaccines were received within 4 weeks prior vaccination. The patient experienced chest pain on 07Jan2021 12:00. The went to the emergency room/sought urgent care for the event. No treatment was received for the event. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination. The outcome of the event was unknown. The event was assessed as non-serious. No follow-up attempts are possible. No further information is expected.
52 2021-01-12 palpitations dizziness with perceived palpitations; facial flushing and headache
52 2021-01-13 chest pain About 10 to 12 minutes after the injection, I started feeling like my throat was constricted. I fel... Read more
About 10 to 12 minutes after the injection, I started feeling like my throat was constricted. I felt pain in my temple and I also felt like my ears were clogged. My tonugue was tingling and I had pain across my chest. I had trouble swallowing and taking a deep breath. The medical providers assessed me and since my heart was not racing and I did not have a rash all over my body, deemed I was okay. When I went home, I noticed a rash on my chest from my collarbone to my sternum and alongside my ears on my neck. My sister is an ER Doctor and I did a video conference with her. She had me take Benadryl. I have never had any reaction to any vaccine nor have I ever had to take Benadryl.
52 2021-01-13 chest discomfort During post vaccine monitoring after patient received initial COVID vaccine patient reported feeling... Read more
During post vaccine monitoring after patient received initial COVID vaccine patient reported feeling tightness in her chest and feeling harder to breath. Pt reports that this has occurred in the past with other allergic reactions. VS assessed 136/74, HR 105, SPO2 97. Pt transferred to ER for continued monitoring. Patient given dexamethasone, diphenhydramine, famotidine, ipratropium, and ondansetron
52 2021-01-13 palpitations IM given@ 9;00am and at 9;08 am pt. begin to c/o palpitaions. VS taken R 22 P70 BP 154/112 sats ... Read more
IM given@ 9;00am and at 9;08 am pt. begin to c/o palpitaions. VS taken R 22 P70 BP 154/112 sats 99% pt. states has Hx . HTN and she says took her BP medication this morning. VS re-check at 9:15 am BP 153/102 HR 66 Sat 99% R20. Pt states feels better now , denies any more symptoms.
52 2021-01-13 fast heart rate Individual initially felt fine after receiving the vaccine with just sore arm. 24-hours later on 12/... Read more
Individual initially felt fine after receiving the vaccine with just sore arm. 24-hours later on 12/29 around noon she started feeling tachycardic (resting heart rate was 107-125 bpm). She vomited and felt anxious. Developed fever of 101.8 and was very achy. Day 2: low grade fever treated with ibuprofen. Day 3: fever free but dizzy feeling. Day 4: symptoms resolved. Of note, patient was 30 days out from having had COVID-19 at the time of vaccination. Patient states her course of COVID was "serious" but did not require hospitalization.
52 2021-01-13 chest pain Nausea, headache, body aches and pains, fever of 100.7 orally and chills, chest pain, feeling of bu... Read more
Nausea, headache, body aches and pains, fever of 100.7 orally and chills, chest pain, feeling of burning at surgical scar site, malaise starting around 18 hours post injection and lasting about 14 hours. Minimal to zero relief with Ibuprophen, or Acetaminophen. No medical treatment required. Headache continues to persist but chronic headaches are part of normal history.
52 2021-01-13 fainting Systemic: Anaphylaxis-Severe, Systemic: Nausea-Medium, Systemic: Fainting-Medium
52 2021-01-14 hypotension Before receiving vaccine, patient was visibly anxious and fearful of the shot. Within 5 minutes of ... Read more
Before receiving vaccine, patient was visibly anxious and fearful of the shot. Within 5 minutes of receiving vaccine, patient complained of lightheadedness. Vital signs showed slight hypotension which improved with hydration.
52 2021-01-14 blood pressure decreased onset same day of vaccine, c/o chills, no fever, pain in hips and legs and low BP 80/52
52 2021-01-15 chest discomfort, chest pain 11:40 am - receives the 1 dose of the Pfizer Covid vaccine 0.3mg IM 11:50 am - reports the symptoms ... Read more
11:40 am - receives the 1 dose of the Pfizer Covid vaccine 0.3mg IM 11:50 am - reports the symptoms of tingling, warmness, pressure, burning on her upper left chest. Nausea and dizziness 11:58 am - takes diphenhydramine 50mg, (2 capsules of 25mg) by mouth 12:02 pm - receives 1 dose of EpiPen autoinjector 0.3mg IM. 911 call 12:05 pm - reports feelings of tightening in her throat and receives 2nd dose of EpiPen autoinjector 0.3mg IM 12:10 pm - reports that tightening in her throat is relieving 12:15 pm - EMS arrives and is transporting her to the ER
52 2021-01-17 blood pressure decreased Pt. C/O flushing, sweating and feeling feverish, an exaggeration of her reaction to the first vaccin... Read more
Pt. C/O flushing, sweating and feeling feverish, an exaggeration of her reaction to the first vaccine. She denied pain, difficulty breathing or other complaints. She lay down, got a cold compress and felt significantly better
52 2021-01-18 heart rate increased, pallor After having the vaccination, felt woozy, headache. Went to bed, up Sunday morning, about 1:30, 1:45... Read more
After having the vaccination, felt woozy, headache. Went to bed, up Sunday morning, about 1:30, 1:45 had sever headache, feverish, no energy, sick to her stomach. Monday morning, excessive heart rate. Did not go to work. Was pale looking. By Monday evening, felt better. Today, wasn't feeling 100% but did go back to work.
52 2021-01-18 blood pressure increased Lethargy, Dizziness, Shivering , increased BP
52 2021-01-19 fast heart rate, hypertension Approximately 15 minutes after receiving second vaccine dose, patient reported feeling light-headed ... Read more
Approximately 15 minutes after receiving second vaccine dose, patient reported feeling light-headed and a subjective swelling of her left cheek. Patient was tachycardic and hypertensive; taken to ER for observation. Received a dose of oral diphenhydramine 50 mg. Was ultimately discharged home in stable condition.
52 2021-01-19 palpitations Heart Racing, Heat rush
52 2021-01-19 heart rate increased RASH, SWELLING LEGS AND SEVERE PAIN INABILITY TO GO UP STAIRS, BREAKOUT IN MOUTH ,FAST HEARTBEAT, FE... Read more
RASH, SWELLING LEGS AND SEVERE PAIN INABILITY TO GO UP STAIRS, BREAKOUT IN MOUTH ,FAST HEARTBEAT, FEVER
52 2021-01-20 heart attack, heart attack, troponin increased, chest pain Heart attack / she had a MI / diagnosed as a NSTEMI; This is a spontaneous report from a contactable... Read more
Heart attack / she had a MI / diagnosed as a NSTEMI; This is a spontaneous report from a contactable healthcare professional (patient). This 52-year-old female patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in left arm, on 07Jan2021, for COVID-19 vaccination. Medical history included autoimmune thyroiditis (Hashimoto's thyroiditis) from 1998 and vitiligo from 1988. She was overweight. She had really no other risk factors. Concomitant medications were not reported. On 08Jan2021 the patient experienced heart attack and she had a MI, then a cardiac catherization that was normal and a normal echo as well. She said it was diagnosed as a NSTEMI and not a large MI, the smaller version. These events required hospitalization from 08Jan2021 to 12Jan2021. MI occurred after she finished clinic and she was not standing or doing anything, just sitting and she had chest pain. Her office was right next to the ER, so she received treatment within an hour and they were able to help her. She said that her hospital couldn't do a cardiac cath, so on 11Jan2021 they moved her to an hospital which was another treatment facility. When she had her MI they gave her acetylsalicylic acid (ASPIRIN) and sublingual nitroglycerin. They tested her troponin and did an EKG which was abnormal on an unspecified date in Jan2021. On 08Jan2021 troponin was increased. When they treated her with nitroglycerin and Aspirin, two hours later her EKG was normal and her troponin came down overnight on 09Jan2021, which was when they said for sure that she had a heart attack. The patient said it was very scary to have a heart attack, but thankfully there was not a lot of damage done and she was able to get treatment quickly. She did not think the event was disabling since they did not see much damage to her heart muscle, it was a near miss kind of thing. She said it was life changing in that she will now be on medication forever, she will be on at least a baby Aspirin and probably something like a statin for the rest of her life. She was recovering, it was unknown what the lasting effects may be, she felt normal but tired from her hospital stay. Heart attack resolved on 08Jan2021. Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event acute myocardial infarction cannot be excluded. The contributory role of the patient age and background of obesity cannot be excluded as well. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
52 2021-01-20 palpitations Mild feeling of throat constricting; dizziness; palpitations; Left arm sore; Circular rash next to i... Read more
Mild feeling of throat constricting; dizziness; palpitations; Left arm sore; Circular rash next to injection site; This is a spontaneous report from a contactable other hcp (patient). A 52-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ELO140), via an unspecified route of administration in left arm on 06Jan2021 14:30 at single dose for COVID-19 immunization. Medical history included high blood pressure and brachial radial puritis. Concomitant medication included metoprolol succinate (TOPROL) and estrogens conjugated (PREMARIN). No COVID prior vaccination. No other vaccine in four weeks. The patient experienced mild feeling of throat constricting, dizziness, and palpitations, left arm sore, Circular rash next to injection site on 06Jan2021 14:45 (for about 20 minutes), left arm sore for about 4 days. No treatment received. No COVID tested post vaccination. The outcome of events was recovered in Jan2021.
52 2021-01-20 heart rate increased Received vaccination #2 1/18/21 at 1000am. Dr. appointment at 1pm. EKG no known abnormalities. 1530 ... Read more
Received vaccination #2 1/18/21 at 1000am. Dr. appointment at 1pm. EKG no known abnormalities. 1530 feet achy R arm where got shot - had muscle spasms in back, Body aches, heart rate 110. 1/19/21-worked 1/19/21 no muscle spasms.
52 2021-01-20 palpitations The episode came on very quickly. Felt like I was going to pass out. Became very flushed, heart wa... Read more
The episode came on very quickly. Felt like I was going to pass out. Became very flushed, heart was racing and very shaky. I work at a clinic, so my blood pressure was taken and it was 160/100, pulse was 120. Had a bad head ache and continued to have waves of this for about an hour.
52 2021-01-21 palpitations Palpitations, Racing Heart
52 2021-01-21 excessive bleeding Vaccine was administered around 4-pm into right arm and bleeding occurred after administration. Aro... Read more
Vaccine was administered around 4-pm into right arm and bleeding occurred after administration. Around 3 am, I awoke with chills and low grade fever. Tmax 103.8F, chills, pressure headache, neck/back pain, and fatigue that lasted ~30 hours. Still have mild pressure headache with mild back/neck pain and weakness.
52 2021-01-22 chest discomfort The night before I felt a heaviness in my chest, trouble breathing and the next morning I felt the s... Read more
The night before I felt a heaviness in my chest, trouble breathing and the next morning I felt the same. I called my PCP and had a EKG and Covid swab (negative). She prescribed me steroids'.
52 2021-01-23 fast heart rate, chest discomfort After receiving 2nd dose of Pfizer vaccine, within 5 minutes, c/o chest pressure, tachycardia (P=105... Read more
After receiving 2nd dose of Pfizer vaccine, within 5 minutes, c/o chest pressure, tachycardia (P=105) and left arm pain. team was called and was taken to the ER.
52 2021-01-24 blood pressure increased fever/102.3 temperature; headache; achy all over; Within 3 minutes had tingling pins in mouth tongue... Read more
fever/102.3 temperature; headache; achy all over; Within 3 minutes had tingling pins in mouth tongue and throat; Within 3 minutes had tingling pins in mouth tongue and throat; had hard time breathing; O2 sat were at 91; i had High BP 148/92; severe fatigue; This is a spontaneous report from a contactable Other HCP (patient). This 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number=EJ1686), via an unspecified route of administration on 05Jan2021 07:00 at single dose on the left arm for COVID-19 immunization. Medical history included attention deficit hyperactivity disorder (ADHD), asthma, depression, irritable bowel syndrome (IBS), known allergies included bacitracin, penicillin, levofloxacin (LEVAQUIN), metronidazole (FLAGYL), oseltamivir phosphate (TAMIFLU), Bees, Hornets. Patient took other medications in two weeks. No other vaccine received in four weeks. Patient was not pregnant. Facility type vaccine was hospital. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. On 05Jan2021 07:03, within 3 minutes patient had tingling pins in mouth tongue and throat, had hard time breathing. The nurses gave her 50 mg of diphenhydramine hydrochloride (BENADRYL). The doctors checked her O2 sat were at 91, and she had High BP 148/92. After 40 minutes (05Jan2021 07:43) after the medication her symptoms seem to go away and she could breath better. She went home and went to bed because she work night shift. She got the vaccine when she got off work, then about six hours later (05Jan2021 13:00) she had bad headache and achy all over, 12 hours later (05Jan2021 19:00) she had 102.3 temperature and took paracetamol (TYLENOL) every 4 hours and fever finally broke 26 hours later (06Jan2021 21:00). She continued to have a headache for about 5 days and severe fatigue. Adverse event resulted in life threatening illness (immediate risk of death from the event). Patient was recovered with lasting effects.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported life threatening events including tingling pins in mouth tongue and throat, had hard time breathing, PO2 decreased, blood pressure increased, bad headache, achy all over, fever, and severe fatigue, and the administration of the COVID 19 vaccine, BNT162B2, considering the plausible temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
52 2021-01-26 chest discomfort 11:15 reported chest tightness - used her inhaler b/p 12/80 heart rate 86. reported slightly light h... Read more
11:15 reported chest tightness - used her inhaler b/p 12/80 heart rate 86. reported slightly light headed had two masks on placed in private room so she could remove masks. 11:21 breathing better masks removed 11:35 b/p 130/90 heart rate 94 breathing easy. Informed to only wear one mask. Instructed to Call 911 for further breathing difficulty.
52 2021-01-26 heart rate irregular, chest pain Pfizer-BioNTech COVID-19 Vaccine EUA: Shortly after receiving the vaccine patient stated they had ch... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA: Shortly after receiving the vaccine patient stated they had chest pain, shortness of breath, nausea, back pain, and sweating. On evaluation a mild systolic murmur and irregular heartbeat were noted. Patient was transferred to the emergency department where initial vitals were within normal ranges except for blood pressure 145/104 mmHg. No wheezing, vomiting, respiratory distress, or anaphylaxis noted. Patient administered aspirin, morphine, acetaminophen, diphenhydramine, ibuprofen, and ondansetron and symptoms resolved. Repeat vitals were within normal ranges and patient discharged to home stable.
52 2021-01-26 chest pain, chest discomfort Reports usual chest pressure related to lupus condition but after getting Covid vaccine it is now a ... Read more
Reports usual chest pressure related to lupus condition but after getting Covid vaccine it is now a sharp pain, reports dizziness 6/10 and "different". Increased pain with deep breaths. denies nausea. Taken to ED with RR
52 2021-01-26 atrial fibrillation The day after my vaccine went into A-fib and had to go home then on Saturday 01-23-2021 the A-fib wa... Read more
The day after my vaccine went into A-fib and had to go home then on Saturday 01-23-2021 the A-fib was gone
52 2021-01-27 palpitations, chest pain By that evening my right arm went numb and I had a lot dizziness and brain frog. I was slow to stop ... Read more
By that evening my right arm went numb and I had a lot dizziness and brain frog. I was slow to stop at stop sign, and my daughter in law told me she wanted to drive me because I was scaring her and I was being mean to her, very snappy. The next morning I had a fever 100, muscle ache, heart racing, headache and I stayed in bed all day. I took 2000mg Ibuprofen, 800mg Tylenol, Benadryl 10mg. On the 20th I was still lethargic had body aches and heart was racing, I took 800mg Tylenol that day. The 21st I had dizziness, brain fog, heart racing, lethargic. The 22nd I contacted the work Nurse and let her know what was going on, my heart rate was 140. They told me I was probably having a reaction and would go away in a couple days. On the 24th,25th,26th,27th I started having chest pain, lethargy. I had a clinic visit with my PCP on the 28th and she said my BP was 160/90, I never had BP issues. She ran test. The 29th I still had brain frog, lethargy, chest pain. I could feel my heart beat in my ear especially at night, I have never has BP issues in my life. On the 30th my heart ponding sound was in my ear. January 16th I went to the ER my heart was 130 and BP 187/108, they did a full work up on me. She started me on Metprolol-50mg(extended release). I seen the cardiologist on 1/20 and told me I had left atrial enlargement , mitro-valve regurgitation . I had an echo- cardiogram on 1/25. The medicine has definitely helped me .
52 2021-01-27 blood pressure increased slightly light headed; rt hand got red & hot; rt hand got red & hot; numb, heat in rt arm/right sid... Read more
slightly light headed; rt hand got red & hot; rt hand got red & hot; numb, heat in rt arm/right side of jaw felt numb; Blood pressure went up to something over 90; fatigued; it hurt to open my mouth (gland by rt ear felt swollen); got a line of inflammation in my rt inside cheek; This is a spontaneous report from a contactable other HCP (patient). A 52-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number= EL0140), intramuscular at right arm on 23Dec2020 16:45 at single dose for covid-19 immunization. The patient medical history was not reported. Concomitant medication in two weeks included Multi vitamin, tocopherol (VITAMIN E), vitamin d3, bioidenticle estrogen/progesterone. The patient previously took Iodine, metronidazole (FLAGYL), Doxycycline, clarithromycin (KETEK); and known allergies to them. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient felt slightly light headed. Within 5 minutes right hand got red & hot, numb, heat in right arm & right side of jaw felt numb as if blew up balloons. Blood pressure went up to something over 90. The patient took a benadryl. Next few days v fatigued & on p.m. of 24th it hurt to open her mouth (gland by right ear felt swollen). The patient got a line of inflammation in her right inside cheek & a tissue mound that had not gone away. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was recovering.
52 2021-01-28 fast heart rate, hypertension Tightness in throat, hypertensive, tachycardia, hives on face and upper chest, vomitting
52 2021-01-29 blood pressure increased Within 10 minutes, sensation of very cold skin through out my body, lasted 4 hours. Transient elevat... Read more
Within 10 minutes, sensation of very cold skin through out my body, lasted 4 hours. Transient elevated systolic BP, better within 30 mins. Also mild body itching, still having. Woke up this morning, ~24 hours post- injection with sever joint and muscle aches, chills etc. had to cancel work.
52 2021-01-31 fast heart rate Elevated BP, tachycardia, nausea, vomiting, diarrhea, headache, fatigue
52 2021-01-31 fast heart rate Pt states first s/s at 1500 she started to feel body aches, HA, dizzy, nausea, loss of appetite chil... Read more
Pt states first s/s at 1500 she started to feel body aches, HA, dizzy, nausea, loss of appetite chills and fever of 100.7 with episodes of sweating profusely. 1/19/21 Pt states fever continues, body aches, (L) axillary lymph node swelling, HA, Nausea and a episode of Tachycardia that she recorded temp. ranged 101-102.2. 1/21/20 Pt stated to have cont. fever 102.2, HA, BA, sweating and lymph nodes swelling from (L) axillary to back painful. Pt States on 1/21/21 cont. sweating loss of appetite, nausea, weakness, fatigue injection site pain, no redness, warm, and palpable lump. Pt stated 1/23/21 body aches and fever. Pt resting drinking fluids as tolerated and taking advil 400 mg PRN 4mg Zofran
52 2021-01-31 hypertension, palpitations Rapid HR with ringing in ears, dizzy, high blood pressure, approx., 10 minutes after injection. Sym... Read more
Rapid HR with ringing in ears, dizzy, high blood pressure, approx., 10 minutes after injection. Symptoms went away without intervention at 30 minutes post injection. Became short of breath with elevated heart rate and blood pressure again approx. 45 min. post injection tat worsened when standing, walking or talking, HR 143 BP 229/127 I was sent to the ED to monitor had a EKG, Benadryl, Pepcid, Then I had sinus tachycardia in ED, stayed until approx. 4 hours past injection. Symptoms resolved at time of DC
52 2021-02-01 loss of consciousness passed out; hit chin on the sink; vomited; Fever; chills; This is a spontaneous report from a non-co... Read more
passed out; hit chin on the sink; vomited; Fever; chills; This is a spontaneous report from a non-contactable consumer (patient). A 52-year-old female patient (non-pregnant) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Jan2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient previously received first dose of bnt162b2 at single dose on unspecified date for covid-19 immunization. Patient had one of the worst nights, fever/chills on 18Jan2021. Got up at 1:30 on 19Jan2021 to use the bathroom, passed out and hit chin on the sink. Then vomited. Still low fever. Patient didn't receive treatment for events. Outcome of all events was recovering. The adverse events resulted in neither doctor or other healthcare professional office/clinic visit, nor emergency room/department or urgent care. The report was considered as non-serious. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
52 2021-02-02 chest pain, fast heart rate, excessive bleeding Bleeding/ gastro intestinal bleeding; Bleeding/ gastro intestinal bleeding; woke up with chest pain;... Read more
Bleeding/ gastro intestinal bleeding; Bleeding/ gastro intestinal bleeding; woke up with chest pain; tachycardia; body ache; headache; This is a spontaneous report from a contactable other HCP reported for self. A 52-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EJ1686), via an unspecified route of administration at left arm on 13Jan2021 12:00 PM (that is 14Jan2021 00:00) at SINGLE DOSE for COVID-19 immunization. No Covid prior vaccination. Medical history included allergy to shellfish and Iodine, Kidney and pancreas transplant 10 years ago. Concomitant medications in two weeks includes mycophenolate sodium (MYFORTIC), Tacrolimus, Prednisone, Trazodone. The patient previously received first dose of BNT162B2 (Lot number: EJ1686), at left arm on 24Dec2020 14:30. No Other vaccine in four weeks. On 14Jan2021 09:30 AM, patient woke up the next morning with chest pain, tachycardia, body ache, headache, bleeding. Symptoms lasted from Thursday to Monday. A total of 5 days. Patient have never suffered from a headache and as of 20Jan2021, patient still had it. Every day got better and no longer have the other symptoms. The only other one is the gastro intestinal bleeding. Patient only see few spots of blood when go to the bathroom. She believed that is gastrointestinal because almost never had a period as a teen. No treatment received. Not tested covid post vaccination. Outcome of "Bleeding", "Gastrointestinal bleeding" was not recovered, of "headache" was recovering, of other events was recovered.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events haemorrhage and gastrointestinal haemorrhage cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
52 2021-02-03 chest discomfort Day 6 I felt extremely lethargic, fatigued and with extreme joint pain upon waking. I took lunch at ... Read more
Day 6 I felt extremely lethargic, fatigued and with extreme joint pain upon waking. I took lunch at 3:30 pm consisting of almonds, cranberries and cheese bites and 2 mandarin oranges. Approx 10 minutes after eating I began to cough uncontrollably and had difficulty clearing my throat. Drank water thinking orange juice had gone down wrong. 10 more minutes my bottom lip began tingling, tongue felt thick, chest tightness, light headed. I called clinic who suggested I call for medical emergency because of my previous anaphylaxis. Taken to ED, given epi pen, prednisone, pepcid, monitored and discharged after 2 hours
52 2021-02-03 blood pressure increased Starting about an hour after the 2nd dose was administered she began experiencing severe nausea and ... Read more
Starting about an hour after the 2nd dose was administered she began experiencing severe nausea and vomiting, increased BP 133/77, pulse 110, temp 98.8 F. Symptoms resolved over several hours.
52 2021-02-03 palpitations Systemic: Headache-Severe, Systemic: Other- Heart palpitations, dry/burning lips, hand tremors-Mediu... Read more
Systemic: Headache-Severe, Systemic: Other- Heart palpitations, dry/burning lips, hand tremors-Medium; lasted 1 day
52 2021-02-03 blood pressure increased Within 10 mins I had swelling, tingling and some numbness in my face and neck. I was checked by EMS ... Read more
Within 10 mins I had swelling, tingling and some numbness in my face and neck. I was checked by EMS at the site. Waited another 20 mins and the symptoms did not get worse or rapidly improve. I had a prescheduled doctor appointment and went directly to the doctor's office after the vaccine. Dr. confirmed that I had swelling and redness in my face and prescribed Methylpredsisolone 4mg 21 pack of steriods to take. That medication removed the symptoms. On 02/01/21, 24 hrs after the last dose of the pack, the face swelling and tingling returned. As recommended I took Benedryl 2 tablets / 3 doses. I returned to Doctor's office on Tues 02/02 where she prescribed Presnisone 20mg for 5 days after seeing the swelling in my face and she said my lymph nodes were swollen as well.
52 2021-02-03 fast heart rate headache; dizziness; lack of appetite; extreme fatigue; tachycardia; swollen tongue; scratchy throat... Read more
headache; dizziness; lack of appetite; extreme fatigue; tachycardia; swollen tongue; scratchy throat; This is a spontaneous report from a contactable other hcp. A 52-years-old female patient received first dose of bnt162b2 (BNT162B2, lot number=EK9231), via an unspecified route of administration on 08Jan2021 16:00 on Left arm at SINGLE DOSE for COVID-19 immunisation. Medical history included hypertension, sero negative RA, Known allergies: Penicillin. Concomitant medication included amlodipine (AMLODIPINE). No covid prior vaccination. No other vaccine in four weeks. Adverse event: Initially the patient got tachycardia, swollen tongue and scratchy throat 08Jan2021 16:15. Next day (09Jan2021) extreme fatigue, headache, dizziness, lack of appetite. 10 days later, was still not better. AE resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. AE treatment included: Prednisone, 40 mg for 5 days, Benadryl 25 mg 2 x d. Covid test type post vaccination (Nasal Swab) on 13Jan2021 and 15Jan2021, was negative. The event outcome was not recovered.
52 2021-02-04 chest discomfort I had two episode of uncomfortable chest tightness about 7-8 hours after receiving the second dose; ... Read more
I had two episode of uncomfortable chest tightness about 7-8 hours after receiving the second dose; This is a spontaneous report from a contactable Other HCP (patient). A 52-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL 1284), via an unspecified route of administration in left arm on 12Jan2021 15:15 at second single dose for COVID-19 immunization. The patient medical history was not reported. No COVID prior vaccination. No known allergies. Concomitant medication included sertraline. No other vaccine received in four weeks. The patient previously tool first dose BNT162B2 (Lot number: EL 1284) on 22Dec2020 03:30PM in left arm for COVID-19 immunization. The patient had two episode of uncomfortable chest tightness about 7-8 hours after receiving the second dose. Adverse event start date/time: 12Jan2021 10:15 PM. No treatment received for AE. No COVID tested post vaccination. Outcome of the event was recovered in Jan2021.
52 2021-02-04 heart rate increased, palpitations Patient reports that her HR is elevated about 15 minutes post Pfizer COVID vaccine #2. HR at 112.... Read more
Patient reports that her HR is elevated about 15 minutes post Pfizer COVID vaccine #2. HR at 112. States she feels a little dizzy. Reports that, during the day, her resting HR is never "this high". Reports that she had COVID and did not have bad symptoms. Recovered from COVID, but then started to get palpitations. States that she has a rapid heart rate that is 120's after that. Follows up with cardiology. Had a Holter monitor, which showed that she had a lot of PVC's. Currently on metoprolol, which she took today. Heart sounds are regular, no murmurs. VSS throughout monitoring. Dizziness resolved after about 20 min. Left facility of her own accord without assistance.
52 2021-02-04 palpitations Pt reported heart racing. Denies all other symptoms: chest pain, shortness of breath and respirator... Read more
Pt reported heart racing. Denies all other symptoms: chest pain, shortness of breath and respiratory symptoms.
52 2021-02-07 loss of consciousness As described to this writer- patient was home at 11PM, got out of bed as she couldn't sleep and wen... Read more
As described to this writer- patient was home at 11PM, got out of bed as she couldn't sleep and went into the kitchen to make coffee. She states she woke up 15 minutes later and had lost consciousness. She went to her husband who said her words were slurred. She did not seek medical help until the following day when urged by her co-workers to do so. Then she brought a note back to work that stated she had a concussion and nothing of how or why she got the concussion. On February 4th i received a copy of her office visit that state she is alright to return to work and get the 2nd dose of vaccine with stipulations of having the following day off from work.
52 2021-02-07 chest pain At about 12 pm day of immunization patient began having the following symptoms: redness to neck and ... Read more
At about 12 pm day of immunization patient began having the following symptoms: redness to neck and front chest, injection site ( right arm) redness , itching, rash below and above injection, reports blood pressure 169/96 ( checked at site ) , dizziness with standing, denied shortness of breath or chest pain at that time. En route home began having mid sternal chest pain , radiated to left side of chest, checked blood pressure at home 175/100. Patient states took additional Benadryl 25mg PO . After Benadryl chest pain subsided. At this time reports headache, dizziness, vertigo, chills , and fever. Vital signs stable, patient aaox3, report to Occupational Health provider. No obvious distress noted.
52 2021-02-09 chest discomfort, heart rate irregular History of similar reactions with each flu vac. and therefore she stopped taking flu vacs. 5 years a... Read more
History of similar reactions with each flu vac. and therefore she stopped taking flu vacs. 5 years ago. Developed nausea, lightheadedness, headache, and shortness of breath 14 min after vaccine. Vital signs stable on admission to observation area and heartrate regular with apical auscultation. Forty-five min after vaccine, began having some chest pressure and tingling in her arms. Her heart rate irregular at 68 bpm. Employee called her cardiologist who advised her go to the emergency room. No history of angioedema.
52 2021-02-17 nosebleed chills; temp got to 103.5 (fever); swollen, sore glands to the left side of my jaw, underneath and i... Read more
chills; temp got to 103.5 (fever); swollen, sore glands to the left side of my jaw, underneath and in front of my ear; swollen, sore glands to the left side of my jaw, underneath and in front of my ear/gland pain; nasal drainage to my left sinus/nostril; inside of her left cheek felt like there were lesions breaking out but there were none; her cheek and teeth were sore, as if she had a sinus infection; her cheek and teeth were sore, as if she had a sinus infection; sinus drainage became blood tinged. It is pale pink in in color, not constant/bloody drainage; This is a spontaneous report from a contactable nurse (patient). A 52-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249, expiry date not reported), via an unspecified route of administration in the left arm on 18Jan2021 at single dose for COVID-19 immunization. Medical history included hypertension from an unspecified date and appendectomy in 1991. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a hospital. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medication included hydrochlorothiazide, lisinopril (LISINOPRIL AND HYDROCHLOROTHIAZIDE). The patient previously took atropine sulfate (SULFAS ATROPINE, reported as Sulfa), quinolones and doxycycline and experienced drug hypersensitivity. The patient previously received first dose of bnt162b2 (lot number: EL0142, expiry date not reported) in the left arm on 30Dec2020 at 5:30PM at single dose for COVID-19 immunisation. On 19Jan2021 02:00, she started with chills and by 24 hours, her temp got to 103.5 (fever). The patient took Tylenol. The temp stayed in the 100-101 range for the next 24 hours. Then, she started to have swollen, sore glands to the left side of her jaw, underneath and in front of her ear. The inside of her left cheek felt like there were lesions breaking out but there were none. She then had copious amounts of thin nasal drainage to her left sinus/nostril. Over the next few days, the gland pain subsided but she still had drainage and her cheek and teeth were sore, as if she had a sinus infection. She would occasionally take Tylenol and on occasion, took cold and flu medicine. Then, her sinus drainage became blood tinged. It was pale pink in in color, not constant, but when the drainage started, it was sudden and just drained with no warning. She smelled old blood. She turned in bed and the drainage occurred suddenly and she can taste old blood. Almost two weeks later, and she still had bloody drainage. Clinical outcome of the events was not recovered.
52 2021-02-21 nosebleed 16 hours after injection, had chills, temp 99.8, body aches that lasted about 16 hours. Then had 2 s... Read more
16 hours after injection, had chills, temp 99.8, body aches that lasted about 16 hours. Then had 2 small nosebleeds that lasted less than 1 minute-one about 48 hours after injection and one about 72 hours after injection. About 79 hours after injection, noticed petechiae on bilateral lower legs only . . Notified my PCP the next day. No nosebleed on day 4 after injection and petechiae stable - maybe spread a little but still below the knees. ( Had previous COVID-19 infection that symptoms started around 11/29/2020)
52 2021-02-21 palpitations Itching, swelling at injection site, pain, heart palpitations, lymph node swelling
52 2021-02-21 chest discomfort Patient arrived for 2nd dose of Pfizer vaccine. Administered with no difficulty. Approximately 20 mi... Read more
Patient arrived for 2nd dose of Pfizer vaccine. Administered with no difficulty. Approximately 20 mins after receiving vaccine, patient began to report shortness of breath and chest tightness and rash to chest, that continued to worsen. She was brought into the urgent care (on-site) and was evaluated by MD and urgent care team. Intravenous access was established, placed on cardiac monitoring and supplemental oxygen was administered. Benadryl, Pepcid, Epinephrine (2 doses), Solumedrol, normal saline intravenous transfusion was administered. SOB and chest tightness resolved, rash improved. Monitored in urgent care for additional 5 hours, discharged home with prednisone and epi-pen.
52 2021-02-22 chest discomfort "10min after vaccine, experiencing chest tightness and feeling SOB, BP 124/82 HR 44-86 with abnormal... Read more
"10min after vaccine, experiencing chest tightness and feeling SOB, BP 124/82 HR 44-86 with abnormal heart rhythm on auscultation O2 sat 100% temp 36.8 . She expresses tingling to the tips of her fingers, left shoulder pain radiated to her neck. DR in urgent care immediately notified and arrived . EKG ordered "
52 2021-02-22 hypertension, fast heart rate Tachycardia/high blood pressure hours after vaccine admitted to hospital.
52 2021-02-23 fast heart rate 1) injection 2/15 2) chills 2:00 am 2/16 fatigue rest of day 3) rapid heart rate, light headed 9 pm ... Read more
1) injection 2/15 2) chills 2:00 am 2/16 fatigue rest of day 3) rapid heart rate, light headed 9 pm 2/16 4) rapid heart rate woke me out of my sleep, call EMS, HR 160, BP 156/106, EKG normal. Resolved after 1 hr 5) rested for 2 day with episodes of tachycardia after walking up/down stairs. 6) 2/21 worked 2 hours became lightheaded, HR 106, BP 138/96, went to ER. All labs negative, EKG, negative. 7) continue fatigue 8) tachycardia 2/23 8 pm. lasted 20 min. HR 130
52 2021-02-24 chest discomfort Felt lightheaded, dizzy, hot clammy, feeling pressure in chest. HR down to 28. BP 90/40. Laid on bac... Read more
Felt lightheaded, dizzy, hot clammy, feeling pressure in chest. HR down to 28. BP 90/40. Laid on back with feet elevated. 911 called. EMS evaluated and pt was better and signed for no transport.
52 2021-02-25 fast heart rate Numbness in jaw, lips, neck on left side. Tachycardia
52 2021-02-27 chest pain SOB, chest pain, numbness, tingling in mouth, nausea, weak. Cleared by EMS
52 2021-02-28 heart rate increased Anaphylaxis developed over the hours, preceded by confusion, rapid heart rate, tingling of face/arm... Read more
Anaphylaxis developed over the hours, preceded by confusion, rapid heart rate, tingling of face/arms/chest, and feeling like moving through water.
52 2021-02-28 fainting, heart rate increased Fainted Fast heart rate Headaches Dizziness
52 2021-03-02 chest pain, palpitations chest pain; her lips were swollen/it is on and off; Palpitations off and on; she had a rash on her a... Read more
chest pain; her lips were swollen/it is on and off; Palpitations off and on; she had a rash on her arms; she had an abnormal feeling in her throat/abnormal feeling in her throat comes and goes, off and on; maybe she is nervous and anxious; maybe she is nervous and anxious; This is a spontaneous report received from a contactable consumer (patient). A 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on the left deltoid, on 19Dec2020, at single dose, for prevention/COVID-19 immunization, at the hospital. Medical history included allergies and allergies to propylene glycol 3350, polysorbate 20, polysulfate 20. It was reported that the patient had a "quick test" and confirmed she has allergies to propylene glycol and polysulfate 20. Her allergist gave her a list of things to stay away from and said to avoid those ingredients. She stated that COVID-19 vaccine has propylene glycol 3350. She clarified and said her allergist told her to stay away from propylene glycol products. Her allergist told her not to use the COVAX. On 19Dec2021, the patient got her first vaccine shot. Within 3 minutes of getting the vaccine, she had rash on her arms. 3 hours later, she had an abnormal feeling in her throat. She was told to go the emergency room and she was given a quick medicine (unspecified). The patient was unable to clarify what medication she received at the emergency room. On 20Dec2021 (the next day), her lips were swollen, on and off. The patient stated she uses dark shampoo and conditioners and maybe it has PEG in it or maybe she is touching something at the hospital. On 20Dec2020, the patient experienced palpitations. She asked the doctors and nurses about her palpitations and they said maybe she was nervous and anxious since she had a COVID patient in the unit. The patient reported that she thinks palpitation started when she went to pick up over the counter medications on 20Dec2020. On 02Jan2021, the patient experienced chest pain. The outcome of rash and palpitations were recovering; oropharyngeal discomfort, lip swelling, and chest pain were not recovered; and nervousness and anxiety were unknown. Information on the Lot/batch number has been requested.
52 2021-03-03 loss of consciousness Day 1, 26 Feb 2021; headache began at noon; severe fatigue at 6:00 pm; 103 degree fever at midnight ... Read more
Day 1, 26 Feb 2021; headache began at noon; severe fatigue at 6:00 pm; 103 degree fever at midnight Day 2, 27 Feb 2021: 103 fever for 3 hours, reduced and maintained at 100 with alternating extra strength Tylenol with 800 mg Motrin every 4 hours; continued severe fatigue; continue headache, nausea started at 5:00 pm Day 3, 28 Feb 2021: Nausea, diarrhea, muscle pain, vomiting, headache, 100 degree fever for 24 hours, 6:00 pm passed out for less than 1 minute when standing to go to bathroom to vomit (aware, controlled fall); 2nd episode of passing out sometime after midnight, tried to stand, completely blacked out, woke up disoriented, called 911, transported to ER; bruised upper left arm, left side jaw/neck hitting furniture in fall, hit head on floor
52 2021-03-04 heart rate increased At Approximately 1140, patient finished getting her 1st dose vaccine Pfizer (Lot# 6201 Exp. 06/2021... Read more
At Approximately 1140, patient finished getting her 1st dose vaccine Pfizer (Lot# 6201 Exp. 06/2021) and went to EMT observation area. At approximately 1210, patient informed EMT that she was not feeling well. Patient was given the zero gravity chair to sit in. Per EMT, patient c/o fast heart beat. EMT took vitals and assessed patient: BP systolic of 128, HR 88, pupils equally reactive, LOC X4, skin warm, RR of 8. Per EMT, patient was anxious and complaining of discomfort from occipital area of her head and nape. Per EMT, patient was instructed to do deep breathing exercises and patient was given some ice to initiate vagal response. Approximately 15-20 mins later, patient complained that she was not feeling well. At 1235 EMT came over to lead RNs stating that she was having difficulty getting an accurate BP reading due to the lack of having the proper size of BP cuff onsite. RN used personal BP cuff to take patient's vitals. Per RN, At 1238, patient's BP was 170/100, HR 88, RR 12, regular breathing. Per RN, Patient c/o swollen tongue, throat itchiness, and feeling cold, patient's skin showed visible cold urticaria. After assessment, RN instructed RN to call 911. EMT gave report to 911 operator. After the medics were on their way to site, Patient insisted needing to go to the bathroom to urinate, RN and EMT assisted patient to the bathroom. Patient was ambulatory. At 1244 Fire paramedics and AMR arrived. Patient relayed to medics that her tongue is swollen, that she is feeling itchiness in her throat, and that she has a raspy voice. Medics gave patient Benedryl IM in L arm at 1248. Patient refused to be transported to a hospital per Medics recommendation. Patient signed documents declining further medical care. Patient was instructed to call 911 for any difficulty breathing and any throat swelling. Medics and AMR left at 1258. At 1300 niece came from parking lot to assist patient to go to her car to go home.
52 2021-03-04 palpitations Patient complaining of heart palpitations that started 24 hours after the administration of the vacc... Read more
Patient complaining of heart palpitations that started 24 hours after the administration of the vaccine. Patient still having palpitations today, patient states that the intensity of the palpitations have decreased since they first started on 3/2/2021. Patient also complained of shortness of breath that started first at rest and then the patient noticed that when going up the stairs she felt really out of breath that she had to lay down and rest. Patient also had two episodes of dizziness on 3/4/2021.
52 2021-03-04 loss of consciousness Patient rec'd vaccine at 1400. She went to wait her 15 minutes in the car and after about 10 minutes... Read more
Patient rec'd vaccine at 1400. She went to wait her 15 minutes in the car and after about 10 minutes noticed eye sensitivity and headache. When symptoms did not pass after an additional 10 minutes she came back into the office. While waiting when her husband was checking her in, she "passed out." Episode lasted less than 1 minute. She was easily oriented to person, place and time. It was noted that she had some swelling to bilateral eyes. Patient was brought back to room, VS were checked and all were normal. She denied any chest pain, shortness of breath, wheezing, tongue swelling, itching, or tickling sensation to back of the throat. She was able to tolerate sips of water without difficulty. 50mg benadryl IM was given in the left deltoid. Approximately 5 minutes after IM injection patient again "passed out." She was seated at the time and slumped to her right, resting her head on her husband and did not fall from chair. She aroused after approx 2 minutes, and was a/ox4. VS were rechecked and were O2 99% on RA. HR 101, BP 124/88, RR20, temp 98.5/oral. Patient stayed at the clinic for an additional 45 minutes after which her eyesight was reported to be back to normal, her headache had improved and the lower eye edema had resolved. It should be noted that both the patient and the husband were not concerned with her "passing out." She states it happens because of pain and she was fearful of the injections. Patient also states that her neurologist told her that when "she is in too much pain, she will pass out."
52 2021-03-04 palpitations palpitations; Soreness for 2.5 days; it is red and bruised/Redness; Swelling in the injection area; ... Read more
palpitations; Soreness for 2.5 days; it is red and bruised/Redness; Swelling in the injection area; bruise at the injection site/bruising is about the size of a half dollar or a little bigger/bruising was purple; Warm to touch/feels hot to touch; She felt pain immediately from the injection; This is a spontaneous report from a contactable consumer. A 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262), via an unspecified route of administration on 12Feb2021 at a single dose on right arm for COVID-19 vaccination. Medical history included history of reactions to vaccination (including swelling), cardiovascular disease and she had 3 stents placed in the last 3 years, ongoing coronary artery disease, small vessel disease, heart attack (when she was 50 years old. She has been having symptoms in the last could of years), blood pressure, angina, and high cholesterol. Concomitant medication included ticagrelor (BRILINTA) as blood thinner, ranolazine (RANOLAZINE EXTENDED RELEASE) for angina, rosuvastatin for high cholesterol, losartan for blood pressure, metoprolol to help her heart not work as hard, ezetimibe as cholesterol booster, and acetylsalicylic acid (ASPIRIN) as blood thinner. The patient experienced palpitations on an unspecified date which resulted in a recent hospitalization. The patient was reported to have taken the first dose of COVID-19 vaccine on 12Feb2021 and had soreness for 2.5 days since an unspecified date, then it resolved. She reported that she felt pain immediately from the injection on 12Feb2021 and some pain after the injection and she typically have reactions where she swells. On 20Feb2021, she developed a bruise at the injection site, and it was also warm to touch. The bruising was the size of a half dollar and it was hot to touch. She stated that the bruising was purple, and she never experienced that before. She wanted to know if this could be due to the vaccine. on 12Feb2021. On 21Feb2021, she had swelling in the injection area, it is red and bruised, and the bruising was about the size of a half dollar or a little bigger. The redness looked like it was a little less, but the bruising has been more prominent. She wanted to know if she should get the second dose on 05Mar2021, as scheduled, and if she does, will the reaction be worse? The patient underwent lab tests and procedures which included exploratory tests: which revealed small vessel disease on an unknown date. The outcome of the event "Soreness for 2.5 days" was recovered; "She felt pain immediately from the injection", "it is red and bruised/Redness" was recovering; and "bruise at the injection site/bruising is about the size of a half dollar or a little bigger/bruising was purple", "Warm to touch/feels hot to touch" and "Swelling in the injection area" was not recovered, and for palpitations was unknown.
52 2021-03-15 chest pain Patient woke with severe chest pain and difficult to take deep breaths. Chest pain extended over he... Read more
Patient woke with severe chest pain and difficult to take deep breaths. Chest pain extended over her shoulder and around her neck. Pain worsened during the day, went to ER, found to have positive troponins and subsequent ecg were abnormal. Echo was negative and angiogram showed no blocked arteries. Cardiologist diagnosed her with pericarditis
52 2021-03-17 chest discomfort ACC Note: ADULT EMREGENCy retrived from the COVID vaccine tent. Pt states lightheadedness and upper... Read more
ACC Note: ADULT EMREGENCy retrived from the COVID vaccine tent. Pt states lightheadedness and upper chest/throat discomfort. TENT NOTE: PT. COMPLAINED OF TIGHTNESS IN UPPER CHEST AND FEELING FLUSHED. ASSISTED TO GURNEY AND ADULT EMERGENCY CALLED
52 2021-03-20 cerebrovascular accident SEVERE VESTIBULAR STROKE. Complete occlusion. Patient is now in Rehab trying to regain her ability t... Read more
SEVERE VESTIBULAR STROKE. Complete occlusion. Patient is now in Rehab trying to regain her ability to swallow properly, see without double vision, and walk again.
52 2021-03-21 chest discomfort c/o chest tightness, throat swelling and flushing
52 2021-03-28 cardiac arrest Patient had fever after vaccine then later in the day suffered a cardiac arrest
52 2021-04-06 fainting, hypertension, fast heart rate fainting; dizzy; tachycardia; high blood pressure; then numbness to left side of face swelling then ... Read more
fainting; dizzy; tachycardia; high blood pressure; then numbness to left side of face swelling then progressed to left arm left leg with excessive pressure to head; then numbness to left side of face swelling then progressed to left arm left leg with excessive pressure to head; then numbness to left side of face swelling then progressed to left arm left leg with excessive pressure to head; then numbness to left side of face swelling then progressed to left arm left leg with excessive pressure to head; This is a spontaneous report received from a contactable nurse (patient). A 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on 12Mar2021 at 09:30 (at the age of 52 years) at a single dose in the left arm for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient had no allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination. On 12Mar2021, the symptoms the patient had were fainting, feeling dizzy, tachycardia, high blood pressure, then numbness to left side of face swelling then progressed to left arm left leg with excessive pressure to head. The events resulted to doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient did not receive any treatment for the events (as reported). Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered with sequel in Mar2021. Information on the lot/batch number has been requested.; Sender's Comments: A contributory role of BNT162B2 to event fainting cannot be excluded based on temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
52 2021-04-06 fainting, blood glucose increased weakness; nausea/her stomach is kind of queasy; She spent 2 days in bed, unable to get out to do any... Read more
weakness; nausea/her stomach is kind of queasy; She spent 2 days in bed, unable to get out to do anything other than pee, get something to eat and go back to bed; brain fog; she can't concentrate, it is affecting her head; dizziness/dizzy; exhausted/tiredness/tired; faint episode; achy arm; abdominal pain; her sugars really shot up in couple of hours, went to 220s; shivers, cold.; shivers, cold.; The initial safety information received was reporting only non-serious adverse drug reaction(s), Upon receipt of follow-up information on [22Mar2021], this case now contains serious adverse reaction(s). Information processed together. This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received the first dose of bnt162b2 (PFIZER BIONTECH COVID-19, Lot number and expiry date were not reported), via an unspecified route of administration, administered in left arm on 18Mar2021 (at the age of 52-year-old) at single dose for COVID-19 immunization. Medical history included Diabetes, ongoing PoTS diagnosed around Dec2020 or Jan2021, MTHFR (methylenetetrahydrofolate reductase genetic mutation) genetic mutation, Genetic/Chromosomal abnormalities and lost some weight. The patient had prediabetes for long time, in last year gotten little bit bad; back under control sugars running 125-130. That's not why she is feeling like this. Measures her sugar 3 times daily keeps Diabetes diet controlled mostly. With regards to her MTHFR: methylenetetrahydrofolate reductase genetic mutation. This genetic mutation makes her not methylate well, they told her she is a poor meythelator. Family history included diabetes and high blood pressure. Her dad passed away from either Diabetes or Lung cancer; she is not sure which-he had lung cancer but afterwards when patient talked to her sister, sister mentioned dad's diabetes got really bad after the chemo and everything; but that is neither here nor there in the end; it could have been from Diabetes or lung cancer. He was a smoker for his entire life, even though chemo he could not quit the cigarettes, could not give it up even on his death bed. Concomitant medications included ergocalciferol (VIT D), cyanocobalamin (VIT B12), and ongoing ascorbic acid (VITAMIN C); all were taken for vitamin supplementation. The patient previously received varicella zoster vaccine rge (cho) (SHINGRIX) on 19Feb2021 for immunization and experienced achy arm and tired for a day. About 15 years ago when having her daughter, the patient had severe reaction to Magnesium sulfate for preeclampsia. They gave her Magnesium sulfate twice which made her comatose twice, she does not know why they gave it to her the second time. She also had a reaction to calcium levomefolate (DEPLIN), like a methylfolate thing. She reported she was on Glimepiride for Diabetes previously which was stopped a couple of weeks ago because she was having a lot of blood sugars that did not sit well with her. This consumer is the patient who called regarding symptoms she experienced following first dose of Pfizer-BioNTech COVID-19 Vaccine administration on 18Mar2021. The first symptoms she had were an achy arm later on that day of 18Mar2021. On 19Mar2021, the next morning she woke up totally exhausted. She spent 2 days in bed, unable to get out to do anything other than pee, get something to eat and go back to bed. Some of the symptoms lifted yesterday, 21Mar2021 during the day. She kind of got up, was still kind of tired but pushed through it thinking she couldn't just sit in bed. She spent a little time outside while her daughter was at the pool; she was sitting in a chair away from other people. When she came home she was really tired and dizzy on 21Mar2021 and decided to go to bed. The patient also experienced weakness and nausea on unspecified date. After the Pfizer BioNTech COVID-19 Vaccine injection/shot on Thursday, 18Mar2021 she had a faint episode. They thought the faint episode was probably from anxiety, reason unknown; but she had a lot of faint episodes before she went to bed. She woke up 1-2 hours later on 18Mar2021 with really bad abdominal pain all night, shivers, cold. When she got up in the morning she was really tired; she had to take her daughter to school and barely drove to school half-way coherent because her daughter was talking to her. She was not doing great, she came back home, she is still tired, has been on the couch all day; her stomach is kind of queasy, not good. This is day 4 so she is concerned a little bit. She is too tired to go downstairs during this call; this thing is kicking her butt; she is having a brain fog with this thing, she can't concentrate, it is affecting her head. She has other medical condition Diabetes: After she got the Pfizer-BioNTech COVID-19 Vaccine her sugars really shot up in couple of hours, went to 220s on 18Mar2021; sugars back down the next day (19Mar2021). She is terrified of what is going to happen after the second dose of Pfizer-BioNTech COVID-19 Vaccine. She verified she has not had any visit to physician's office, emergency room or hospitalization related to these events; not yet, but she is considering whether to go or not. The outcome of the event exhausted/tiredness/tired was not recovered, and the outcome of the remaining events was unknown. Information about the Lot/batch number has been requested.
52 2021-04-08 heart rate increased, hypertension Anaphylaxis fast heart beat sob like being on fast treadmill tongue swelling super high blood pressu... Read more
Anaphylaxis fast heart beat sob like being on fast treadmill tongue swelling super high blood pressure the next two days after I had really bad migraine and high fever of 102.3° with bad fatigue for 4 days.
52 2021-04-09 palpitations, fast heart rate, chest pain got extremely weak, very weak in the shower and didn't know if she will be able to keep standing up;... Read more
got extremely weak, very weak in the shower and didn't know if she will be able to keep standing up; chest pain in my right side; my left leg started aching; my toes tingle like they have fallen asleep on that left side; heart was beating faster than what it should have been, they said she was tachycardic and her heart was racing; heart was beating faster than what it should have been, they said she was tachycardic and her heart was racing; Redness; back was all red, really red; The initial case was missing the following minimum criteria: unspecified product. Upon receipt of follow-up information on 01Apr2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer reporting for herself. This 52 years old female patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EP7533) on 31Mar2021 at 09:30, for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient received the vaccine on 31Mar2021 at 9:30 and was fine all day until 7 o'clock at night. She went to take her shower and got extremely weak, very weak in the shower and didn't know if she will be able to keep standing up, so she got out of the shower, went upstairs; the weakness persisted and then she started feeling chest pain in her right side, her left leg started aching and her toes tingled like they had fallen asleep on that left side so she got scared and went to the emergency room where they kept her overnight. Her heart was beating faster than what it should have been, they said she was tachycardic and her heart was racing and that was why they kept her at the hospital. She also had redness, her back was all red, really red. They did lots of lab work and blood work, a stress test, an ultrasound on her left leg for blood clot and a CAT scan on her heart, all with unknown results. When probed about hospitalization, she stated to stay overnight. She was hospitalized on 31May2021 at about 19:30 and did not get out until 13:30 on 01Apr2021. Events outcome was unknown.
52 2021-04-13 chest discomfort, fibrin d dimer increased PT VOICED SHE TOOK PFIZER VACCINE THIS PAST FRIDAY (4/9/21). LATER THAT EVENING SHE BEGAN HAVING COV... Read more
PT VOICED SHE TOOK PFIZER VACCINE THIS PAST FRIDAY (4/9/21). LATER THAT EVENING SHE BEGAN HAVING COVID-LIKE SYMPTOMS AND RIGHT SIDE CHEST PRESSURE (ON/OFF). ON 4/12/21 SHE BEGAN HAVING NAUSEA AND VOMITING AND COULDN'T KEEP ANYTHING DOWN SO SHE DECIDED TO CALL HER PCP. SHE WAS ADMITTED TO THE HOSPTIAL ON 4/13/21. PT VOICED SHE DIDN'T HAVE ANY PROBLEMS OR SYMPTOMS BEFORE SHE RECEIVED THE VACCINE.
52 2021-04-14 chest discomfort Client was in observation for 15 minutes after vaccine, walking to car when client started to feel "... Read more
Client was in observation for 15 minutes after vaccine, walking to car when client started to feel "throat tightness and difficulty swallowing" and returned to observation area with husband. Client also reported chest pressure while walking to observation area. Client reports this also happened with first COVID vaccine 3 weeks ago. Vital signs stable, able to have conversation and answer questions. RN offered Benadryl, client declined. Chest pressure resolved, throat tightness stayed the same. Client left home with husband.
52 2021-04-14 blood pressure increased, palpitations Patient received second dose of Pfizer COVID-19 vaccine. Patient stated she felt dizzy, heart was ra... Read more
Patient received second dose of Pfizer COVID-19 vaccine. Patient stated she felt dizzy, heart was racing, and feeling not well. Patient took Benadryl for the nausea and stated she felt slightly better. Patient was advised by doctor, if blood pressure increases to take Metoprolol which she took half a dose. EMT was called and patient blood pressure was elevated and they could not get blood pressure to drop. EMT advised patient to go to the emergency room and EMT escorted patient.
52 2021-04-17 nosebleed Blood was coming out both nostrils and down throat and could not be stopped without intervention; we... Read more
Blood was coming out both nostrils and down throat and could not be stopped without intervention; went to emergency room with gushing bloody nose that would stop. Blood was coming out both nostrils and down throat and could not be stopped without intervention; Bruising also noticed on arm and leg; This is a spontaneous report from a contactable HCP (patient). A 52-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 25Mar2021 12:00 (Lot Number: EP7534) as SINGLE DOSE for covid-19 immunisation. Medical history included Allergic to penicillin (body rash). Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. Concomitant medication(s) included fexofenadine hydrochloride (ALLEGRA) for Allergy pills and multi-vitamins. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took bnt162b2 dose 1 in arm left on 04Mar2021 (lot number: EN6198) for covid-19 immunization. The patient experienced blood was coming out both nostrils and down throat and could not be stopped without intervention, went to emergency room with gushing bloody nose that would stop, bruising also noticed on arm and leg on 30Mar2021 16:00. Reported as: On Tuesday 30Mar2021 went to emergency room with gushing bloody nose that would stop. Blood was coming out both nostrils and down throat and could not be stopped without intervention. Bruising also noticed on arm and leg. Bleeding resumed after returning home from ER, used Afrin to stop (Afrin up both nostrils). Now stabilize. The adverse event result in Emergency room/department or urgent care. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering. No follow-up attempts are needed. No further information is expected; Sender's Comments: The events "blood was coming out both nostrils and down throat" most likely represent intercurrent medical conditions that are assessed as unrelated to BNT162B2. The case will be reassessed when additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified.
52 2021-04-20 excessive bleeding, troponin increased COVID pneumonia; Hematological; bleeding; having hemoxysis; slight troponin increase; GI bleed; head... Read more
COVID pneumonia; Hematological; bleeding; having hemoxysis; slight troponin increase; GI bleed; headaches; COVID-19 test was positive; COVID-19 test was positive; nauseous; abdominal discomfort; body aches; This is a spontaneous report from a contactable physician. A 52-year-old female patient received her first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration at the age 52-year-old on 12Mar2021 at single dose for COVID-19 immunisation. Medical history included hemodialysis for many years, adherent to medical care, multiple DVTs and Pes (On anticoagulants), morbid obesity, Patient was on dialysis for renal failure and had lupus anticoagulant (positive), Afib, allergic to shellfish. Family history included renal failure and had lupus anticoagulant. Concomitant medications included warfarin sodium (COUMADIN); metoprolol; amitriptyline; calcitriol; ergocalciferol (VIT D); calcium; calcium acetate (PHOSLO); amiodarone; albuterol. The patient previously allergic to Cipro, clindamycin, doxycyclin, Lyrica, tetracycline. The patient previously was non-responder to hepatitis B vaccine. The patient previously received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE) on 17Feb2021 for COVID-19 immunisation. The patient hasn't been treated with immunomodulating or immunosuppressing medications or received any other vaccines around the time of COVID-19 vaccination. The patient wasn't smoker/ former smoker. There was no any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. A nephrologist who reported patient in her hemodialysis unit who were vaccinated with BNT162b2 but were recently diagnosed with COVID-19. More detail is below on each patient. The patient COVID results were sent to the local health department for genetic sequencing (pending) and SARS titers were drawn (pending). Unfortunately, the HD unit does not have B/L information (although the B/L # was put on the patient's COVID vaccine cards, a record was not kept in the HD unit). Day she came in for dialysis she was already short of breath she said she'd had body aches for 5 days, got short of breath on 05Apr2021. The day before, started getting cough, nauseous, chills, abdominal discomfort on 04Apr2021. The patient was sent to the ER from dialysis and was admitted for SOB on 05Apr2021 and passed away on 09Apr2021 due to a GI bleed. Patient is over 500lbs so was unable to fit into hospital imaging equiment for CT scans or weight measurements. COVID-19 test was positive on 05Apr2021; the patient experienced COVID pneumonia on 05Apr2021. The patient admitted on 05Apr2021 to regular floor. The patient was moved to an Intensive Care Unit on 06Apr2021. The patient experienced short of breath on 05Apr2021 and required much more O2 than normal. Sometimes required BP support while on Dialysis and BP was 113/61 in ER. Pressure dropped to 100/70 and required mitrodrine after fluid was removed. The patient needed 4 liters supplemental O2 vs. only needing 2 liters at home. The patient experienced tachypnea and hypoxemia and no Respiratory failure. Respiration was 22. After 5 litres of O2 improved. Pulse 93 in ER. Cardiovascular: There was no heart failure, cardiogenic shock, Acute myocardial infarction, arrhythmia and myocarditis. The patient Had chest pain which resolved when O2 was administered. Gastrointestinal/Hepatic: There was no Vomiting, Diarrhea. The patient experienced nausea but no vomiting or diarrhea and complained of abdominal pain. There was no Jaundice and acute liver failure. Neurological: There was no altered consciousness, altered consciousness, encephalopathy, meningitis and cerebrovascular accident. The patient had headaches a couple days before admitting to ER. Hematological: There was no Thrombocytopenia, Disseminated intravascular coagulation. INR was 3 due to large dose of coumadin, and platelets were 180 and white count 6.8. Slight troponin increased at 0.37 at admittance, BNP 39. The patient started coughing up blood, having hemoxysis and bleeding on unspecified date. Laboratory test or diagnostic studies was reported that test for SARS-CoV-2 by PCR, or other commercial or public health assay. Xray showed vascular congestion with superimposed infiltrate which could represent pneumonia. Blood count was 11 and 36.7% at ER. Clinical chemistry: Sodium was 133; BUN was 68; Creatinine was 10. Evidence of hypoxemia: Pulse oO2 was 90 in ER. CT scans: unknown results. Urinalysis: On dialysis so does not make urine. The patient had received Remdesivir, from 06Apr2021, Hydroxychloroquine/chloroquine, Azithromycin from 06Apr2021 and Corticosteroids from 06Apr2021 for COVID-19. The outcome of event "GI bleed" was fatal, the event "chest pain" and "body aches" was recovered and other events was unknown. The patient died on 09Apr2021. An autopsy was not performed. Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, a contributory role of the suspect drug cannot be excluded for the events vaccination failure, COVID-19, COVID-19 pneumonia, and sepsis. However, the patient's multiple medical comborbidities including renal failure requiring dialysis, lupus, and morbid obesity along with the risk of COVID-19 infection in light of the current pandemic are the more likely explanations for the development of these infections. The events gastrointestinal hemorrhage, hemorrhage, hemolysis and troponin increased are attributed to intercurrent medical conditions, and are considered unrelated to the suspect drug. The patient is currently on warfarin which may increase the risk for bleeds. This case will be reassessed upon receipt of additional information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: GI bleed
52 2021-04-23 chest pain All of the joints in both arms ached/the joints in my left arm are sore; my left hip aches; As the e... Read more
All of the joints in both arms ached/the joints in my left arm are sore; my left hip aches; As the evening progressed the throbbing pain spread across my pectorals, up to my chin, and all the way to my other arm; As the evening progressed the throbbing pain spread across my pectorals, up to my chin, and all the way to my other arm; As the evening progressed the throbbing pain spread across my pectorals, up to my chin, and all the way to my other arm; vaccine site started being sore; This is a spontaneous report from a contactable consumer/ Non-HCP (patient). This 52-year-old non-pregnant female consumer received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date not reported) via unknown route of administration, in the left arm, on 12Feb2021at 09:30 AM (age at the time of vaccination 52 years), at single dose for COVID-19 immunisation in the hospital. Patient's medical history included hypothyroidism, irritable bowel syndrome, primary hypertension, seasonal affective depression and flu. Patient had no known allergies. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date not reported) via unknown route of administration, in left arm on 22Jan2021 at 09:30 AM (age at the time of vaccination 52 years), at single dose for COVID-19 immunisation in the hospital. The patient had no allergies with medications, food or other products. Concomitant medications in two weeks included levothyroxine sodium(thyroxine), sertraline, hyoscyamine and lisinopril. On 12Feb2021, the patient was a little sore that day, but not the next, vaccine site started being sore. On 14Feb2021 patient spent an hour shoveling snow in the morning, but wasn't sore afterwards. On 14Feb2021 (8 plus hours after shoveling snow), the vaccine site started being sore, but the pain was on again/off again. As the evening progressed the throbbing pain spread across my pectorals, up to my chin, and all the way to my other arm. All of the joints in both arms ached, 600 mg ibuprofen didn't seem to help. On 15Feb2021(Morning), the injection site is a little sore, the joints in her left arm are sore, and, weirdly, her left hip aches. The throbbing pain last night wasn't like any over-used muscle soreness I've ever experienced and the joint aching was also unlike anything I've experienced outside of when I've had the flu. Patient did not receive other vaccines within 4 weeks or prior vaccination. No COVID-19 prior the vaccination and no COVID-19 test was done post vaccination. Patient's treatment medication included ibuprofen. Outcome of the events were recovering. Information on the lot/batch number has been requested.
52 2021-04-26 blood clot swelling in her right foot and right calf and pain/blood clot was diagnosed in her right calf under ... Read more
swelling in her right foot and right calf and pain/blood clot was diagnosed in her right calf under her knee; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received the second dose of bnt162b2, via an unspecified route of administration, administered in left arm on 31Mar2021 (Lot Number: ER8732) as single dose for covid-19 immunisation. There were no medical history and concomitant medications. The patient previously received the first dose of bnt162b2, at the age of 52-year-old, via an unspecified route of administration, administered in left arm on 10Mar2021 11:15(Lot Number: EN6206) as single dose for covid-19 immunization. Started experiencing swelling in her right foot and right calf and pain 3 days following 2nd injection (03Apr2021). Went to the doctor and blood clot was diagnosed in her right calf under my knee 9 days following 2nd injection (09Apr2021). Event resulted in Doctor or other healthcare professional office/clinic visit, Life threatening illness (immediate risk of death from the event). The treatment for event was 21 Days Xarelto BID then Pradaxa for 90 days. The patient was not pregnant. The outcome of the event was recovering.
52 2021-04-27 blood pressure increased Fluid in the ears causing dizziness and elevated blood pressure; Heavy blood flow during menstruatio... Read more
Fluid in the ears causing dizziness and elevated blood pressure; Heavy blood flow during menstruation period with severe multi-day cramps; Fluid in the ears causing dizziness and elevated blood pressure; Fluid in the ears causing dizziness and elevated blood pressure; This is a spontaneous report from a contactable consumer (patient). This 52-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) (Batch/Lot number was not reported), via an unspecified route of administration on 18Mar2021 at 14:45 (at age 52-years-old) as a single dose for covid-19 immunisation. Medical history included facioscapulohumeral (FSH) muscular dystrophy from an unknown date and unknown if ongoing and drug hypersensitivity (sulfa drugs) from an unknown date and unknown if ongoing. Concomitant medications included olmesartan medoxomil (BENICAR) taken for an unspecified indication, start and stop date were not reported; and metoprolol (METOPROLOL) taken for an unspecified indication, start and stop date were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Mar2021, the patient experienced fluid in the ears causing dizziness and elevated blood pressure, and heavy blood flow during menstruation period with severe multi-day cramps. The adverse events resulted in an emergency room/department or urgent care visit. The patient underwent lab tests and procedures which included blood pressure measurement (30Mar2021): elevated. Therapeutic measures taken included unspecified medication. Clinical outcome of the events fluid in the ears causing dizziness and elevated blood pressure, and heavy blood flow during menstruation period with severe multi-day cramps was resolving. It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible; information about lot/batch number cannot been obtained.
52 2021-04-27 pulmonary embolism Pulmonary embolism; Shortness of breath; she tested positive for Covid; she tested positive for Covi... Read more
Pulmonary embolism; Shortness of breath; she tested positive for Covid; she tested positive for Covid; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program. A 52-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 52 years of age), dose 1 via an unspecified route of administration on 20Mar2021 12:00 (Batch/Lot Number: ER8727; Expiration Date: 31Jul2021) as a single dose for COVID-19 immunisation. Medical history included allergies wherein she mentioned that her allergies were acting up so she took Tylenol 500mg, 1 pill; and insomnia. Concomitant medications included paracetamol (TYLENOL) taken for hypersensitivity; cetirizine hydrochloride, pseudoephedrine hydrochloride (ZYRTEC DUO) taken for hypersensitivity, start and stop date were not reported; and dextromethorphan hydrobromide, doxylamine succinate, ephedrine sulfate, ethanol, paracetamol (NYQUIL) taken for insomnia (it helps her sleep at night), start and stop date were not reported. It was reported that the patient already received 1st dose of the Pfizer-BioNTech Covid-19 Vaccine and was scheduled to receive the 2nd dose on 17Apr2021. Yesterday, she tested positive for Covid and got hospitalized. She said she got discharged today and is now on medication which includes a blood thinner. She wanted to know if she needed to reschedule her 2nd dose, and how. It was clarified that the patient had Covid test on 12Apr2021 with Positive result. She mentioned that she was reading paperwork and it said something about to let her vaccination provider know about medical conditions, allergies, bleeding or if she take blood thinners. She stated that she was prescribed blood thinners yesterday evening and she was going to be taking them for 3-6 months. She questioned if it was going to affect if she takes the shot on Saturday. She added that she will be on the blood thinner 5-6 days by then. She stated that she was tested for Covid in the hospital that she went in with shortness of breath and they did the test yesterday. She had shortness of breath Saturday (09Apr2021) and she went to the ER on 12Apr2021 and was admitted and was released 13Apr2021. She stated that she was diagnosed from being discharged with blood clots and she is now on a blood thinner and a steroid pill for inflammation. She clarified that she was diagnosed on 12Apr2021 with pulmonary embolism and was put on ELIQUIS and will take it for the 1st 7 days, 2 tablets twice a day and they are 5mg each and then she will take 1 tablet twice a day until she follows up with her primary doctor and will either stop taking it at 3 months or 6 months. She will also be taking Dexamethasone 2mg tablet taking 3 tablets once a day for 8 days. She stated that they did a C scan to identify blood clots. There was no other vaccine administered on the same date the Pfizer vaccine was given. The outcome of events was unknown.
52 2021-04-28 blood clot blood clot; swelling and pain in right leg; swelling and pain in right leg; right arm hurting tremen... Read more
blood clot; swelling and pain in right leg; swelling and pain in right leg; right arm hurting tremendously; This is a spontaneous report from a contactable Nurse. A 52-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 01Apr2021 13:45; at the age of 52-years-old, (Batch/Lot Number: ER8734) as SINGLE DOSE for covid-19 immunisation. Medical history included ongoing hypertension, ongoing memory impairment (She states that she was diagnosed either last year or the year before that she can't remember. She states that it is ongoing, but it is well controlled). Historical vaccine included vaccine to tetanus (About 3 or 4 years ago). There were no concomitant medications. The patient experienced blood clot (thrombosis) (disability) on 13Apr2021 with outcome of not recovered, swelling and pain in right leg (disability, medically significant) on 09Apr2021 with outcome of not recovered, right arm hurting tremendously (disability) on 01Apr2021 with outcome of recovered on 04Apr2021. The patient underwent lab tests and procedures which included ultrasound scan: positive on 13Apr2021 had a blood clot. Therapeutic measures were taken as a result of blood clot (thrombosis) included Xarelto and due to pain in extremity the patient received ibuprofen (7 ibuprofen every day); Sender's Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of Thrombosis. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified.
53 2021-01-03 heart rate increased After got vaccinated, I walked out of the clinic to monitoring area approximately 15 walking steps, ... Read more
After got vaccinated, I walked out of the clinic to monitoring area approximately 15 walking steps, I felt a little off balance but I was able to make to the chair and sat down. Few seconds later, my heart beat increased faster and faster, my neck turned red. I called for help, they gave me some apple juice to drink and talked to me. About 5 minutes later, my heart beat went back to normal rate and my redness turned back to normal skin color. I only had a little vertigo symptom but I was able to manage myself. About 2 hours later, symptoms disappeared and I was back to my normal health
53 2021-01-03 chest discomfort, lightheadedness, blood pressure increased Employee reports to this writer that within 2 minutes of vaccine recieved she experienced dizziness,... Read more
Employee reports to this writer that within 2 minutes of vaccine recieved she experienced dizziness, felt presyncopal,, facial flushing, throat pressure, had elevated BP, itchy cheeks, nausea, chest pressure. Went to ER where they treated her like she had an anxiety attack. No epi given. Patient consulted with her own private ENT?allergist Dr. the next day who states it sounded like a reaction and prescribed Xyzal
53 2021-01-03 palpitations pounding heart and shakiness within an hour; fatigue, neck pain, muscle aches, low grade temp by 16 ... Read more
pounding heart and shakiness within an hour; fatigue, neck pain, muscle aches, low grade temp by 16 hours after vaccine. Resolved in 5 days.
53 2021-01-04 blood pressure increased Received the COVID vaccine at work in her left deltoid 40 minutes prior to arrival to the ER. Withi... Read more
Received the COVID vaccine at work in her left deltoid 40 minutes prior to arrival to the ER. Within 5 minutes of receiving it, serial blood pressure readings began rising, her arm felt heavy, and she developed an uncontrollable tremor primarily in her left arm with what appears to be generalized shivering. Associated with significant anxiety. She has never had an allergic reaction before. No associated shortness of breath or wheezing. No lip tongue or throat swelling. No pruritus or hives. No nausea or vomiting. She was treated for possible dystonic reaction initially with two doses of Benadryl 25mg IV, then 1mg of IV lorazepam, and finally 125mg solumedrol. Symptoms improved significantly with Benadryl, and then resolved entirely after lorazepam. She was discharged home to complete 4 more days of 50mg prednisone.
53 2021-01-04 chest discomfort Shortness of breath; heaviness in chest; headache; dizziness; nausea; The patient also received firs... Read more
Shortness of breath; heaviness in chest; headache; dizziness; nausea; The patient also received first dose of unspecified other vaccine on the same day of COVID vaccine; This is a spontaneous report from a contactable nurse (patient) reported for herself. A 53-year-old female (not pregnant at the time of vaccination) patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at left arm on 29Dec2020 11:30 at single dose for COVID-19 immunization at a hospital. The patient also received first dose of unspecified other vaccine on the same day of COVID vaccine (29Dec2020) at left arm. The patient's medical history included diabetes type 2, arthritis, known allergies to Shrimp and penicillin. The patient's concomitant medications received within 2 weeks of vaccination included unspecified medications. No other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took lisinopril and experienced drug hypersensitivity (Known allergies: Lisinopril). The patient was not diagnosed with COVID-19 prior to vaccination, and had not been tested for COVID-19 post the vaccination. On 29Dec2020 11:30, the patient experienced shortness of breath, heaviness in chest, headache, dizziness and nausea. Treatment for above events included antihistamine. The outcome of the events shortness of breath, heaviness in chest, headache, dizziness and nausea was recovered in Dec2020. The events were reported as non-serious by the reporter. Information on the lot/batch number has been requested.
53 2021-01-04 chest pain Tingling lips Sore throat Burning in chest Rash Headache Neck stiffness SOB
53 2021-01-04 heart rate increased Very painful shoulder 24 hours later; pounding heart rate felt in my chest that lasted less than 30 ... Read more
Very painful shoulder 24 hours later; pounding heart rate felt in my chest that lasted less than 30 sec; with in 5 minutes of inoculation experienced an odd taste in my mouth; Warm sensation in Left upper arm for at least 15 minutes.; This is a spontaneous report from a contactable other Health Care Professional (HCP). A 53-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 23Dec2020 at 13:15 (at the age of 53-years-old) at an unspecified dose in the left arm for COVID-19 vaccination. Medical history included pneumonia, high cholesterol, eczema rashes from perfumes/beauty products/soaps and hand dermatitis all on unknown dates.The patient is allergic to amoxicillin (rash trunk) and experiences seasonal allergies in the eyes/nose/with coughing. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. The patient was administered the vaccine in the hospital. There were no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Dec2020 at 13:20 (reported as "within 5 minutes of inoculation") the patient experienced an odd taste in her mouth, a pounding heart rate felt in her chest that lasted less than 30 seconds (may have been shorter). She stated that she was trying to stay calm. Also, she experienced a warm sensation in the left upper arm for at least 15 minutes as well as a very painful shoulder twenty-four hours later; there was no swelling nor redness noted. Her shoulder was much improved by the third day.The patient did not receive any treatment for the events. The clinical outcomes of heart rate increased, taste peculiar, localized feeling of warmth and shoulder pain were reported as recovered on an unspecified date in Dec2020. It was also reported that since the vaccination the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
53 2021-01-04 palpitations heart began racing; dizziness/lightheaded; felt foggy; became winded/short of breath; felt an adrena... Read more
heart began racing; dizziness/lightheaded; felt foggy; became winded/short of breath; felt an adrenaline rush; Nasal congestion started after 30 min; within 3 min after injection, became flushed; This is a spontaneous report from a contactable nurse (patient). A 53-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899), via an unspecified route of administration on 19Dec2020 07:30 AM at left arm, at single dose for covid-19 immunization. Medical history included Type 1 diabetes, hx of anaphylaxis to allergy shots and allergies to Latex, avocados, fluorescein dye (anaphylaxis), cats/dogs, environmental. Concomitant medication included ascorbic acid (VIT C), ergocalciferol (VIT D), fexofenadine hydrochloride (ALLEGRA), insulin lispro (HUMALOG), tocopherol (VIT E). The patient was not pregnant at the time of vaccination. Within 3 min after injection, the patient became flushed from 19Dec2020 07:33 AM; heart began racing, dizziness, lightheaded, felt foggy, became winded/short of breath and felt an adrenaline rush, was observed by med personnel x 30min from 19Dec2020 08:00 AM. Nasal congestion started after 30 min on 19Dec2020 08:00 AM. No treatment was received for all events. These events resulted in Doctor or other healthcare professional office/clinic visit. The outcome of the events was recovered in Dec2020. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No seriousness criteria: no Results in death, no Life threatening, no Caused/prolonged hospitalization, no Disabling/Incapacitating, no Congenital anomaly/birth defect.
53 2021-01-05 blood pressure increased, heart rate increased associate states she has hx of allergic reactions to vaccines; i.e flu. patient came in c/o of visi... Read more
associate states she has hx of allergic reactions to vaccines; i.e flu. patient came in c/o of vision problems and numbness to entire body. Benadryl 25mg PO given at 1106. VS: BP 149/122, oxygen 90%, and HR 77 at 11:14 1119: 186/116, HR 79, and oxygen 95%. 1123: 206/102, HR 89, oxygen 96% 1125: EMS called.
53 2021-01-06 palpitations Headache Weakness, Myalgia, Arthralgia, Weakness, Nausea, Palpitations Narrative: Medication and se... Read more
Headache Weakness, Myalgia, Arthralgia, Weakness, Nausea, Palpitations Narrative: Medication and self-care instructions: drink plenty of fluids, take motrin if needed.please return if symptoms worsen or persist.
53 2021-01-06 chest discomfort Injection site pain, tiredness, headache, chills, feverish (masked because of hot flashes), injectio... Read more
Injection site pain, tiredness, headache, chills, feverish (masked because of hot flashes), injection site swelling, injection site redness, nausea, swollen lymph nodes, sneezing, runny nose, dizziness and weakness, and slight chest pressure. Symptoms came and went but the palm sized redness and swelling at the injection site with extreme itching continues to this day. Used cold compresses, topical lotion for allergies, and Vaseline but nothing helped. Will try Benadryl.
53 2021-01-07 fast heart rate After second dose of Pfizer COVID-19 vaccine, patient started "feeling weird" and "washed over". Pat... Read more
After second dose of Pfizer COVID-19 vaccine, patient started "feeling weird" and "washed over". Patient denied dyspnea, nausea, DM/hypoglycemia issues, known heart issues, swelling/itchiness, adverse event with first vaccine, and no adverse event to previous other vaccines. Patient had eaten lunch, but just come off of a shift and thought she might be dehydrated. Water was provided to the patient. Patient stated that she had intermittent lightheadedness/dizziness. Patient denied performance of vasovagal maneuver. Patient also experienced tachycardia and was clammy. Cool pack was provided to patient. Clinical course below: 1530 145/81, 105, 97%, 15 1535 119/81, 88, 96% 1540 126/75, 87, 96% 1542 pt felt another wave of lightheadedness, HR 103 1546 126/79, 90, 96% 1551 128/80, 91, 96% 1555 140/60, 79, 96% 1559 110/84, 87, 97% 1600 pt reports new scratchy throat 1602 25 mg Benadryl administered by RN 1603 discussed with Pharm D 1605 131/77 91, 97% 1611 145/79, 95, 98% Pt finished 12 oz of water and 4 oz of juice 1615 pt reports throat feeling better 1615 118/62, 69, 96% 1630 109/95, 99, 97% Pt stuck out tongue, no evidence of edema 1621 127/72, 84, 97%  At 1642, patient was discharged to family's care and taken home.
53 2021-01-07 palpitations neck pain; fatigue; possible low grade fever; muscle ache; injection site pain; heart pounding and s... Read more
neck pain; fatigue; possible low grade fever; muscle ache; injection site pain; heart pounding and shakiness; heart pounding and shakiness; This is a spontaneous report from a contactable nurse, the patient. A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) solution for injection in the right arm on 29Dec2020 at 14:30 (at the age of 53-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included seasonal allergies and prior Covid diagnosis. Concomitant medications were unknown. The patient had no known allergies. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19. On 30Dec2020 at 06:30, the patient experienced neck pain, fatigue, possible low grade fever, muscle ache, injection site pain within 16 hours of vaccination; heart pounding and shakiness within an hour of vaccination (29Dec2020 15:30). Treatment was provided for the events neck pain, fatigue, possible low grade fever, muscle ache, injection site pain, heart pounding and shakiness included acetaminophen (TYLENOL) and ibuprofen. The outcome of the events neck pain, fatigue, possible low grade fever, muscle ache, injection site pain, heart pounding and shakiness was recovered. Since the vaccination, the patient has not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
53 2021-01-08 hypotension Customer rec'd COVID-19 vaccine at 1208pm and transferred to post vaccine observation. Customer note... Read more
Customer rec'd COVID-19 vaccine at 1208pm and transferred to post vaccine observation. Customer noted to be frequently rubbing her eyes, initially denies feeling any symptoms. Symptoms of itching eyes persistent followed by customer clearing throat repeatedly. Continues to deny symptoms related to vaccine. States that she has anxiety. Customer noted to be hypotensive at 1226 98/68. Refuses epinepherine, transport to ED for monitoring. Customer accepts Benadryl 50mg PO @ 1227. O2 sat ~94-95%, pulse 79-84. Customer monitored at site, escort and significant other, at chairside. Customer persistent with her request to leave throughout observation, states she is fine. Customer and escort counseled to watch for progressive s/sx of reaction including increase in throat symptoms, swelling, itching/rash, SOB, chest pain or any other symptoms that are outside her baseline. Instructed to contact EMS for transport to ED. Customer and escort in agreement with plan. Customer does not have resolution with dry throat symptoms but does not wish to remain in observation any longer. Vitals at 1307 consistent with baseline as documented previously in chart. Customer instructed to contact PCP Team prior to next vaccine appointment to discuss post vaccine course and discuss risks/benefits and/or pre-treatments prior to next vaccine. Customer denies questions/concerns. Escort verbalizes understanding of instruction and agrees to remain with customer for the next 24 hours. Customer released from site at 1315, ambulating independently with steady gait, no obvious s/sx of distress
53 2021-01-08 hypertension HYPERtension Narrative: 0930- Pt complained of not feeling well, VS taken, BP 182/85, HR 92, O2Sat ... Read more
HYPERtension Narrative: 0930- Pt complained of not feeling well, VS taken, BP 182/85, HR 92, O2Sat 100%; Pt was placed on observation. 0944- VS taken again,BP 177/89, HR 94, O2Sat 100% 1000- Pt stated she was feeling better and event was probably due to anxiety; Pt declined going to ED; VS taken again, BP 149/83, HR 85, O2Sat 100%; Pt discharged home.
53 2021-01-10 blood pressure increased, chest discomfort Patient experience chest pressure, increased blood pressure within 10 minutes of receiving COVID vac... Read more
Patient experience chest pressure, increased blood pressure within 10 minutes of receiving COVID vaccine dose #2. H/O Myasthenia gravis and experienced exacerbation of myasthenia gravis.
53 2021-01-10 blood pressure increased, chest discomfort Within 10 minutes of receiving COVID Vaccine dose #2, patient experience chest pressure, increased b... Read more
Within 10 minutes of receiving COVID Vaccine dose #2, patient experience chest pressure, increased blood pressure and exacerbation of myasthenia gravis. Patient has a history of myasthenia gravis.
53 2021-01-10 fast heart rate Woke at 3 am with severe myalgias, tachycardia, nausea and shortness of breath. Went to get tyleno... Read more
Woke at 3 am with severe myalgias, tachycardia, nausea and shortness of breath. Went to get tylenol/ zofran but felt like I was going to vomit. Went into the bathroom and sat down. Woke up on the floor shaking. Not sure how long I was down. According to my watch my HR was around 110+ for a hour and a half (3-4:30 am)
53 2021-01-10 hypertension, heart rate increased, chest discomfort, lightheadedness chest pressure; tightness /pressure in throat; Face red; BP 186/90; within 2 min. of injection had n... Read more
chest pressure; tightness /pressure in throat; Face red; BP 186/90; within 2 min. of injection had near syncope that would come in waves every 2-3 minutes; Headache; rapid HR; Chills; mild cough; Dizziness; fatigue; This is a spontaneous report from a non-contactable health care professional nurse, the patient. A 53-years-old non-pregnant female patient (nurse) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EJ1685), in the right arm on 28DEC2020 08:15 as a single dose, for COVID-19 vaccination. Facility where the most recent COVID-19 vaccine was administered was a Hospital. Medical history included asthma and gastroesophageal reflux disease from an unknown date and unknown if ongoing. Known allergies include Tape, Walnuts, and Cat hair. Concomitant medication received within 2 weeks of vaccination included acyclovir [aciclovir] (ACYCLOVIR [ACICLOVIR]), ferrous gluconate, herbal nos, vitamins nos (FLORADIX), lansoprazole (PREVACID), cholecalciferol (VITAMIN D [COLECALCIFEROL]). No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. On 28DEC2020 08:15 within 2 min. of injection had near syncope that would come in waves every 2-3 minutes, face red, chest pressure, tightness /pressure in throat, headache, BP 186/90, rapid HR. The patient Spent 1 hour in ER. Later in day 28Dec2020, continued to have dizziness, chest pressure, chills, headache, fatigue. This continued for 4 days and had mild cough. The adverse events resulted in an emergency room (ER) visit. and Physician Office Visit. Treatment included Xyzal which relieved majority of symptoms. Laboratory test and procedures on 28Dec2020 include Electrocardiogram (EKG) with normal results, Blood Pressure Measurement 186/90 and Heart Rate Rapid. Treatment was given for chest tightness, throat tightness and red face and No treatment was given for chills, cough, dizziness, fatigue, headache, heart rate increase, blood pressure high and near syncope. The clinical outcome of near syncope that would come in waves every 2-3 minutes, face red, chest pressure, tightness /pressure in throat, headache, BP 186/90, rapid HR, dizziness, chest pressure, chills, headache, fatigue, mild cough was recovered. No follow-up attempts are possible. No further information is expected.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported face red, chest pressure, tightness /pressure in throat, blood pressure increased (BP 186/90), near syncope and the administration of BNT162B2, based on the reasonable temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
53 2021-01-11 lightheadedness A vasovagal response occurred after shot, after sitting for 25 min, I ate lunch. I left facility 1 ... Read more
A vasovagal response occurred after shot, after sitting for 25 min, I ate lunch. I left facility 1 hour later. After 2 hours of the shot, the left arm began to be noticeably sore. 12 hrs post vaccine, I had flu-like symptoms. 24 hrs post vac, flu-like symptoms continued and the injection site had a visibly 2" swollen, red warm circle and raised area; also, I experienced considerable lymph node soreness in left underarm and under jaw (neck area) and itchiness at injection area. 36 hrs post vaccine, the flu-like symptoms subsided, but the injection site continued to grow to 3" red, warm and swollen area. Also I continued to have the itchiness, sore lymph nodes in the left arm (injection arm). Today is 48 hours post vac and I continue to have the red, raised, warm and itchy swollen circle at the injection site with soreness in the lymph node glands on left arm.
53 2021-01-11 loss of consciousness Approximately 5 min after administration are is tingling, then got light headed. Next AM at 0700 wa... Read more
Approximately 5 min after administration are is tingling, then got light headed. Next AM at 0700 was extremely tired. When getting out of bed in AM blacked out and fell to the floor. Was able to get up but head was cloudy all day long. She felt very sore and head hurt all day. The next am had headache.
53 2021-01-11 oxygen saturation decreased Patient developed Tinnitus for 20 minutes immediately after COVID vaccine. Severe joint pain (histor... Read more
Patient developed Tinnitus for 20 minutes immediately after COVID vaccine. Severe joint pain (history Rheumatoid Arthritis) began 4 hours later, and she could barely move hands. She had a severe asthma attack (history asthma) 1 hour later. Breathing has been poor since then with many asthma attacks and oxygen level as low as 79%. Still cannot sleep lying down without oxygen level dropping. Seen at Lung Center 12/31/2020 began tapering prednisone dose beginning at 60mg. Didn't tolerate 40mg so was at 60mg through 1/9/2021. Now decreased to 40 mg and is having increased shortness of breath and more breakthrough nebulizers. 1/4/2021 feeling no better. Given dexamethasone and kept on steroids. Returned to working just at home on 1/11/2021. No history of asthma reaction this severe in past other than post- ablation, but duration then was shorter.
53 2021-01-12 blood pressure increased, chest discomfort 12/23/2020-RECEIVED VACCINE AT 9:52 AM. REPORTS NOT FEELING WELL IN THE AFTERNOON, LIGHTHEADED AND ... Read more
12/23/2020-RECEIVED VACCINE AT 9:52 AM. REPORTS NOT FEELING WELL IN THE AFTERNOON, LIGHTHEADED AND DIZZY, THROBBING HEADACHE. CRAMPING/ACHING IN BACK OF CALVES. 12/24/2020 CONTINUED WITH DIZZINESS, THROBBING HEADACHE, BLOOD PRESSURE ELEVATED, CHEST PRESSURE 8:00 PM REPORTED FEELING THAT SHE WAS GOING TO DIE, WENT TO LAKE CITY MEDICAL CENTER- BLOOD PRESSURE ON ARRIVAL 184/101 HR. 117. GIVEN NITRO AND MEDICATIONS. ADMITTED, DISCHARGED 48 HOURS LATER ON 12/26/2020. DISCHARGED ON BLOOD PRESSURE MEDICATION 12/27/2020-LESS THAN 24 HOURS AFTER BEING DISCHARGED SHE WAS READMITTED TO MEDICAL CENTER WITH SAME SYMPTOMS. 36 HOURS AFTER ADMISSION, TRANSFERRED TO MEDICAL CENTER. FOR CARDIC WORKUP AND HIGHER LEVEL OF CARE.
53 2021-01-12 heart rate increased @0940 patient c/o anxiety, felt like she was having a rapid pulse, v/s 137/91 (her normal is 120s), ... Read more
@0940 patient c/o anxiety, felt like she was having a rapid pulse, v/s 137/91 (her normal is 120s), 95-96% RA, rr 22, hr 84, temp of 97.2, Reports feeling dizzy and light headed. Patient has a history of allergies, swelling. @1004 repeat vitals 123/81y, 98% RA, hr 77, RR 21, denies pain, remains anxious and light headed. About 15 minutes later, she reports feeling better, less anxious, no more light headedness.
53 2021-01-12 blood pressure increased, fast heart rate Experienced intense nausea and dizziness within 25 minutes of injection; tachycardia, increased bloo... Read more
Experienced intense nausea and dizziness within 25 minutes of injection; tachycardia, increased blood pressure; skin redness with blotches on face and neck; uncontrollable shaking; chills. These diminished to tolerable level within 30 minutes after onset. Evening of injection: nausea, vomiting, fatigue, muscle cramping. Next day: nausea, light headedness
53 2021-01-12 fainting Systemic: Fainting-Severe
53 2021-01-14 heart rate increased Nausea; fast heart rate; low grade temp (99.4-100); headache; body aches; soreness at site; This is ... Read more
Nausea; fast heart rate; low grade temp (99.4-100); headache; body aches; soreness at site; This is a spontaneous report from a contactable Nurse (patient herself). A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Dec2020 13:00 (Lot number: EK5730) at SINGLE DOSE (first dose, left arm); and via an unspecified route of administration on 07Jan2021 13:00 (Lot number: EK9231) at SINGLE DOSE (second dose, left arm) for COVID-19 immunization. Medical history included hypertension, high cholesterol, Graves disease, and Known allergies: Sulfa from an unknown date and unknown if ongoing. The patient was not diagnosed with COVID-19 prior vaccination. The patient has not been tested for COVID-19 since vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received the vaccine at hospital. Concomitant medication included hydrochlorothiazide, atorvastatin, amlodipine from unspecified dates for unspecified indications. The patient experienced nausea, fast heart rate, low grade temp (99.4-100), headache, body aches, soreness at site on 08Jan2021 06:00. The patient underwent lab tests and procedures which included temp 99.4-100 and heart rate fast on 08Jan2021. Treatment was not received for adverse events. Event outcome was recovering. The reporter assessed the events as non-serious.
53 2021-01-14 hypertension, fast heart rate shivering; tachycardia; BP 139/89/BP 148/91; Left arm very sore; Left arm tingled; This is a spontan... Read more
shivering; tachycardia; BP 139/89/BP 148/91; Left arm very sore; Left arm tingled; This is a spontaneous report from a contactable healthcare professional reporting for herself. A 53-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on 07Jan2021 10:30 in left arm at single dose for COVID-19 immunization. Medical history included mild hypertension, chronic migraine and recent elevated liver tests - Alk Phos (alkaline phosphatase) & GGT (Gamma-glutamyltransferase) from an unknown date and unknown if ongoing. Concomitant medication included metoprolol succinate 25 mgs daily and colecalciferol (VITAMIN D). On 07Jan2021 21:30, following shot for a few minutes, the patient experienced left arm tingled, had a brief period lasting a few minutes of shivering that evening and tachycardia. Noted at 9:30 pm, patient's BP 139/89, pulse 88 (BP 115/88 and pulse 76 4 days prior). Then BP 148/91, pulse 69 at 10 am on 08Jan2021 after two doses of Metoprolol Succinate ER 25 mgs at 9:45 pm on 07Jan2021 and at 8:30 am on 08Jan2021. The patient experienced left arm very sore on 07Jan2021 after receiving vaccine. Seems to be improving on 08Jan2021. The outcome of the events was not recovered. no treatment was given to the patient for the events. The facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The events were considered non serious as it did not result in death, was not life threatening, did not cause/prolonged hospitalization, was not disabling/Incapacitating and had no congenital anomaly/birth defect.
53 2021-01-15 chest discomfort Patient reported chest tightness (1-2 on 0-10 pain scale) and left arm tingling approximately 10 min... Read more
Patient reported chest tightness (1-2 on 0-10 pain scale) and left arm tingling approximately 10 minutes after receiving the 2nd COVID vaccine dose. Patient reported symptoms felt similar to times when she had exposure to cats or after exercising. She denies any previous treatments for anaphylaxis or any previous severe reactions. Vital signs at time of initial assessment were BP 147/100, pulse 80, O2 Sat 99% on room air. Patient was observed for 50 minutes and chest tightness/arm tingling symptoms resolved. Patient did also develop a dry "tickly" cough about 60 minutes post vaccination. Patient was administered albuterol 2 puffs via MDI and reported improvement of cough. She again reported the cough to be similar to the type of cough she had gotten when exposed to cats. No further treatment needed. Patient stable and released to go home.
53 2021-01-16 fainting, loss of consciousness On 01/01/21, I experienced a vaso vagal syncope episode and actually passed out and injured my upper... Read more
On 01/01/21, I experienced a vaso vagal syncope episode and actually passed out and injured my upper back and right side of rib cage. I am a nurse and was looking up the required reporting and saw this as a reportable event, and even though it indicates within 7 days, I thought it might be worth reporting. I have never passed out like that before.
53 2021-01-16 hypertension Severe abdominal pain, nausea, high BP
53 2021-01-16 loss of consciousness Within 15 mins of the inj. started feel fuzzy, under conscious sedation, warm sensation going up the... Read more
Within 15 mins of the inj. started feel fuzzy, under conscious sedation, warm sensation going up the right arm and neck and right ear. The left arm felt like battery acid, hurt super bad. Felt like an outer body experience. Was given Benadryl. Was having a problem clearing her throat. Felt weird by her bellybutton, felt like she had on a corset on. Rash developed at sternum and bellybutton. Went over to her ER at work. The knee to the hip felt like she had cement on them. Her tongue started to swell. She was wheeled up to tramum2. She blackout at some point. Her body was doing one thing and her mind another. She had EpiPen stat. Right was twitching like Parkinson's. After 1 1/2 she started feeling a little better. 69/43 bp recorded. The next few days she felt like she had Mono.
53 2021-01-18 chest discomfort Developed shortness of breath, chills, diarrhea, abd pain, fatigue, chest pressure, body aches, sore... Read more
Developed shortness of breath, chills, diarrhea, abd pain, fatigue, chest pressure, body aches, sore throat on 1/13/2021. Continues to have sob, chest pressure, abd pain, and fatigue. COVID test neg on 1/17.
53 2021-01-18 fainting I experienced chills, body aches, back pain, dizziness, nausea, dry heaves and passed out. When I pa... Read more
I experienced chills, body aches, back pain, dizziness, nausea, dry heaves and passed out. When I passed out, I bit my lower lip and it bled quite a bit. I had brain fog, and couldn't come up with the correct words. Also, I could not sleep that night, at all without taking a few sleeping pills. It has been a week since this happened and I still can't sleep on my own. I used to be able to go right to sleep without any sleeping pills within about 5 min after laying down at night.
53 2021-01-18 blood pressure increased Pt felt warm and dizzy. Shared had not eaten all day prior to vaccine. Hx of hypertension and bp was... Read more
Pt felt warm and dizzy. Shared had not eaten all day prior to vaccine. Hx of hypertension and bp was elevated. Observed in clinic and given food / gatorade. Pt recovered without incident and released.
53 2021-01-19 heart rate increased ? headache ? muscle pain ? chills ? joint pain nausea swollen lymph nodes (lymphadenopathy) Swellin... Read more
? headache ? muscle pain ? chills ? joint pain nausea swollen lymph nodes (lymphadenopathy) Swelling of your face and throat ? A fast heartbeat ? A bad rash all over your body ? Dizziness and weakness
53 2021-01-20 chest pain C/O Chest pain, fatigue, fever >100.0, the next day, post vaccination. No medical evaluation. Sx's... Read more
C/O Chest pain, fatigue, fever >100.0, the next day, post vaccination. No medical evaluation. Sx's resolved on their own. CG has no ongoing complaints and is currently working
53 2021-01-21 hypertension 30 minutes of vaccine vomiting and blood pressure was high 190/106 then ER and blood pressure every... Read more
30 minutes of vaccine vomiting and blood pressure was high 190/106 then ER and blood pressure every 15 minutes for hour an normal . Prescription Anti Nausea Ondansetron 4 mg
53 2021-01-21 blood pressure decreased, fainting About the 35 minutes later became nausea and threw up, faint and blood pressure 190/106 she was sen... Read more
About the 35 minutes later became nausea and threw up, faint and blood pressure 190/106 she was sent to ER at time of admission blood pressure was going down and back to normal within hour and gave anti- nausea medicine . Blood pressure every :15 for hour 128/76 event resolve . Ondansetron 4 mg Face and chest rash 24 hours later Benadryl 25 mg
53 2021-01-21 hypertension shortness of breath insomnia, high blood pressure, feeling of something logged in my throat,low-grad... Read more
shortness of breath insomnia, high blood pressure, feeling of something logged in my throat,low-grade fever and chills, digestive issues weight loss body aches.
53 2021-01-23 chest discomfort Strong metallic taste in mouth within 2 minutes and lasted about 3 hours, intense left wrist started... Read more
Strong metallic taste in mouth within 2 minutes and lasted about 3 hours, intense left wrist started a prickly tingle about 5 minutes and lasted about 3 hours, mild left palm and arm started a prickly tingle about 10 minutes after injection and lasted 1 hour, started feeling light headed about 10 minutes after and lasted about 1 hour with no blacking out, warm flush feeling started about 5 minutes after the injection and lasted for 32 hours (did not take temperature), my chest felt very heavy and breathing was a little diminished which lasted about 20 minutes. The following morning I felt some nausea with mild dizziness that lasted about 4 hours.
53 2021-01-24 heart rate increased, blood pressure increased 20 mins after the injection, my BP increased to 193/113 ( no h/o HTN), pulse was 134, flushing and a... Read more
20 mins after the injection, my BP increased to 193/113 ( no h/o HTN), pulse was 134, flushing and a rash across my chest, headache, nausea, numbness/tingling in both hands and lightheaded.
53 2021-01-26 palpitations, heart rate increased I was flushed, my arm hurt, palpitations, dizziness, foggy brain, fast heart rate, fever, vomitting,... Read more
I was flushed, my arm hurt, palpitations, dizziness, foggy brain, fast heart rate, fever, vomitting, nausea, headache, stuffiness, congestion, swelling on the arm at the injection site, pain and rash around the injection site.
53 2021-01-26 blood pressure increased, fast heart rate elevated BP : 193/113; Tachycardia 134 BPM; bad headache; numbness and tingling in both hands; numbn... Read more
elevated BP : 193/113; Tachycardia 134 BPM; bad headache; numbness and tingling in both hands; numbness and tingling in both hands; nausea; rash across the top of my chest; sore muscles in legs; This is a spontaneous report from a contactable nurse. A 53-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL1283, via intramuscular route of administration in the left arm, on 12Jan2021 10:30 at SINGLE DOSE for covid-19 immunization. Medical history included asthma, sinusitis and migraine. Concomitant medications included fluticasone propionate, salmeterol xinafoate (ADVAIR), albuterol, estradiol, norethisterone acetate (ESTRADIOL AND NORETHINDRONE), vitamin d3, zinc, paracetamol (TYLENOL) and diphenhydramine hydrochloride (BENADRYL). The patient previously took erythromycin, levaquin, biaxin and cefzil (on unspecified dates) and experienced allergy. The patient started having reactions after 20 mins (12Jan2021, 10:45am): a bad headache, elevated BP: 193/113 (no history of hypertension), tachycardia 134 BPM, numbness and tingling in both hands, nausea, and a rash across the top of the chest. Since it was administered in a workplace drive-thru clinic, there was a 15-30 mins post vaccine monitoring. She was taken inside for further evaluation and monitoring with no changes after 30 mins. EMS was called for transport to the closet hospital that wasn't on diversion. Her allergist was consulted by the treating ER physician and was later discharged with prescriptions for the following: Epipen, prednisone for 5 days, and pepcid. Follow-up with allergist in 3-5 days and PCP. Patient was still recovering however headache was and sore muscles in legs were still present. The outcome of events headache was and sore muscles in legs was not recovered whereas patient was recovering from all other events. Therapeutic measures taken as result of the events included Benadryl, Pepcid, Zofran, Tylenol, 1L Saline bolus, EKG, lab work, monitoring on a pulse ox, frequent BP. No follow-up attempts are possible. No further information is expected. Information on the lot/batch number has been obtained.; Sender's Comments: Based on the compatible time association, the reported events are possibly related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
53 2021-01-27 hypertension Hypertensive and headache after vaccination and sent to ER. Has history of hypertension and takes m... Read more
Hypertensive and headache after vaccination and sent to ER. Has history of hypertension and takes medication or this.
53 2021-01-28 loss of consciousness lost eyesight, everything went black; sweating really bad; cold chills; feels kind of achy; This is ... Read more
lost eyesight, everything went black; sweating really bad; cold chills; feels kind of achy; This is a spontaneous report from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs) received from a contactable consumer. A 53-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL3249), intramuscular in left arm on 14Jan2021 12:00 at a single dose to prevent COVID-19. Medical history included shingles recently and was not given any medicine for that and breast cancer when she was 29 so she can't have shots on her right side. There were no concomitant medications. On 15Jan2021 05:00, she went to the bathroom and everything went black. When her eyesight did come back after a while, she was sweating badly and had the chills. As soon as her husband helped her get back to bed, she started sweating really bed. Her nightclothes were soaked, it wasn't like a normal sweat. She also got the cold chills. She got the cold chills right after she had the experience with her eyesight. She was just kind of achy. However, the sweating, chills, and achiness are all listed on the form she has. She isn't really worried about that. The patient was more concerned about the fact she couldn't see anything. Caller wanted to know if losing her eyesight is a side effect of the vaccine. She confirmed her eyesight came back. The outcome of the event losing her eyesight was recovered while the outcome of the remaining events was unknown. No follow-up attempts are possible. No further information is expected.
53 2021-01-28 chest discomfort, pallor mild fever; chills; anorexia; headache; discomfort in her chest; myalgia/severe muscle pain; leg pai... Read more
mild fever; chills; anorexia; headache; discomfort in her chest; myalgia/severe muscle pain; leg pain; Looked pale; was so hungry; This is a spontaneous report from a contactable physician (patient herself). A 53-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3246, expiry date not reported), via an unspecified route of administration on 13Jan2021 at a single dose for COVID-19 immunization. The patient medical history included that the patient has a severe allergy cold and humidity and therefore before getting the vaccine she took an Advil and loratadine. There were no concomitant medications. The first dose of BNT162B2 for COVID-19 immunization was given on 23Dec2020 (Lot: EL0140) at the age of 53 years old and reported sore arm (added that she cannot move it from the pain) for 24 hours. In regards to the first dose, she only had a severe sore arm and couldn't elevate the arm but this only lasted for 24 hours and then she didn't have any soreness. She received the second dose on 13Jan2021 and experienced mild fever, chills, anorexia, headache, and myalgia. Her supervisor asked her to test positive for covid however she is wondering if she could get a false positive since it is still within 72 hours after vaccination. Patient asked if after vaccination do they not check for antibodies to make sure the vaccine is working. The patient reporting on COVID and who stated she got her second dose on Wednesday (13Jan2021) and who stated she has some questions about side effects and getting tested after vaccination. It was explained that she has had fevers, chills, headache, and discomfort in her chest (Jan2021). She was told to get a test by her job but wondered if she will test positive since it has been less than 72 hours since getting the vaccine. She got the second shot around 7:50pm or 8pm. At midnight she woke up with chills, mild fever, and severe muscle pain. Then she woke up in the morning early with a headache, severe muscle pain, it was very hard to make it. She had severe anorexia, she was so hungry she ate a little and went back to bed. Then she only woke up for lunch and ate something. At that time her fever was gone. She went back to bed but at 8pm she woke up and still had muscle pain. She had a very difficult time yesterday. In the night she woke up with leg pain, muscle pain. The patient explained she felt better today so she went to work and spoke to her supervisor who told her it was better to take a test for COVID. It was mentioned she looked pale and it was better for her to have a test just in case. The patient reported that she knows a bit about vaccines and the proteins and RNA. Since it has been less than 72 hours since she had the second dose, would she test positive if she had a COVID test. No treatment after the doses. Patient states she has no had any testing done at this point. Therapeutic measures were taken as a result of event so hungry. The event fever recovered on an unspecified date in Jan2021. The outcome of the events chills, anorexia, headache, discomfort in her chest and myalgia/muscle pain, leg pain, looked pale, and was so hungry was unknown.
53 2021-01-28 chest discomfort she was 235 pounds, but since getting COVID, she is now 224 pounds; sore arm; feeling her chest tigh... Read more
she was 235 pounds, but since getting COVID, she is now 224 pounds; sore arm; feeling her chest tighten, and congestion; back was hurting; she had lost her taste and smell; she had lost her taste and smell; feeling her chest tighten, and congestion; positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; allergy symptoms; This is a spontaneous report from a Pfizer Sponsored program. A contactable consumer (patient) reported that a 53-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EJ1685), via an unspecified route of administration on 29Dec2020 at a single dose on left arm for COVID-19 immunization as COVID-19 prevention. Medical history included ongoing asthma diagnosed more than three years ago. The patient's concomitant medications were not reported. She had no other vaccines on the same day as her COVID vaccine. The patient had the first dose of the Pfizer COVID vaccine on 29Dec2020, and since then she has contracted COVID, and tested positive for it on 07Jan2021 with symptoms. She asked if she still can get the second shot on the 21st day following her first dose. When she got the vaccine, she was fine, just had a sore arm. A couple days before 07Jan2021, she developed allergy symptoms, and so on the 7th (07Jan2021), she went to get tested, and it was positive. She was 235 pounds, but since getting COVID on Jan2021, she is now 224 pounds. She reported that she started to have allergy like symptoms on maybe 05Jan2021, and on the 7th she went to get tested for COVID, because she had started feeling her chest tighten, and congestion, and her back was hurting, and she has a history of asthma, so she wanted to be seen. She confirmed that on 07Jan2021, she had a Rapid test for COVID, and the results came back the same day, as Positive. She was told that she should also have a 48-hour test, so she had that performed as well, and that one also came back positive, but she knew it would, because by then she had lost her taste and smell. The patient is scheduled for her 2nd dose 19Jan2021. She was wanting to know if she can still get the 2nd dose. She was told she needed to wait 30 days from her positive diagnosis before she could get the 2nd dose. She added that she will still be in isolation when her 2nd dose is due. Outcome of the events was unknown.
53 2021-01-31 heart rate increased 18:52 PM Pt began to feel a rapid heart beat & saw that on the side effect profile on paper. Now s... Read more
18:52 PM Pt began to feel a rapid heart beat & saw that on the side effect profile on paper. Now she feels the same -normal.
53 2021-01-31 blood pressure increased, blood pressure decreased Patient had elevated BP (160/92) at 8:50 am, lower (138/90) at 9:03 am, returned to normal (132/82) ... Read more
Patient had elevated BP (160/92) at 8:50 am, lower (138/90) at 9:03 am, returned to normal (132/82) at 9:16 am.
53 2021-01-31 lightheadedness not feeling good; feeling weak; Chills; hurt like someone hit her; feeling real thirsty; like she wa... Read more
not feeling good; feeling weak; Chills; hurt like someone hit her; feeling real thirsty; like she was going to pass out; Fever; Nausea; tingling on her face; This is a spontaneous report from a contactable consumer (patient). A 53 years old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number EL3248 and Expiration Date Apr2021) via Intramuscular on 14Jan2021 (vaccine location: Left arm) at single dose for COVID-19 immunisation. The patient's ongoing medical history heart murmur and high blood pressure diagnosed about 10 years ago. The concomitant medications was reported as none. Patient was still not feeling good. She said that she had side effects that started on Saturday 16Jan2021. Caller clarified that she had fever, nausea, and tingling on her face. Fever was noticed it on Saturday 16Jan2021 and gone by about 2am on Sunday 17Jan2021. Patient stated that she was feeling real thirsty. Nausea was still there and this morning, patient felt like she was going to pass out. She stated that she had weakness. She stated that she is trying to make an appointment to see her doctor. She stated that the nausea is persisting, but the nausea comes and goes. She stated that yesterday she felt ok, but this morning, she felt nauseated and like she was going to pass out. Patient said that the tingling stopped around 17Jan2021 02:00 along with the fever. Patient stated that she is drinking Gatorade and eating crackers and is staying stay hydrated. She stated that she is at work, but she feels weak. She stated that she had chills and she hurt like someone had hit her. She noticed these symptoms on Saturday 16Jan2021 and stated that this was ongoing and they come and go. The outcome of fever and tingling on her face was recovered on 17Jan2021 02:00. The outcome of not feeling good and feeling real thirsty was unknown. The outcome of other events was not recovered.
53 2021-02-02 chest discomfort Chest tightness; wheezing; wheezing; throat swelling; tongue tingling; lip numbness; This is a spont... Read more
Chest tightness; wheezing; wheezing; throat swelling; tongue tingling; lip numbness; This is a spontaneous report from a contactable nurse (patient). A 53-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3302), via an unspecified route of administration in the left arm on 18Jan2021 17:15 at a single dose for COVID-19 immunization. Medical history included hypertension (HTN) and asthma, both from an unknown date and unknown if ongoing. There were no concomitant medications. Historical vaccine included first dose of PFIZER BIONTECH COVID 19 VACCINE on 28Dec2020 at 01:15 PM (lot number: EL1284) in the left arm for COVID-19 immunization given when the patient was 53 years old. The patient did not receive any other vaccine in four weeks prior to covid vaccine. She had known allergies which were not specified. She was not pregnant. The patient experienced chest tightness, wheezing, throat swelling, tongue tingling and lip numbness, all on 18Jan2021 at 05:45 PM with outcome of recovering. The events resulted to Emergency room/department or urgent care. Treatment received for all events included DECADRON and Benadryl script for Epipen. The patient had no covid prior vaccination. She was tested for covid post vaccination through nasal swab on 20Jan2021 with pending result.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of chest tightness, wheezing, throat swelling, tongue tingling and lip numbness due to temporal relationship. However, the chest tightness, wheezing may possibly be associated with the patient's history of asthma. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including chest x-ray and pulmonary function tests, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
53 2021-02-03 palpitations Developed palpitations with orthostatic Increase in heart rate upon standing; Developed palpitations... Read more
Developed palpitations with orthostatic Increase in heart rate upon standing; Developed palpitations with orthostatic Increase in heart rate upon standing; Concern for postural orthostatic tachycardia/POTs; This is a spontaneous report from a contactable Physician (patient). A 53-year-old female patient (not pregnant) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot number: EL0140, intramuscularly on 21Dec2020 07:30 at single dose in Left arm for COVID-19 immunization in hospital. Medical history was none, no known allergies. Patient didn't have covid prior vaccination. There were no concomitant medications. There were no other vaccines in four weeks and no other medications in two weeks. The patient developed palpitations with orthostatic increase in heart rate upon standing. Concern for postural orthostatic tachycardia/POTs. Adverse events started from 23Dec2020, 07:00 AM and resulted in doctor or other healthcare professional office/clinic visit. No treatment was received for the events. The patient had not recovered from the events. Covid test with nasal swab type post vaccination was performed on 01Jan2021 with negative result.
53 2021-02-04 hypertension Felt very hot after getting vaccine: drinking water> Then tasted metallic taste; BP slightly elevate... Read more
Felt very hot after getting vaccine: drinking water> Then tasted metallic taste; BP slightly elevated 160/90; no other issues.Monitored; hot resolving, metal taste resolving
53 2021-02-04 palpitations She thinks she had a delayed anaphylactic shock she was definitely in shock; hypothermic; her adrena... Read more
She thinks she had a delayed anaphylactic shock she was definitely in shock; hypothermic; her adrenal glands are over compensating, working over load; she was having diarrhea; throwing up; she went from cold to profusely sweating back to having chills; she went from cold to profusely sweating back to having chills; she had no blood to her extremities; severe abdominal cramps; headache; her body is just weak; she was feeling dizzy; Her legs were cramping; her heart was racing fast; her lactic acid was really high; This is a spontaneous report from a contactable Nurse. A 53-years-old female patient receive the first dose of bnt162b2 (BNT162B2; Lot # EL3249) vaccine , via an unspecified route of administration in the right deltoid on 13Jan2021 15:55 at single dose for Covid-19 immunisation . Medical history included hypertonic bladder from an unknown date., drug hypersensitivity from an unknown date , migraine from an unknown date. She had migraines. Concomitant medication included solifenacin succinate (VESICARE), buspirone hydrochloride (BUSPAR), spironolactone (SPIRONOLACTONE). The patient previously took flu vaccine VII, bactrim and experienced drug hypersensitivity. The patient stated she thinks she had a delayed anaphylactic shock she was definitely in shock on an unknown date with outcome of unknown , hypothermic on an unspecified date with outcome of unknown , her adrenal glands are over compensating, working over load on an unspecified date with outcome of unknown , she was having diarrhea on an unspecified date with outcome of not recovered , throwing up on an unspecified date with outcome of unknown , she went from cold to profusely sweating back to having chills on an unspecified date with outcome of unknown , she had no blood to her extremities on an unspecified date with outcome of unknown , severe abdominal cramps on an unspecified date with outcome of unknown , headache on an unspecified date with outcome of not recovered , her lactic acid was really high on 18Jan2021 with outcome of unknown , her body is just weak on an unspecified date with outcome of not recovered , her heart was racing fast on 18Jan2021 with outcome of unknown , she was feeling dizzy on 22Jan2021 with outcome of unknown , her legs were cramping on 19Jan2021 with outcome of unknown. The patient was hospitalized because of the events from 16Jan2021 to 17Jan2021. The patient underwent lab tests and procedures which included blood lactic acid: high on unknown date, chest x-ray: unknown results on unknown date, computerised tomogram: unknown results on 18Jan2021 , electrocardiogram: unknown results on unknown date. The patient was given fluids, Toradol and Xanax to treat the events. Further information has been requested.; Sender's Comments: Based on the available information, contributory role of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) to the onset of reported events cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
53 2021-02-07 heart rate increased Received dose one of vaccine, did not have any initial reaction. Stated usually pre-medicates for va... Read more
Received dose one of vaccine, did not have any initial reaction. Stated usually pre-medicates for vaccines, but did not this time due to recommendation of not doing so with this vaccine. One hour post vaccination, developed cognitive changes- deer in the headlight, unable to think/process information, lasting 4-5 hours. Later that evening, extreme fatigue. Resting respirations labored >20/min lasted most of the night along with chills with no fever x 3days. Dizziness with LOUD ringing in R ear started around 1-2am and lasted one week. Pain in joints/muscles of jaw. Next day both ears were hurting inside (eardrum, middle ear) x1week. HR elevated up to 135 bpm walking to bathroom x 2 days post vaccination. Felt sick/wiped out post vaccine for 3-4 days with no energy with muscle aches/stiffness.
53 2021-02-07 palpitations, heart rate increased body aches; heart palpitations that speeded up to 159/110; heart palpitations that speeded up to 159... Read more
body aches; heart palpitations that speeded up to 159/110; heart palpitations that speeded up to 159/110; chills; This is a spontaneous report from a contactable consumer (patient). This 53-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at left shoulder/deltoid left on 20Jan2021 at single dose for covid-19 immunisation. Medical history included ongoing hypertensive diagnosed four years ago. Concomitant medications the medication that she took for her blood pressure. The patient took first dose Covid 19 vaccine two days ago. She started feeling chills on 20Jan2021 and body aches on 21Jan2021. The patient stated two days ago that she had heart palpitations that speeded up to 159/110 all day on 20Jan2021. She was a hypertensive person and her blood pressure will go up. She was told there would be risks. She wanted to know if she should take the second dose on 10Feb. Wanted to know if something will happen to her if she took it. The chills lasted only two hours. The body aches stopped at 5PM. She had heart palpitations with activity and only lasted for 24 hours. The patient had none while laying down. No treatment was received. Outcome of the event chills was recovered on 20Jan2021, of the events body aches and heart palpitations that speeded up to 159/110 was recovered on 21Jan2021. Information on the lot/batch number has been requested.
53 2021-02-08 heart rate increased her voice is still a little raspy; had a hard time speaking; fibrillation in her heart, and that fel... Read more
her voice is still a little raspy; had a hard time speaking; fibrillation in her heart, and that felt rapid; fatigue/tired; sluggish; nausea; she was not feeling well; Dry throat; injection site pain; This is a spontaneous report from a contactable consumer reporting for self. This 53-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1280) on 24Jan2021 at 0.3 ml single by injection to left upper arm for COVID-19 immunisation (reported as works in assisted living). Medical history and concomitant medications were not reported. The patient received the vaccine on 24Jan2021, Sunday morning, then 6 hours after started feeling injection site pain, it was really sore, but she packed it with ice that night and it was very slight now. She worked the following morning (25Jan2021), and was sluggish, fatigue, and tired. Also nausea (started in the afternoon), it was slight, she was not feeling well. She experienced fibrillation in her heart, and that felt rapid, that comes and goes. Also dry throat on 25Jan2021, not sore, just dry. Her voice was still a little raspy, not like it was yesterday, she had a hard time speaking, when talk and dry throat. The outcome of injection site pain was recovering, sluggish, fatigue/tired, nausea was not recovered, outcome of other events was unknown.
53 2021-02-09 heart rate increased my system felt ramped up; my voice sounded worked up; I had slightly shallow breathing; My heart rat... Read more
my system felt ramped up; my voice sounded worked up; I had slightly shallow breathing; My heart rate went up, not extremely high but and EMT said it felt "racy".; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: RL3249) at left arm on 21Jan2021 12:15 AM at single dose for COVID-19 immunization. Medical history included asthma, allergies to sulfa, dairy, egg, peanuts. Patient is not pregnant. Other medications in two weeks included low dose naltrexone and salbutamol sulfate (ALBUTEROL [SALBUTAMOL SULFATE]) and Herbals. No other vaccine in four weeks. Patient previously took erythromycin and epinephrine and had allergy to them. Within 5 minutes (21Jan2021 12:15 AM), her system felt ramped up. Her heart rate went up, not extremely high but and EMT said it felt "racy". She was told that her voice sounded worked up. she had slightly shallow breathing. It lasted about 30 minutes then began to subside. The next day she felt it somewhat. she was totally normal after 12 hours. She had a sensitivity to epinephrine and the Pfizer dose reaction reminded her of a milder version of the epinephrine reaction. No Covid prior vaccination, no covid tested post vaccination. No treatment received for the events; patient was recovered from the events in 22Jan2021.
53 2021-02-14 heart attack, chest discomfort reddened area with bruising with nodule; reddened area with bruising with nodule; numbness and tingl... Read more
reddened area with bruising with nodule; reddened area with bruising with nodule; numbness and tingling in right thumb; numbness and tingling in right thumb; EKG abnormal; large bruise on right buttock/right thigh/right arm; Chest discomfort; Heart attack; This is a spontaneous report from a contactable nurse (patient). A 53-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the left arm, on 06Jan2021 (at the age of 53-years-old) at a single dose for COVID-19 immunization. The patient had no medical history or concomitant medications. The patient experienced electrocardiogram (EKG) abnormal and large bruise on right buttock/right thigh/right arm on 08Jan2021; numbness and tingling in right thumb on 10Jan2021; reddened area with bruising with nodule on 26Jan2021; chest discomfort and heart attack in Jan2021. The clinical course was reported as follows: Two days later after vaccination, she noticed bruising on various parts of body. The first bruise she noticed on the 08Jan2021. It was probably about 3.5 inches in length 2 inches in width. The patient stated that it did not necessarily have a shape. She had a large bruise on her right buttock. Two days later, she noticed a similar in size bruise on the front of her right thigh. Then a couple days later, she noticed three quarter size bruises on her right arm (two on the inner part of arm, and one on the outer, both on upper arm). The very next day, she developed the same sizing bruise. It was about the same size on her left upper arm. There were no other side effects besides the bruising. There was no itching or redness, no skin, respiratory, or neurological issues. The day before her second dose, on 26Jan2021, she noticed a 4 inch reddened area with a two centimeter nodule inside that bruise. The patient stated that the initial bruises began to heal. They are not as dark as they were. They were reported to have started out red and then turned black and blue. The patient also had numbness and tingling in her right thumb. She was having some chest discomfort after the initial vaccination that is still ongoing. The chest discomfort prompted her to go to urgent care on 08Jan2021, where she had an abnormal EKG on 08Jan2021. The patient was told to follow up with a cardiologist. The patient saw the cardiologist on 25Jan2021, where he did an EKG and ECHO. The EKG was abnormal and ECHO with unknown results on 25Jan2021, but the doctor was unable to determine when the heart attack occurred. The cardiologist also ran labs: a troponin to see if anything was acutely going on, and a D Dimer to evaluate her clotting factors; both were negative on 25Jan2021. The cardiologist recommended a computerised tomogram (CT) scan, which was still scheduled at the time of report. The clinical outcome of large bruise on right buttock/right thigh/right arm, chest discomfort, numbness and tingling in right thumb, and reddened area with bruising with nodule was not recovered and of heart attack and EKG abnormal was unknown. The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of reported events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
53 2021-02-17 hypertension Patient expired 02/06/2021. COD as ruled by Coroner "Hypertensive and Atherosclerotic Cardiovascular... Read more
Patient expired 02/06/2021. COD as ruled by Coroner "Hypertensive and Atherosclerotic Cardiovascular Disease."
53 2021-02-17 fainting Syncope; This is a spontaneous report from a contactable nurse. A 53-year-old female patient receive... Read more
Syncope; This is a spontaneous report from a contactable nurse. A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on the right arm on 15Jan2021 12:00 at a single dose for COVID-19 immunization. Medical history included Crohns disease which is in remission (No immunosuppressants in 5 years) and shellfish sensitivity. The patient is not pregnant. Concomitant medication included duloxetine hydrochloride (CYMBALTA), trazodone, buspirone hydrochloride (BUSPAR), lisdexamfetamine mesilate (VYVANSE) and methylfolate. The patient experienced syncope on 15Jan2021. The event was assessed as serious (medically significant). The outcome of the event was recovering. Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event syncope cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
53 2021-02-21 fainting Syncope; headache; body aches; intermittent fevers with flushing/chills; intermittent fevers with fl... Read more
Syncope; headache; body aches; intermittent fevers with flushing/chills; intermittent fevers with flushing/chills; intermittent fevers with flushing/chills; nausea night of 2nd inj and next day; Severe fatigue; joint pain; I felt very ill; akin to the flu; This is a spontaneous report from a contactable nurse(patient). A 53-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on the left arm on 02Feb2021 11:45 AM at a single dose for COVID-19 immunization. Medical history included Crohns disease which is in remission (No immunosuppressants in 5 years) and shellfish sensitivity. The patient received the first dose of BNT162B2 on 15Jan2021 for covid-19 immunization and experienced syncope. The patient is not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was hospital. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient was not tested for COVID-19. Concomitant medication included duloxetine hydrochloride (CYMBALTA), trazodone, buspirone hydrochloride (BUSPAR), lisdexamfetamine mesilate (VYVANSE) methylfolate and Ma. The patient experienced syncope after injection in Feb2021. A few episodes in 18 hrs, the patient experienced headache, body aches, intermittent fevers with flushing/chills, nausea night of 2nd injection and next day in Feb2021. The patient experienced severe fatigue, joint pain, felt very ill, akin to the flu in Feb2021.No treatment received for the adverse events. The patient underwent lab test included body temperature: intermittent fevers in Feb2021.The outcome of the events was recovering. Information on the lot/batch number has been requested.; Sender's Comments: A contribution from BNT162B2 to the event syncope is possible based on available information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
53 2021-02-21 fast heart rate, palpitations Tachycardia, palpitations, SOB, anxiety before, during and after injection. She did go to ER, sympto... Read more
Tachycardia, palpitations, SOB, anxiety before, during and after injection. She did go to ER, symptoms resolved quickly.
53 2021-02-22 heart rate increased At approximately 9:30 pm, my bpm increased dramatically. I normally have a 70 - 85 bpm and last my ... Read more
At approximately 9:30 pm, my bpm increased dramatically. I normally have a 70 - 85 bpm and last my my heart rate ranged from 120 - 152 while lying in bed. It still is above 100 today.
53 2021-02-22 troponin increased, hypertension, chest discomfort Heart enzymes were elevated; Anaphylactic reaction; Blood pressure was 220/116/ her blood pressure w... Read more
Heart enzymes were elevated; Anaphylactic reaction; Blood pressure was 220/116/ her blood pressure was out of control; dizziness does not allow her to go to work; lingering dizziness; Get a tightening in her chest; Fatigue; Left side of temple toward the crown of head she has pressure on the left side of the body; Left side of temple toward the crown of head she has pressure on the left side of the body; lightheadedness; troponin kept increasing; Inflammation around heart; This is a spontaneous report from two contactable consumers or other non health professional (including patient self, a healthcare worker works with patients with lymphomas, a licensed massage/lymphatic therapist). This 53-years-old female received her 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1283, Expiry Date: 30Apr2021) at 0.3 ml single dose intramuscular injection in left arm on 22Jan2021 10:28 (also reported as 10:38) for Covid-19 vaccination. Medical history was none (also reported as no patient history). Concomitant drug was none (reported as no other products). Family Medical History Relevant to AE(s) was none. Historical vaccine included flu shot in Nov2020 for immunisation. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. No other vaccines given the same day or 4 weeks prior. AE(s) following prior vaccinations was none. Patient never had a reaction to any vaccine or shot before. Patent experienced anaphylactic reaction on 22Jan2021, heart enzymes elevated on 22Jan2021, blood pressure was out of control on 22Jan2021, get a tightening in her chest on an unknown date, lingering dizziness on an unknown date, dizziness did not allow her to go to work on an unknown date, inflammation around heart on 22Jan2021, troponin kept increasing on 22Jan2021, fatigue on an unknown date, lightheadedness on an unknown date, left side of temple toward the crown of head she has pressure on the left side of the body on an unknown date. Seriousness for heart enzymes elevated and anaphylactic reaction was hospitalization from 22Jan2021 to 23Jan2021. The events anaphylactic reaction required a visit to Emergency Room, but not Physician Office. The event clinical course was as follows: patient received her 1st dose of the Pfizer vaccine she had an anaphylactic reaction. She was given 3-4 Epis on site (on 22Jan2021) before being transferred to the ER. In the ambulance, she was administered a 4th EpiPen (on 22Jan2021) before getting to the ER, and then admitted to the cardiac unit on 22Jan2021 for observation. Patient also reported Given 3-4 EpiPens on 22Jan2021 and EpiPen auto-injector was Lack of Effect. No Return Sample Received. When she first started having symptoms, her blood pressure was 128/73. When the symptoms got worse her blood pressure started increasing. Her blood pressure was 220/116, they had to admit her to the cardiac unit because her heart enzymes were elevated and her blood pressure was out of control. Her troponin kept increasing and had inflammation around her heart. Her symptoms of anaphylactic reaction went away that same day, 22Jan2021, at the vaccination from her anaphylactic reaction. Patient was discharged and released from the cardiac unit on that Saturday (23Jan2021 ) around 7:30pm. No one could tell her anything about this since she was still having lingering effects and was getting ready to locate a cardiologist and still has tightness in the chest. She mentioned the dizziness did not allow her to go to work. She experiences it on and off, not consistent but less severe than initially. She still had lingering dizziness and she had to drive for a majority of her day and that was concerning. She said that on the left side she will get a tightening in her chest. She said that no one knows what this means moving forward. Patient was concerned about the severity of the reaction and was still not back to normal. She had never had a reaction to any vaccine or shot before and has been in the military. She needed help, direction since she was still not at the full potential to work. She was still fatigued and has tightness of her chest and those are concerns for her. Patient mentioned a part of the symptoms she also had were lightheadedness and dizziness and that started after the vaccine and it's not as severe, but she still had it. On left side of her temple toward the crown of her head she had pressure on the left side of the body and that was the same side where she received the injection, on that left side. Outcome of anaphylactic reaction was resolved with sequel on 22Jan2021. Outcome of heart enzymes elevated was resolved on 23Jan2021. Outcome of blood pressure was out of control was resolved with sequel on 23Jan2021. Outcome of lingering dizziness was resolving. Outcome of left side of temple toward the crown of head she had pressure on the left side of the body, lightheadedness was not resolved. Outcome of tightness in the chest and fatigue was not resolved. Outcome of inflammation around heart and troponin kept increasing was resolved with sequel on an unknown date. Outcome of the other event was unknown.
53 2021-02-22 chest discomfort Shortly after the vaccine I developed chest tightness and SOB causing me to use my Albuterol Inhaler... Read more
Shortly after the vaccine I developed chest tightness and SOB causing me to use my Albuterol Inhaler. Later that evening I took my reg asthma meds. Sat morning still experiencing the SOB but a bad headache appeared and had some stomach aches as well. 1/9 I spoke with my Allergist who advised to take an additional Singulair and Xyzal meds on top of what I was originally taking already. 1/10 was advised to take and Allergra for the SOB along with my reg meds that evening and by the Tuesday of the next week I was finally able to get my back Asthma balanced out.
53 2021-02-24 palpitations Felt hot, burning sensation across chest, palpitations, dizziness, having sensation of everything... Read more
Felt hot, burning sensation across chest, palpitations, dizziness, having sensation of everything smelling sweet, tingling in hands and feet, hands shaking, slight nausea. Evaluated by EMS. Had not eaten given water and tea. Ate protein bar. Feeling better, symptoms resolved. Discharged home at 9:45am.
53 2021-02-24 chest discomfort Pfizer COVID-19 Vaccine EUA Pt received 1st dose of vaccine on 1/31/21. Afterwards, she developed a... Read more
Pfizer COVID-19 Vaccine EUA Pt received 1st dose of vaccine on 1/31/21. Afterwards, she developed a slight cough and chest pressure. Pressure is worse with deep breathing. Denies chest pain. Denies SOB or wheezing. Pt also had episode of loose stool x 1. States she has had an anaphylactic reaction in past, but it did not feel the same. Pt took diphenhydramine 50 mg PO before receiving her vaccine after consulting her PCP. When pt presented to convenient care, vitals WNL. Pt given methylpredisolone 125 mg IM x 1. Pt prescribed epinephrine 0.3 mg injectable 2-pak kit. Provider recommended pt not receive the 2nd dose of vaccine unless PCP says otherwise. Pt discharged to home. 2/1/21: Pt continued to endorse loose stools, fatigue, and body aches. 2/2/21: Pt's PCP told her not to receive 2nd dose of vaccine.
53 2021-02-26 chest discomfort Patient reports experiencing tightness in chest while at rest within 2 minutes after receiving vacci... Read more
Patient reports experiencing tightness in chest while at rest within 2 minutes after receiving vaccine. Pain persisted, 911 was called. BP of 186/96, SPO2 98, HR 92. Patient sweating, appeared very anxious. EKG negative for ST elevation. Patient transported to hospital.
53 2021-02-27 palpitations Within 2 minutes of receiving the injection, I experienced the following symptoms simultaneously: sk... Read more
Within 2 minutes of receiving the injection, I experienced the following symptoms simultaneously: skin flushed/got hot, hands got numb and tingly, back of and sides of my tongue got thick- felt like it was swelling, got more difficult to breathe, heartbeat started racing, felt light-headed. I sat up in the edge of my seat and almost called for help, however the symptoms subsided within 2-3 minutes and then I was fine. Had a lingering, very minor headache and no other symptoms. I didn't tell anybody and came home and took 1 benadryl just to be safe.
53 2021-02-28 heart rate increased, cardiac arrest First muscle soreness at site of injection, then severe redness at site, cherry electric red and pin... Read more
First muscle soreness at site of injection, then severe redness at site, cherry electric red and pink, severe muscle aches, severe joint aches, severe headache, diarreah, dizzyness, the extreme rapid heart rate of 205 BPM. SEVERE SVT, SUPREVENTRICULAR TACHYCARDIA lasting from 9 p.m. Friday evening through the a.m. until I was transported from Urgent Care via Paramedics to Emergency Hospital. I was given an IV of a Medicine to restart my heart twice. I felt like I was dying.
53 2021-03-04 chest discomfort Shortness of breath, chest tightness. BP 179/111, pulse 103, 97% O2 sat.
53 2021-03-14 deep vein blood clot, fibrin d dimer increased Left femoral DVT
53 2021-03-15 heart attack, blood clot I received my first vaccination on February 11, 2021. On February 17th I was rushed to my local ER ... Read more
I received my first vaccination on February 11, 2021. On February 17th I was rushed to my local ER with a massive heart attack. I was rushed by helicopter to second hospital where I underwent an emergency Heart Catherization. It was discovered that I will need a triple bypass surgery. However, there is a HUGE blood clot that formed in my heart, and further treatment is on hold for now, until the massive clot has safely dissolved.
53 2021-03-16 cerebrovascular accident 12 hours after receiving a shot I woke up from a sleep and when I went to walk her right leg collaps... Read more
12 hours after receiving a shot I woke up from a sleep and when I went to walk her right leg collapsed under her. She hit her head at that point. Her leg remained unable to bear weight and Monday morning we went to the emergency room where they diagnosed her with a stroke. Her right leg is paralyzed and her right side weak.
53 2021-03-16 heart rate increased Immediate onset Rapid heartbeat, headache, nausea, extreme immediate fatigue onset Treatment: Atara... Read more
Immediate onset Rapid heartbeat, headache, nausea, extreme immediate fatigue onset Treatment: Atarax, benadryl, extra strength Tylenol, Hydrochloathiazide
53 2021-03-21 chest discomfort, palpitations c/o dizziness, chest pressure and palpitations after vaccine administration.
53 2021-03-22 platelet count decreased, nosebleed Symptoms began on 3/9. She presented to urgent care on 3/11 with petechial rash on both legs and ar... Read more
Symptoms began on 3/9. She presented to urgent care on 3/11 with petechial rash on both legs and arms, purpuric bruising on bottom lip, and mild nosebleeds x 2 days. Transferred on 3/11 to Hospital for lab work due to suspicion of idiopathic thrombocytopenic purpura, and found to have a platelet count <2. Treated with IVIG from 3/11 to 3/12. Platelets normalized by follow-up testing on 3/18, confirming the diagnosis of ITP.
53 2021-03-24 chest discomfort Pfizer-BioNTech COVID-19 Vaccine EUA 24-48hrs after: injection site pain spread to whole-body muscle... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA 24-48hrs after: injection site pain spread to whole-body muscle & joint pain, tiredness, headache, coughing, sneezing, copious/choking amounts of mucous from nose & throat, nausea, vomiting, diarrhea, lightheaded/dizzy, chills/fever (99.1-99.3F), sweating, chest pressure & back pain on left side from waist to neck, difficulty breathing, severe insomnia. 48-72hrs after: all of the above EXCEPT coughing/sneezing/mucous/vomiting/diarrhea. Soft stools w/loss of bowel control. Growing anxiety due to chest pressure/back pain on left side from waist to neck, difficulty breathing & severe insomnia.
53 2021-03-25 platelet count decreased I had my vaccine on Saturday and on Monday my platlets were at 16. I was almost hospitalized but, af... Read more
I had my vaccine on Saturday and on Monday my platlets were at 16. I was almost hospitalized but, after steroids they improved.
53 2021-03-30 hypotension COVID-19 confirmed by positive COVID-19 test; high levels of histamine; hives on back and chest; sho... Read more
COVID-19 confirmed by positive COVID-19 test; high levels of histamine; hives on back and chest; shortness of breath; blood pressure of 80/50; pneumonia; fever; chills; migraine; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6205, expiry date: unknown), via an unspecified route of administration in the right arm, on 26Feb2021 14:30, as single dose, for covid-19 immunization, at a health department. Medical history included known allergies to latex and egg whites. The patient did not have COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. The patient did not receive other vaccines in 4 weeks. On 26Feb2021 at 17:00, 3 hours after the vaccine, the patient experienced fever, chills and migraine which went on for 4 nights (as reported). On 03Mar2021 (reported as "fifth night"), the patient started to have high levels of histamine, hives on her back and chest and shortness of breath for three days (as reported). In Mar2021 (reported as "by the weekend"), the patient went to urgent care, underwent x-ray of chest, and had pneumonia. In Mar2021 (reported as "Monday"), the patient came back with blood pressure of 80/50 and was sent to the emergency room (ER). It was reported that the events pneumonia, fever, chills, migraine, high levels of histamine, hives on back and chest, shortness of breath and blood pressure of 80/50 required physician office and emergency room visits; treatment for these events included fluids, potassium and antibiotics (unspecified). On 06Mar2021, the patient underwent COVID nasal swab which resulted to positive. The patient recovered from events fever, chills and migraine on 02Mar2021; and from high levels of histamine, hives on her back and chest and shortness of breath on 06Mar2021. The outcome of the events pneumonia, "blood pressure of 80/50" and "COVID-19 confirmed by positive COVID-19 test" was unknown.
53 2021-04-05 haemoglobin decreased I received the first covid vaccine on 1/4/21 and the 2nd on 1/25/21. On Feb 22nd I started having h... Read more
I received the first covid vaccine on 1/4/21 and the 2nd on 1/25/21. On Feb 22nd I started having heavy vaginal bleeding and severe stomach cramps. These continued for 9 days and then I went to the Emergency department because I felt like my HGB was low. They checked it and it was 11.3 and did an abd US that showed my endometrium was thick. They recommended follow up with GYN and a biopsy. I continued to have significant bleeding and cramps until the next week when I called the nurse line and they set me up with a virtual visit with GYN provider. She started me on progesterone and scheduled a hysteroscopy and D & C for the following week. The progesterone slowed the bleeding down but I continued to experience abd cramps. I had the D & C and after getting home started to have heavy bleeding and bad cramps again. The following week I called the GYN provider and she had me come in for another Abd US and checked my HGB which was 9.3. She also checked for infection and other labs which were all within nml range. The pathology from my D & C was neg and the GYN really was not worried that is was anything other than a period but was surprised that it was lasting so long. She gave me TXA and after 5 days on that the bleeding has now stopped but I am still having bad cramps in my lower abd and a lot of bloating. Also having lots of jolting pains in lower abd. I have never had periods that were anything like this and never really had bad cramps like this before.
53 2021-04-08 fibrin d dimer increased, pulmonary embolism 53 yo female with a history of PE 12 years prior after 22 hour flightreceived her first dose of Pfiz... Read more
53 yo female with a history of PE 12 years prior after 22 hour flightreceived her first dose of Pfizer BioNTech vaccine on March 20. She tolerated the vaccine without report of systemic adverse events including headache, fevers, chills, myalgia, malaise or nausea. Eight days later (March 28) she experienced light-headedness and uneasiness reminiscent of her prior PE prompting her to visit the emergency room. Per patient D-Dimer was extremely elevated and PE protocol CT chest with IV contrast diagnosed multiple pulmonary emboli. This time, no immediate precipitating factors were identified. She has normal BMI (23), exercises regularly, is a never-smoker. She was placed on therapeutic lovenox 80mg BID. She indicated that is undergoing a workup for a hypercoagulable state and was told she may have antiphospholipid antibody syndrome, although the data and records to support this evaluation are not available for confirmation by undersigned.
53 2021-04-09 chest discomfort Growing anxiety; Injection site pain; Muscle & joint pain; Muscle & joint pain; Tiredness; Headache;... Read more
Growing anxiety; Injection site pain; Muscle & joint pain; Muscle & joint pain; Tiredness; Headache; Coughing; Sneezing; Copious amount of mucous from nose/throat; Copious amount of mucous from nose/throat; Nausea; Vomiting; Diarrhea; Chills; Lightheaded/dizzy; Fever (99.1-99.3F); Sweating; Chest pressure; Back pain on left side from waist to neck; Difficulty breathing; Severe insomnia; Soft stools with loss of bowel control; Soft stools with loss of bowel control; This is a spontaneous report from a Non-contactable consumer (herself reporting). This 53-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EP7534, Expiry date: Not reported) via an unspecified route of administration in left arm on Mar2021 as a single dose for COVID-19 immunisation. The patient was allergic to mycin,neosporin/bacitracin. The patient's medical history and concomitant medication were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID prior vaccination. After 24 to 48 hours of vaccination the patient experienced injection site pain spread to whole-body muscle & joint pain, tiredness, headache, coughing, sneezing, copious amount of mucous from nose/throat, nausea, vomiting, diarrhea, lightheaded/dizzy, chills/fever (99.1-99.3F)/sweating, chest pressure and back pain on left side from waist to neck, difficulty breathing, severe insomnia. After 48 to 72 hours of vaccination the patient experienced Soft stools with loss of bowel control. Growing anxiety due to chest pressure and back pain on left side from waist to neck, difficulty breathing and severe insomnia and all the above events except coughing, sneezing, mucous, vomiting and diarrhea and the patient was sent to emergency room/department or urgent care and hospitalized for one day. The patient received IV, EKG (electrocardiogram), blood panels, X-ray, Ibuprofen, Ativan (lorazepam) as treatment for the events. The patient underwent unknown COVID test post vaccination in ER (emergency room) which shown negative result. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
53 2021-04-11 chest pain Started cephalexin for a bad foot infection..had taken it in past with zero issues...within 30 minut... Read more
Started cephalexin for a bad foot infection..had taken it in past with zero issues...within 30 minutes had horrible lung on burning clenched up fire, gasping and coughing for breath, hives all over me reaction.
53 2021-04-12 hypertension, pallor Started to have tremors within minutes of shot; observer made me go to EM as said I did;t look good/... Read more
Started to have tremors within minutes of shot; observer made me go to EM as said I did;t look good/was very pale and noted shaking. EMT took BP which was high (I'm typically on lower end of average). Observed me for 45 minutes as BP came down to normal range and asked if wanted to go to hospital. Declined as had appointment later that day with my electrophysiologist at Hospital. As day went on, became increasingly tired and had bouts of uncontrollable shaking. Thought it would wear off so just went home to rest. On 3/31/21, BP was high again, tremors were getting worse, had leg weakness, double vision, brain fog, dropping things, loose stools, felt off. Went to Hospital and was admitted for 3 days. Neurloigst, Dr., said it was due to Covid vacccine and NOT to get the second shot, and the hospital internist agreed (MRI of brain and cervical spine showed no new lesions). Wanted todo heart procedure but they are not my private cardio group so checked myself out and went to Hospital the next day (admitted 4/3-4/5/21)
53 2021-04-17 loss of consciousness passed out; chills; fever; headache; tiredness; Shakes; This is a spontaneous report from a contacta... Read more
passed out; chills; fever; headache; tiredness; Shakes; This is a spontaneous report from a contactable consumer reporting for self. A 53-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 30Mar2021 08:00 (Batch/Lot Number: ER8733) as single dose for covid-19 immunisation. Patient received the first dose, administered in Arm Left on 08Mar2021 09:45 (Batch/Lot Number: EN6205). The patient medical history was not reported. Concomitant medications included sertraline hydrochloride (ZOLOFT) taken for an unspecified indication, start and stop date were not reported; vitamin d3 taken for an unspecified indication, start and stop date were not reported; progesterone taken for an unspecified indication, start and stop date were not reported; iron taken for an unspecified indication, start and stop date were not reported. The patient experienced passed out, chills, shakes, fever, headache, tiredness 30Mar2021 08:30. Outcome of events was recovering. Follow-up attempts are needed. Information on lot/Batch number was obtained.
53 2021-04-17 heart attack the contractions and cramping sensation went trough out her entire chest region and her back (like h... Read more
the contractions and cramping sensation went trough out her entire chest region and her back (like heart attack symptoms); the contractions and cramping sensation went trough out her entire chest region and her back (like heart attack symptoms; in the left arm it was cold and tingling; in the left arm it was cold and tingling; experiencing contractions and cramping in her arm and the left side of her torso in the ribcage area that continued for 24 hours; diarrhea on the weekend; strong cramps in her stomach (stomach flu-like symptoms); This is a spontaneous report from a contactable consumer or other non hcp (patient). A 53-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) dose 1 via an unspecified route of administration in Arm Left on 23Mar2021 (Lot number and Expiry date was not reported) as single dose for covid-19 immunisation. Medical history included ischemic colitis in the past and she thinks that maybe the cramping started triggering it again. The patient's concomitant medications were not reported. On 02Apr2021 strong cramps in her stomach (stomach flu-like symptoms) and on an unspecified date, the patient experienced the contractions and cramping sensation went trough out her entire chest region and her back (like heart attack symptoms), in the left arm it was cold and tingling (vaccination site coldness), (paraesthesia), experiencing contractions and cramping in her arm and the left side of her torso in the ribcage area that continued for 24 hours (muscle spasms) and diarrhoea on the weekend. Her second dose is scheduled on 13Apr2021, she would like to know if there are recommendations for her second dose because she heard that with the second dose the side effects are worse, she would like to know if someone else has reported these symptoms. She would like to know if she should possibly receive the vaccine in her thigh instead of her arm and if that would be helpful. The outcome of the events diarrhoea was recovered on 05Apr2020 and outcome of contractions and cramping sensation went trough out her entire chest region and her back (like heart attack symptoms) was not recovered and rest of the events was unknown. Information on the Lot/Batch number has been requested
53 2021-04-18 loss of consciousness Unconscious; Stood up and became very dizzy; Fell to the floor; Legs and arms were seizing; Legs and... Read more
Unconscious; Stood up and became very dizzy; Fell to the floor; Legs and arms were seizing; Legs and arms were seizing; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW0150), via an unspecified route of administration, on 02Apr2021, at a single dose, for COVID-19 immunization. The patient's medical history included seizures (but they are rare). The patient had unspecified concomitant medications. The patient had no known allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 03Apr2021 at 10:30 AM, the patient stood up and became very dizzy, she fell to the floor and was unconscious. When she came to a few moments after (unknown time), her legs and arms were seizing. The patient did have a history with seizures, but they are rare. No treatment was received for the adverse events. Since the vaccination, the patient has not been tested for COVID-19. The patient was recovering from the events.
53 2021-04-21 chest discomfort Shortness of breath. Chest tightness. Epi given. Albuterol
53 2021-04-24 palpitations Severe headaches; swelling; heavy dizziness; Heart palpitations; heavy body aches and pain; dry mout... Read more
Severe headaches; swelling; heavy dizziness; Heart palpitations; heavy body aches and pain; dry mouth; This is a spontaneous report from a contactable consumer (Patient herself). A 53-year-old female patient received first dose of BNT162B2 (Pfizer COVID-19 Vaccine, Formulation: Solution for injection, Lot number: Unknown, Expiry date: Unknown), via an unspecified route of administration in left arm on 10Apr2021 at 14:15 as single dose for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included diabetes, high cholesterol. There were no known allergies. Concomitant medication included metformin 100 mg, atorvastatin 20 mg and lisinopril for unknown indication. The patient not had COVID prior vaccination. The patient had not taken any other vaccines four weeks prior vaccination. On 10Apr2021 at 14:30 (15-minutes after vaccination), patient experienced severe headaches, swelling, heavy dizziness, heart palpitations, heavy body aches and pain, dry mouth. The patient visited emergency room/ department or urgent care and was hospitalized for the events for one day on unspecified date. The patient was not tested for COVID post vaccination. Therapeutic measures taken as a result of events included intravenous drip, Prednisone. The outcome of all the events was recovering. Information about Lot/Batch number is requested.
53 2021-04-24 loss of consciousness rash covering most of torso; Passed out; unable to hold urine; diarrhea; extremely weak; sweating pr... Read more
rash covering most of torso; Passed out; unable to hold urine; diarrhea; extremely weak; sweating profusely; temp of 101; trembling uncontrollable; freezing; terrible headache; lethargic; This is a spontaneous report from a contactable consumer (who is also the patient). A 53-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8732), via an unspecified route of administration in the left arm, on 07Apr2021 10:30, as single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had no known allergies and was not pregnant at the time of vaccination. The patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6207) received at age 53 years, via an unspecified route of administration in the left arm, on 16Mar2021 11:00, for COVID-19 immunisation. The patient did not receive other vaccines in four weeks. On 08Apr2021 at 03:30, the patient woke up trembling uncontrollable and was freezing. She had a terrible headache. At about 04:30, the patient got out of bed to get some Advil and go to the bathroom. She almost got to the bathroom but was unable to hold her urine and had sudden diarrhea as soon as she sat down. She then became extremely weak and passed out. She was sweating profusely and had a temp of 101. She took Tylenol and Advil and her temp broke an hour or two later. She then had a headache and was lethargic all day on 08Apr2021. On 09Apr2021, the patient felt much better but reported she was still weak, she also had a rash covering most of her torso. Treatment for the events trembling uncontrollable, freezing, terrible headache and temp of 101 included Tylenol and Advil. No treatment was taken for the remaining events. The outcome of extremely weak was not recovered; and the outcome of the remaining events was recovering.
53 2021-04-26 heart rate decreased, lightheadedness, chest discomfort, blood pressure decreased, oxygen saturation decreased This is a spontaneous report from a contactable consumer. A 53-year-old female patient received her... Read more
This is a spontaneous report from a contactable consumer. A 53-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Deltoid Left on 11Apr2021 09:15 (Lot Number: EP7533; Expiration Date: 31Jul2021) as SINGLE DOSE for covid-19 immunisation (Age at vaccination: 53 years). Medical history included asthma, Blood pressure high, acid reflux , allergies: Sulfa, Lactose intolerant and allergies: Latex. The patient's concomitant medications were not reported. The patient had a historical vaccine of Flu shot (INFLUENZA) on an unspecified date for immunisation and experienced bad side effects. The patient previously took bactrim, minocycline, doxycycline, ciprofloxacin, Moxifloxacin, demerol, avelox, nitrofurantoin, naprosyn, motrin, perocet, tramadol and aleve and experienced allergies. The patient experienced anaphylaxis on 11Apr2021. It was also reported that she had an appointment for COVID Vaccine at 9:15AM. Received COVID Vaccine and was told to wait for 30 minutes. Within 10 minutes her chest starting getting tight with difficulty of breathing. Her throat was closing up, and she was light headed. She explained this to the administrator who asked if caller could get up to see the paramedic. As caller tried to stand up, she almost passed out. Had to sit there for a second and the second time was able to get up and made it in to the room. Was going in and out of consciousness. Had to stab her with an Epi Pen. She couldn't breathe. Her throat was closing up. Her tongue was swollen. She was in and out of consciousness. First Epi Pen didn't work. An IV was put in and was given something through it. She was jabbed with a second Epi Pen. Was still in and out of consciousness but she was starting to come back. Was given oxygen and a nebulizer. She does have asthma. Ambulance was called. Was told she was worked on for 20 minutes. When ambulance arrived she was able to get up and get on the cart. She was taken to the hospital. Was given medicine through her IV. Had to be kept at hospital because she had two Epi Pens and medication at the vaccine facility. Hospital wanted to make sure when the Epi Pens wore off she didn't go back into anaphylaxis. Was kept in ER for over four hours. Was given IV fluids. Her oxygen, heart rate, and blood pressure dropped at vaccination facility. Oxygen was 81. Blood pressure was 94. At hospital, her levels started to get better. Once she was given the second Epi Pen and whatever else she was given, the medication started to work and she had come through. At the hospital, someone came in and did bloodwork for research to see why this happened. Was prescribed Epi Pens by the doctor in the hospital and was advised to carry Epi Pens with her at all times. If she has another anaphylaxis, was advised to jab herself with Epi Pen and call right away. Was told her tongue was swelling. Attempted to obtain the outcome of the anaphylaxis. At the hospital, she was so out of breath walking to the bathroom. Was told at hospital now she is having side effects from the COVID Vaccine including the tiredness and headache she is experiences. Was told to take Tylenol and Benadryl, lay down and rest, and to make sure she drinks so she does not get dehydrated. Today, she feels nauseous, lightheaded and tired with a little headache. She feels better from yesterday. Is getting better and is having a little chills maybe an hour ago. She checked her temperature and does not have a temperature, but her insides feel warm . The patient was hospitalized for the event anaphylaxis on an unspecified date. Therapeutic measures were taken as a result of was going in and out of consciousness. Events for anaphylaxis, consciousness fluctuating, chest discomfort. dyspnea, throat tightness, presyncope and swollen tongue occurred on 11Apr2021 while the remaining events occurred on an unspecified date. The patient underwent lab tests and procedures which included blood pressure: dropped and 94, blood work: unknown results, heart rate: dropped, oxygen saturation: 81 and dropped on an unspecified date. Therapeutic measures were taken as a result of all the events. Outcome of the events was unknown.
53 2021-04-26 loss of consciousness, fainting pass out; Vasovagal syncope; passed out again; This is a spontaneous report from a contactable consu... Read more
pass out; Vasovagal syncope; passed out again; This is a spontaneous report from a contactable consumer (Patient). A 53-year-old female patient (Non-pregnant) received second dose of BNT162B2 (Pfizer Covid-19 vaccine, Lot number ER8729 expiry date: unknown) via an unspecified route of administration at right arm as a single dose on 09Apr2021 03:00 PM, for Covid-19 immunization. Medical history included Hypothyroid, She had known allergies to Anti-Inflammatory, aspirin, penicillin, codein, ginger and horse radish. Concomitant medications were not reported. The patient received first dose of BNT162B2 (Pfizer Covid-19 vaccine, Lot number: EP7534 expiry date: unknown) via an unspecified route of administration at right arm as a single dose on 19Mar2021 04:00 PM, for Covid-19 immunization. On 10Apr2021 at 03:00 am, she woke to go to the bathroom feeling fine, after getting up from the toilet she saw stars and felt and had a Vasovagal syncope. When she woke up, she tried to get and pass out again. She woke up and was able to walk to my bed and passed out again when she reached the bed. She did not receive treatment for the events. She did not have any other vaccine in four weeks prior to suspect. She did not have Covid prior vaccination nor was she tested for Covid post vaccination. The patient had recovered from the events of pass out, vasovagal syncope and passed out again. No further information was available.
53 2021-04-28 cardiac arrest cardiac arrest; on the ground turning purple and lifeless/ immediate risk of death from the event; s... Read more
cardiac arrest; on the ground turning purple and lifeless/ immediate risk of death from the event; she had no pulse; on the ground turning purple and lifeless; This is a spontaneous report received from a contactable consumer. A 53-year-old female patient (reporter's mother) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6200), administered in left arm on 24Feb2021 (at the age of 53-year-old) at single dose for COVID-19 immunisation. The vaccination facility type was reported as other. The patient was not pregnant. The patient's medical history was reported as none. No known allergies were reported. The patient had not had COVID prior vaccination. The patient's concomitant medications were not reported. No other vaccine was administered in four weeks. It was reported that on 13Mar2021 08:15 exactly 17 days after reporter's mother received her first Pfizer vaccine she had a cardiac arrest, luckily reporter was with her when this happened and he/she called immediately and followed the steps of cardiopulmonary resuscitation (CPR) etc. When the emergency team arrived she had no pulse and they used the defibrillator on her 4 times. The entire day they did not know if she would survive. She was sedated and tested, they got the news that she had survived and there was not brain damage. The doctors had no clue what the cardiac arrest was caused by, she had no prior health conditions and the tests show nothing to what could have caused this event (no blood clots, no clogged arteries etc.). The only thing that changed leading up to the event was her receiving her first vaccine. Luckily reporter was there when this happened or else she would in fact be dead. She now had a defibrillator implanted and reporter had a post-traumatic stress from the traumatic event and witnessing his/her mom on the ground turning purple and lifeless. They need answers. The events resulted in emergency room/department or urgent care. The events were reported as serious since resulted in hospitalization and life-threatening illness (immediate risk of death from the event). Treatments were received for the events and they were reported as multiple lifesaving treatments, tests, and defibrillator implant. The patient underwent lab tests and procedure which included COVID test (negative) on unspecified date post vaccination. The outcome of the events was resolved for the event "she had no pulse" and resolved with sequel (reported as recovered with lasting effects) for all other events.
54 2020-12-31 hypotension Hypotension noticed 24 hours post injection. Effect lasted for 48-72 hours while improving. Lowest... Read more
Hypotension noticed 24 hours post injection. Effect lasted for 48-72 hours while improving. Lowest BP 85/60, with symptoms: lightheaded at rest.
54 2021-01-03 blood pressure increased 12/31/20 - cough, sneezing, weakness. Felt ill all weekend. 1/3/21 - called Employee Health with lo... Read more
12/31/20 - cough, sneezing, weakness. Felt ill all weekend. 1/3/21 - called Employee Health with low-grade fever, chills, nausea, weakness and elevated blood pressure 165/104, which had come down by the afternoon to 155/95
54 2021-01-04 chest discomfort About 49 hours after receiving the Pfizer mRNA COVID-19 vaccine, patient developed chest tightness, ... Read more
About 49 hours after receiving the Pfizer mRNA COVID-19 vaccine, patient developed chest tightness, itchy throat, upper and lower eyelid swelling, lip swelling, difficult swallowing. Selt-treated with prednisone 40mg, fexofenadine 1 tablet, famotidine 40mg, albuterol breathing treatment. Felt better, but then 6-8 hours later, felt chest tightness again that did not resolve with breathing treatment. Went to the Hospital Emergency Department. No epinephrine was administered. But received IV corticosteroids, diphenhydramine and famotidine, and was discharged with 6 days of oral corticosteroids
54 2021-01-04 blood pressure increased Fever began on 24th around 10 with chills. Took Tylenol for low grade fever about 12:30 pm. Subsided... Read more
Fever began on 24th around 10 with chills. Took Tylenol for low grade fever about 12:30 pm. Subsided for 6 hours and then 6:30 that evening it returned at 100.7. Again 6 hours later, fever was 100.4. Christmas day, still had fever around 100. Then again that afternoon. Lymph node swelling underneath the arm. The site of the injection I had a large knot. Very swollen, small bruise, hot, and red. No streaking or red lines. Lymph node underneath the arm was about the size of a ping pong. I did not want to go to the ER. I called the nurse line and was triaged over the phone. I was instructed to take BP and pulse and gave numbers over the phone. BP was a little elevated, but nothing to extreme. I pretty much stayed laying down. It sucked the life out of me. I used hot compress and cold compress on site of the injection. It was late Saturday evening when I decided to see a change in the size of the lymph node. By Sunday, the 27th, there was no fever. Not even on Saturday. By Sunday, the lymph node had subsided as well. I did get a headache, but it was like a nagging headache. My left shoulder in the muscle area towards the neck area, I had soreness.
54 2021-01-04 heart rate increased she could not stop shaking; Resting heart rate went to 130; Chills; Headache; Running Temperature/Sh... Read more
she could not stop shaking; Resting heart rate went to 130; Chills; Headache; Running Temperature/She just took it now and it is 100.4 degrees Fahrenheit; Nausea; Feeling unwell; This is a spontaneous report from a contactable consumer reporting for herself. A 54-y ears-old female patient received bnt162b2 (BNT162B2) vaccine, intramuscular in the right arm on 23Dec2020 07:00 at single dose for covid-19 immunisation . Medical history included covid-19 from Jul2020 to an unknown date. There were no concomitant medications. The patient experienced chills on 24Dec2020 with outcome of recovering , nausea on 23Dec2020 23:00 with outcome of recovering , headache on 24Dec2020 with outcome of recovering , running temperature at 100.4 degrees Fahrenheit on 24Dec2020 with outcome of not recovered , feeling unwell on 23Dec2020 with outcome of not recovered , resting heart rate went to 130 on 24Dec2020 with outcome of recovering , she could not stop shaking on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included body temperature: 99.8 Fahrenheit; 99.2 Fahrenheit, 100.4 Fahrenheit, heart rate: 130 (66-72. Normally) , sars-cov-2 test: negative on 21Dec2020 , sars-cov-2 test: negative on 24Dec2020 . Information on the lot/batch number has been requested.
54 2021-01-05 chest discomfort 20 minutes after receiving the vaccine, patient felt her lips swelling. She then noticed facial swel... Read more
20 minutes after receiving the vaccine, patient felt her lips swelling. She then noticed facial swelling and chest tightness. She then developed erythema to her chest area. She immediately was evaluated. Denies any SOB or difficulty breathing. Denies any itching or hives.
54 2021-01-05 heart rate increased About 30 to 40 mins after receiving vaccine i began to experience acute rapid heart beat, extreme he... Read more
About 30 to 40 mins after receiving vaccine i began to experience acute rapid heart beat, extreme heat or hot flash, shaking, almost hyperventilating but was able to control breathing. Episode lasted 10 mins Immediately with vaccine I noted an antiseptic taste in my mouth and this continues.
54 2021-01-05 chest pain LEFT SIDED CHEST PAIN, SHORTNESS OF BREATH, FELT WARM AND FLUSHED
54 2021-01-06 chest discomfort Subject received vaccine at 0845 in 1/6. Felt chest tightness, cough wheezing 15-20 min later. Took ... Read more
Subject received vaccine at 0845 in 1/6. Felt chest tightness, cough wheezing 15-20 min later. Took personal albuterol inhaler and waited in car 50 minutes Reported to employee health office Sent to ED for SOB, wheezy, tingling in tongue per MD note. (arrived 0958) Nebulizer administered. Chext X-ray negative for acute disease. ED MD states: Asthma exacerbation Left 1143
54 2021-01-06 fast heart rate, palpitations Sxs 90 minutes post vax. SOB, palpatations, nausea, tachycardia. Presented to ED. CXR/EKG normal, l... Read more
Sxs 90 minutes post vax. SOB, palpatations, nausea, tachycardia. Presented to ED. CXR/EKG normal, labs normal, given Zofran inj.
54 2021-01-06 blood pressure increased her face started to go numb/felt like a dental block you would get with Lidocaine; She got on her le... Read more
her face started to go numb/felt like a dental block you would get with Lidocaine; She got on her left side, a cold spike feeling up her shoulder and neck and up to her face; upper esophageal sphincter got tight and felt funny like she was going to throw up; her whole body was shaking- her head, hands, and legs; feeling giddy; blood pressure was up; being stressed; was going to throw up/transient nausea; felt a little funny; This is a spontaneous report from a contactable Nurse(patient). A 54-year-old female patient received BNT162B2 (lot number EL0140), via an unspecified route of administration at left deltoid on 30Dec2020 14:28 at the 54 years old at 0.3 mL single for where she works she was exposed to patients who need rehab that were exposed and getting COVID. The patient medical history included Primary Essential Tremors and ongoing (had these for about 10-11 years. Her mother and grandmother also had them. Normally they were very fine, small tremors that people didn't notice. She can hold and turn her head and hide it) and Sulfa drug allergy (would get shortness of breath). The concomitant product was none. The patient previously took flu vaccine and experienced preservative made neck twitch and joint sores. Yesterday the patient got the COVID Vaccine and had a pretty significant adverse event. She was calling to report it and to see if she should get the second dose of the vaccine. The patient was also a licensed speech pathologist. She received the vaccine yesterday at 2:28 PM. She was allergic to Sulfa drugs and would get shortness of breath, so they wanted her to wait 30 minutes for monitoring. She was feeling giddy on 30Dec2020, but she ran into a friend that she had not seen before quarantine, so they were talking. It was exciting. After her 30 minutes she went to her car and felt a little funny. She thought she was hungry so she ate half a banana and had some water. She had an appointment to get to so she started to drive off, and by the time she got to the interstate she was feeling funny. She got on her left side, a cold spike feeling up her shoulder and neck and up to her face on 30Dec2020. This was like the precursor. Then on 30Dec2020 her face started to go numb. It felt like a dental block you would get with Lidocaine. It went from her temple area, below her eye all the way to her lips. It was midline on the left side. She was breathing fine. She was trying to figure out if she should pull over or call(Number), but her airway did not close up. Her upper esophageal sphincter got tight and felt funny like she was going to throw up. She drove to the hospital close to her house which is affiliated with where she got the vaccine. She normally had primary tremors, small to where people do not notice. But her whole body was shaking- her head, hands, and legs on 30Dec2020. She looked like a bobble head. But she could still breath. They took her right in and they did an EKG to make sure it was not her heart. Her blood pressure was up on 30Dec2020, she assumes for being stressed. They monitored her. They gave her Pepcid and Benadryl. She did not want any nausea medications. She stayed for about 2 hours and slept some from the Benadryl. Her face slowly became less numb. The numbness went away started from her lips and outward to her check and temple area. Then it just felt funny. When she touched it, which she never lost sensation, it was like, whose face is this? It was strange. She is not numb anymore. It took a while for it to go away, and it still felt weird. When she woke up this morning it was completely gone. She had recovered completely from all of these things. The only thing she has now was some transient nausea. It was very mild. It comes and goes. It had improved. She had not taken anything for it. The events Feeling funny, her face started to go numb, upper esophageal sphincter got tight, a cold spike feeling up her shoulder and neck and up to her face, Her whole body was shaking- her head, hands, and legs, were all assessed as Medically significant. The outcome of the event Nausea was recovering, the events Felt giddy, blood pressure was up, Stress was recovered on 31Dec2020, the other events were recovered on 30Dec2020. The reporter considered there was a reasonable possibility that the events Feeling funny, a cold spike feeling up her shoulder and neck and up to her face, Face started to go numb from her temple area, below her eye all the way to her lips, upper esophageal sphincter got tight , whole body was shaking- her head, hands, and legs, Nausea, were related to the product BNT162B2.; Sender's Comments: Based on the compatible temporal association, the vaccination with BNT162B2 might play a contributory role in triggering the onset of the events. The impacts of this report on the benefit/risk profile of the product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
54 2021-01-07 palpitations About 25 minutes after receiving the shot patient became dizzy, jittery and had some palpitations. ... Read more
About 25 minutes after receiving the shot patient became dizzy, jittery and had some palpitations. She was in the parking garage and called 911. She was taken to ED and treated with IV fluids. Her potassium was low and was replaced. Felt better after fluids and was discharged
54 2021-01-07 palpitations At night I felt fatigue and palpitations and could not sleep. Next morning the palpitations and fati... Read more
At night I felt fatigue and palpitations and could not sleep. Next morning the palpitations and fatigue went away but I start with a rash and very itchy and noticed my face swelling up. I took some prednisone I had home and Benadryl and went to the ER. They monitored me and medicated me and told me to keep with the Benadryl. On the 24th I started with the rash and on the 26th no more rash. My second dose is scheduled on the 13th and I will see my PCP on the 12th to decide if I should have the second dose. I am not allergic to anything and thought I would die on 12/24. I was swelling up in less than a minute after I woke up it was awful. I also have a consultation with an allergist on Tuesday before the vaccine.
54 2021-01-07 fast heart rate Headache, Myalgia, Fever, Diarrhea, NauseaVomiting & Tachycardia Narrative: Vaccine received on 12-1... Read more
Headache, Myalgia, Fever, Diarrhea, NauseaVomiting & Tachycardia Narrative: Vaccine received on 12-19-20. Symptom onset several hours later, needed to miss work on Monday 12-21-20 on account of symptoms. No immediate medical intervention required. Self-managed with tylenol.
54 2021-01-07 blood pressure increased, palpitations Shortly after receiving the vaccine, the patient felt like her throat was swollen and her heart was ... Read more
Shortly after receiving the vaccine, the patient felt like her throat was swollen and her heart was racing. Her blood pressure was taken in the observation area, and it was elevated. She was monitored in the observation area, and then she was escorted to the Emergency Department for continued observation. Reaction resolved with no treatment while she was in the Emergency Department and she was discharged. She was instructed to follow up with her allergist.
54 2021-01-07 fast heart rate, chest discomfort first day of vaccine, developed a runny nose (Wednesday, Jan 6) second day, felt fatigued third day,... Read more
first day of vaccine, developed a runny nose (Wednesday, Jan 6) second day, felt fatigued third day, felt lungs were burning and chest heaviness, tachycardia ~ 90's (today) went to an urgent care at work place tonight, lungs clear
54 2021-01-09 chest pain, blood pressure increased Patient received 2nd dose of covid vaccine 1/9/2020 around 1100. Report having mild reaction (flu-l... Read more
Patient received 2nd dose of covid vaccine 1/9/2020 around 1100. Report having mild reaction (flu-like sx) with first dose. She began experiencing feeling like she was outside of her body about 10 min after receiving her booster. BP was taken and was slightly elevated 140s/90s. Ice packs were provided for hot flashes. Warm blankets provided for chills. BP was trending up to SBP 160s then started to decline to normal. Patient was accompanied to restroom by clinic staff and was able to walk without incident. Patient was observed in covid clinic for total of 2 hours and reassured that she was not likely to have worsening of sx at this point. Patient was walked to mother's car by clinic staff and left feeling better. 1/10 - patient presented to ED with low grade fever (100.4), chest pain, severe joint and muscle pain, nausea and "fog brain." She reports BP being 187/101 in ED. Given 1L of normal saline, zofran, toradol, and dilaudid. Observed until BP drcreased to SBP 140s. Nausea improved enough to allow her to eat. Labs were WNL, CK normal. Discharged home with diagnosis of "adverse effect of COVID-19 vaccine"
54 2021-01-10 blood pressure decreased "1/10/21 I go the 2nd shot. My blood pressure dropped and they had to lay me down. It went to 90/40... Read more
"1/10/21 I go the 2nd shot. My blood pressure dropped and they had to lay me down. It went to 90/40, I broke out in a rash on my neck, I am achey all over today 1/11/21"
54 2021-01-10 palpitations, loss of consciousness 30 min after vaccine she became hot, flush, dizzy, heart pounding, hands face and feet were numb and... Read more
30 min after vaccine she became hot, flush, dizzy, heart pounding, hands face and feet were numb and tingly, she passed out at her desk and was taking to the ER for evaluation. Benadryl & Solumedrol Admin with hydration with NS. Pt discharged from ER. Pt in ~10am discharged from ER ~2hrs later.
54 2021-01-10 chest pain Pt received second dose of Pfizer COVID vaccine and felt fine. About 10-15 minutes later she descri... Read more
Pt received second dose of Pfizer COVID vaccine and felt fine. About 10-15 minutes later she described arm pain that radiated up to her left jaw and chest. At this time we recommended she be escorted to the Emergency Department for assessment. This was completed and she was later released home without any longstanding concerns.
54 2021-01-10 chest pain Shortness of breath, Fatigue, muscle aches, chest pain, dizzy and light headed, headache
54 2021-01-10 palpitations Within minutes I became flush and very hot. My heart starting racing. I had blood pressure check an... Read more
Within minutes I became flush and very hot. My heart starting racing. I had blood pressure check and heart rate.
54 2021-01-11 heart rate increased, pallor 9 min post injection pt felt her heart rate increase, was pale and diaphoretic. Vitals signs were t... Read more
9 min post injection pt felt her heart rate increase, was pale and diaphoretic. Vitals signs were taken with BP being 183/113, HR 103 and respirations 22. Pt was sat down, given cool water and apple juice. She reported having not eaten much for the day. Her symptoms began to subside within 10 min and she required no further intervention. She was observed for a total of about 1 hr post injection . Her BP was 136/ 98, HR 83 and respirations 17 when she left for home with her husband.
54 2021-01-11 blood pressure increased Approximately 2 hours after the vaccine, I had flushing feeling, no elevated temperature. Arm soren... Read more
Approximately 2 hours after the vaccine, I had flushing feeling, no elevated temperature. Arm soreness, nausea. I also checked my b/p. It was more elevated than usual. (130/90?s). These symptoms subsided 24-48 hours after the vaccine.
54 2021-01-12 loss of consciousness 14 hours after vaccination, woke up to slight body aches so went to take Tylenol and sudden wave of ... Read more
14 hours after vaccination, woke up to slight body aches so went to take Tylenol and sudden wave of nausea hit and passed out falling on floor. Had slight stomach upset and significant chills. Took Tylenol and was recovered by 8 a.m.
54 2021-01-12 chest discomfort I woke up the next morning with no voice, chest tightness and a mild cough, The 24th, my throat was ... Read more
I woke up the next morning with no voice, chest tightness and a mild cough, The 24th, my throat was worse, the chest tightness was worse and definately had a cough. I self isolated over christmas. My ribs were sore from the coughing. I was screened for FLU & COVID on the 28th before I could return to work. I was treated for bronchitis. I was given cough syrup and an antibiotic.
54 2021-01-13 chest discomfort About 15-20 minutes after vaccination, the patient began to feel chest heaviness and chest tightness... Read more
About 15-20 minutes after vaccination, the patient began to feel chest heaviness and chest tightness. She then felt like she had postnasal drip and her throat began to feel like it was closing. She was short of breath until Epi pen was administered. She did not notice any swelling.
54 2021-01-13 fainting Developed sweating and chills with headache around 3:00 am. Got up at my usual time 5:30 am to use t... Read more
Developed sweating and chills with headache around 3:00 am. Got up at my usual time 5:30 am to use the bathroom and get dressed but felt nauseous with headache. Went to wash my hands and then walked back to bedroom but had syncopal episode along the way lacerating my lower lip and injuring my knees. Still unable to extend knee due to injury with pain and swelling
54 2021-01-13 chest pain, heart rate increased She was wiped out the next day with aches and pains still.; tired; brain fog; started to get cold; s... Read more
She was wiped out the next day with aches and pains still.; tired; brain fog; started to get cold; shake/her hands were shaking so hard; they took her temperature and it was 100/her fever went to 101/temperature had gone to 102.6; heart rate was elevated at 100/heart rate was 110/heart rate went to the high 120s; headache; backache; nauseated; chest was hurting; The initial case was missing the following minimum criteria: Invalid for unspecified adverse event. Upon receipt of follow-up information on 08Jan2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable nurse (patient). A 54-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EK5730), via an unspecified route of administration in deltoid left on 29Dec2020 07:30 at single dose for COVID-19 immunisation. Medical history included ongoing sleep apnoea (diagnosed about 3-4 years ago, wear her CPAP religiously), Hashimoto's hypothyroid, and chronic low vitamin d (lack of sunlight). Concomitant medication included levothyroxine sodium (SYNTHROID) from 2016 and ongoing for Hashimoto's hypothyroid, ergocalciferol (VIT D) from 2018 for chronic low vitamin d; lack of sunlight (She did not take it religiously, but was supposed to take it everyday). At 10:30 AM (29Dec2020), she started to get cold and shake. She thought that this was insane and it was in her head. It became so severe she could not use her computer her hands were shaking so hard. She went back up to where they were giving vaccines, they took her temperature and it was 100. It had been normal the morning before she got the vaccine. Her heart rate was elevated at 100. They put a blanket on her and said they wanted to watch her for 15 minutes. In that time her fever went to 101 and her heart rate was 110. They took her to the ER. She was there for 5 hours. Her heart rate went to the high 120s. They did a 12 lead EKG. Her temperature had gone to 102.6, which was the highest. They gave her a liter of Normal Saline. She also had a headache, backache, and felt nauseated. The liter of fluid helped, no doubt. She was not admitted. She was wiped out the next day (30Dec2020) with aches and pains still. Their concern was they said they did not give her epinephrine because her heart was too high. She had no breathing issues. Just extreme cold. At one point she had woke up in the ER (29 or 30Dec2020) and her chest was hurting, she knows from her heart rate being too fast. She was so cold. She had on 6 blankets. The next day (30Dec2020) she still had the aches and pains, she was tired, and had brain fog. It all went away on 30Dec2020. She had nothing after that. What scared her was the heart rhythm. The ER doctor says its not great, but felt that getting the second dose was better than her having COVID. The Electrophysiologist she saw, said she was unsure if she should get the second dose. The hospital said that for this next dose, they would give her the injection, wait 15 minutes, then send her home, expecting that she would have the same thing happen. When after the first dose, she was in the ER on a 12 lead EKG with an intravenous (IV). She had no arm pain the whole time. The reporter assessed all events related. She felt fine prior, walking in to get the vaccine. But she was much better the next day and recovered completely. She was just worried about the second dose. The outcome of events was recovered on 30Dec2020.; Sender's Comments: Based on the compatible temporal association and the drug's known safety profile, the vaccination with BNT162B2 might play a contributory role in triggering the onset of the reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
54 2021-01-14 palpitations, chest discomfort 1826: Pt reported feeling like her heart was racing. R hand tremors noted. Pt reported history of SV... Read more
1826: Pt reported feeling like her heart was racing. R hand tremors noted. Pt reported history of SVT with first dose of some new medications. Pt reports intermittent SVT and PVCs post ablasion. HR 136, regular rhythm. 1828: 176/101 (119), HR 108, Resp 22, 99% on room air Pt reports feeling like her HR is returning back to normal, hand tremors continue. Reports mild shortness of breath, which is typical with her SVT episodes. 1831: 151/82 (98), HR 81, regular rhythm, Resp 12, 98% on room air. Denies any worsening or any additional symptoms. Hand tremor no longer present. 1839: 151/104 (113), HR 76, regular rhythm, Resp 10, 98% on room air. Pt reports headache and mild nausea that is typical with her SVT episodes. Pt appears relaxed sitting in chair. 1845: HR 78, regular rhythm. Pt remaining in monitoring area for 15 additional minutes. No s/s further distress. Pt calling husband to take her home. 1905: BP 157/91 (107), HR 87, regular rhythm, 98% on room air, Resp 14 Pt c/o numbness to L arm with some L chest tightness. Reports this sometimes happens with her SVT episodes. 1907: No further chest tightness or L arm numbness. Pt reports feeling anxious. Does not want to go to the ED for further monitoring. Continues to report that her symptoms feel typical after her SVT episodes with some additional nausea. 1910: 132/112 (117), HR 78, regular rhythm. Pt reports improvement of symptoms. Pt relaxed in chair. Instructed pt to stop and call 911 if she has any concerning symptoms after leaving clinic including difficulty breathing or HR abnormalities.
54 2021-01-14 blood pressure increased Around 1330, approx 11 minutes after receiving her vaccine the EE was in the observation area. She ... Read more
Around 1330, approx 11 minutes after receiving her vaccine the EE was in the observation area. She felt a sudden weakness from head to toe and felt an impending sense of doom. She began to feel dizzy and panicked. EE moved to evaluation area at 1333. HR78 BP 174/96 O@ 97%RA. Pt was anxious and noted BP was high for her. FNP continued chatting to EE. EE declined the ED at this time. A&O x4. 1350 HR 75 BP 151/94 O@97%. EE reports feeling much beter. EE opted to wait in the observation area an additional 30 minutes, declining again to go to ED for further evaluation. EE will call if her condition changes.
54 2021-01-14 fast heart rate Hives within 2 hours and then onset of Tachycardia lasting 36 hours on and off.
54 2021-01-14 blood glucose increased Left arm sore, instantly nauseous for 2 hours, metallic taste in mouth for 2 hours. Fasting glucose... Read more
Left arm sore, instantly nauseous for 2 hours, metallic taste in mouth for 2 hours. Fasting glucose was 89 in the morning. by 1400 hours my glucose was 250. By bed time it was 300. I did not eat dinner and adjusted my insulin and took an extra 500mg metformin. I had chills and fever through the night and all the next day. Fever 99 to 101. Tylenol and showers used to control fever. I was very sleepy all that day. I was sleepy with the first shot also. I woke up on Jan. 6, 2021 with a hemorrhage in my right eye. I called the retinol specialist and was given a shot of Eylea in my right eye Jan. 7, 2021., He asked that I report this advers reaction.
54 2021-01-14 blood glucose increased Pain in left arm. Joint pain, I immediately had nausea and a metallic taste in my mouth for 2 hour... Read more
Pain in left arm. Joint pain, I immediately had nausea and a metallic taste in my mouth for 2 hours. Mysugar climbed to 250 by dinner time. By bed tme my sugar was 300. I did not eat dinner. I had no appectite. I increased my insulin and metformin dose. I had chills and fevery thru the night and the next day. High fever 101. I treated this with tylenol and showers. I was really sleepy all day. I had little to eat and still my sugar was 300 most of the day. on Jan 6. I woke up and had a hemmorrhage in my right eye. I called my retinol specialist and and received an injection of Eylea on Jan 7, 2021
54 2021-01-14 palpitations, blood pressure increased Patient's heart felt racing, started to get clammy and flushed 10 minutes after receiving the vaccin... Read more
Patient's heart felt racing, started to get clammy and flushed 10 minutes after receiving the vaccine.
54 2021-01-14 blood pressure increased Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Rash (oth... Read more
Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Rash (other than injection site)-Medium, Systemic: Chills-Mild, Systemic: Increase in BP to 184/91; symptoms lasted 1 day
54 2021-01-14 fainting Syncope. Rested and recovered. Fainted about 5 minutes after receiving the vaccine- walked quickly... Read more
Syncope. Rested and recovered. Fainted about 5 minutes after receiving the vaccine- walked quickly from the vaccination station to the observation station, and was seen wobbling, caught her and laid her until she recovered. She was embarrassed, indicated she has fainted with shots before.
54 2021-01-15 chest discomfort At approximately 20 min following dose administration noted left neck pain subsequently developed pe... Read more
At approximately 20 min following dose administration noted left neck pain subsequently developed perioral paresthesia, chest tightness. No stridor, drooling, wheezing or nausea/vomiting. Vitals were stable. Patient states that she took Claritin prior to her vaccination. No medications since symptoms started. States symptoms have improved in all told lasted approximately 30 min.
54 2021-01-15 palpitations Dizziness and Palpitations within 15 minutes of vaccine administration
54 2021-01-16 fainting Sudden onset of extreme vertigo with associated near syncope (felt like vagal). No vomiting and no r... Read more
Sudden onset of extreme vertigo with associated near syncope (felt like vagal). No vomiting and no real nausea. Vertigo still present but now minimal. That same night I had a mild fever, but I am not concerned by this. Had some mild vertigo after the first vaccination (lot EH9899) but it only lasted 48 hrs.
54 2021-01-17 pallor Dose #1 ER5730 12/30/2020. From day 1 post injection 2 - repeat symptoms of extreme SOB on ambulati... Read more
Dose #1 ER5730 12/30/2020. From day 1 post injection 2 - repeat symptoms of extreme SOB on ambulation - worse than with #1. RR 36+ O2 sat stayed at 93 or above with ambulation. HR in supine position 70 w/in 10-15 seconds of ambulation greater than 105. On day 6 post injection, with bagging up a bag of garbage (bending over and picking things up with a spilt can) I had to sit down I was that SOB. HR 130 on pulse ox - O2 sat. 94-95. Day 7 post injection - ER work up for PE - negative, chf evaluation - negative. no pneumonia or cardiomegaly on CTA. CBC all w/in normal limits except on diff - lymph 0.5 above normal range only. CMP ok as well. BMP and trops normal. Day 9 diffuse itchy rash has developed, even worse now on day 10. Raised, blanching, papules - no pustules/vesicles noted. Trunk presentation spreading to extremities. leg signifiant more populated than arms. Rash now on tops and bottoms of feet. Minimal spots on dorsal hands and none on palms. Extremely itchy. + Celiac patient (Dx- genetically 7-8 years ago, symptoms for over 10) and + Hashimotos patient (29 years). No recent gluten exposure resulting in GI response. (I can get bowel incontinence with cross contamination. ) I'm taking Synthroid as prescribed. Since I'm in the CD8 peak days (9-11)- can this just be some type of autoimmune storm since it was a viral vaccine? No history of any problems with my yearly influenza vaccine.
54 2021-01-17 chest discomfort c/o chest tightness, SOB, anxiety
54 2021-01-18 hypertension, fast heart rate 2 min. after vax with dizzyness, mild tachycardia and hypertension. Taken to ED. Observed x 2 hours... Read more
2 min. after vax with dizzyness, mild tachycardia and hypertension. Taken to ED. Observed x 2 hours, improved, D/C.
54 2021-01-18 palpitations Body aches and swollen glands under left arm for first 28 hrs. After 28 hrs fever built up to 101.2... Read more
Body aches and swollen glands under left arm for first 28 hrs. After 28 hrs fever built up to 101.2 along with rapid heart beat, increased body aches, pounding heart and sweating. Symptoms lessoned in the morning. Fever returned the next evening (Friday 1/15). Cleared by Saturday except for tiredness. Entire episode completed by Saturday morning 1/16/21. No hospitalization or MD visit. Would have visited my Primary MD, but they referred me to the organization administering the vaccine. Vaccine was given out at work, there isn't a medical clinic available for employees.
54 2021-01-18 heart rate increased Flushed, elevated heart rate
54 2021-01-19 chest discomfort Patient complaint of "warm feeling" in chest and feeling anxious. Nurse checked vitals, monitored fo... Read more
Patient complaint of "warm feeling" in chest and feeling anxious. Nurse checked vitals, monitored for 15 minutes and check vitals again. Vital signs within normal limits. Patient stated warmth in chest completely resolved. Patient monitored for 30 minutes total, the discharged to home.
54 2021-01-19 chest pain, palpitations, fast heart rate Rash, SOB, Flushing, fever, severe Chills, HA, Dizziness, Tachycardia , Muscle pain/weakness, chest ... Read more
Rash, SOB, Flushing, fever, severe Chills, HA, Dizziness, Tachycardia , Muscle pain/weakness, chest pain, palpitations--Treated with EpiPen onsite, Ambulance--Epi/O2/Monitoring---ER IV benadryl/ IV Solumedrol/ IV dexamethasone--Sent home 5 hrs later with oral benadryl and predinsone
54 2021-01-19 palpitations, chest discomfort Recipient reported waking with chest tightness, chills, heart racing, pulse- 124-126, shortness of b... Read more
Recipient reported waking with chest tightness, chills, heart racing, pulse- 124-126, shortness of breath chocking sensation and dry throat. Worried about her breathing, she went to the emergency department, blood pressure taken- 183/103. She was given IV fluids and recommended follow up with PCP.
54 2021-01-20 palpitations 2nd dose PFizer EL 3246, dizzy, high temp, severe chills uncontrollable for 2 hours, body aches, he... Read more
2nd dose PFizer EL 3246, dizzy, high temp, severe chills uncontrollable for 2 hours, body aches, heart palpitations. called dr tierney, she told me to get covid test. I feel better 24 hours later but still have body aches and very lethargic.
54 2021-01-20 palpitations After first shot had palpitations and nausea for 24 hours. ( I did report prior to taking second dos... Read more
After first shot had palpitations and nausea for 24 hours. ( I did report prior to taking second dose) After second shot developed shortness of breath and nausea. Particularly bad with having to don mask. Did not go to ER or doctor. Has resolved somewhat' but still not able to tolerate mask.
54 2021-01-20 blood pressure increased Patient reported throat and mouth tingling approximately 10 minutes after vaccination. She identifie... Read more
Patient reported throat and mouth tingling approximately 10 minutes after vaccination. She identified herself to staff. She stated that she usually takes Benadryl when she has these symptoms. She had an elevated blood pressure at the time (BP= 180s/110s. She proceed to take 50mg Benadryl. Approximately 20 minute later, she developed coughing and continued tingling of her perioral area and that the tingling was extending to her nose and forehead. At which time, she said that she would use her Epipen at such a time. She self administered an Adult Epipen. Approximately 10 minutes, her symptoms improved. She continued to cough and have elevated BP. She was transported via EMS to the nearest ER in stable condition.
54 2021-01-20 chest discomfort chest tightness, chills, low grade fever, bodyaches
54 2021-01-21 chest discomfort Tightness in throat and chest. Approx 8 hours after vaccine malaise, muscle aches, fever, headache
54 2021-01-22 fast heart rate, hypertension Received vaccination at 11:10. Waited 12 minutes in observation and left because felt fine. At 11:45... Read more
Received vaccination at 11:10. Waited 12 minutes in observation and left because felt fine. At 11:45 while driving home, experienced numbness and tingling in my whole face like receiving a novacaine injection at the dentist. A few minutes later experienced tachycardia. A few minutes later, experienced a walnut sized lump in my throat that was more evident with swallowing. Voice was also raspy, but did not experience any difficulty breathing. Got off the highway and went to a hotel lobby to call 911 as my cell phone battery was about to die. This was around 12 noon. BP was 160/94 which is high for me; usually runs 90-95 systolic. Was transported to the ER. Next BP was 150/84. Upon arrival to the ER, the symptoms described had not worsened. Was discharged later that day around 5 PM. No treatment was administered. The next day, arm very sore, had joint aches and felt tired. By 1/23/2021 had mild arm soreness without other symptoms.
54 2021-01-24 loss of consciousness, chest discomfort Pt reported "tightness" in chest and stumbled then collapsed on stairs near exit. Pt was beginning ... Read more
Pt reported "tightness" in chest and stumbled then collapsed on stairs near exit. Pt was beginning to lose consciousness. RN administered two doses of 0.3mg EPI Pen three minutes apart. Pt became more alert and reported improvement in respiratory status. EMS transported patient to hospital.
54 2021-01-25 chest discomfort After about between 10 to 15 minutes of the shots, started feeling hot and cold symptoms of your abo... Read more
After about between 10 to 15 minutes of the shots, started feeling hot and cold symptoms of your about to pass out. Then tightness of chess where its hard to breath. EMS were around to give me 2 shots of Epi one at a time with the interval of about 5 to 15 minutes. the first Epi was OK but still having hard time breathing and the second one feels a lot better but cant stop shivering's. then I was transferred to emergency room and treated also with some allergy med. (Benadryl administer through IV)
54 2021-01-25 heart rate increased, pallor heart rate increased; pale; diaphoretic; This is a spontaneous report from a contactable nurse. A 54... Read more
heart rate increased; pale; diaphoretic; This is a spontaneous report from a contactable nurse. A 54-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL1284 and expiry date unknown) intramuscular in the left arm on 12Jan2021 15:30 at single dose for Covid-19 immunization in a workplace clinic. Medical history included hypertension, asthma, hysterectomy and tumor debulking (reported as on 21Dec2021). The patient was not pregnant. Concomitant medications included hydrochlorothiazide, asthma medication and antibiotic; all from unspecified date for unspecified indication. The patient previously took erythromycin and experienced allergies. On 12Jan2021 15:45 (also reported as approximately 9 minutes post injection), the patient reported feeling her heart rate increased, was pale and diaphoretic. The patient was not COVID tested post vaccination. The patient did not receive treatment due to the events. The outcome of the events heart rate increased, pale and diaphoretic was recovered on Jan2021.
54 2021-01-26 heart rate increased "THICK TONGUE"/"THROAT DRY" INCREASED PULSE 90-100 BPM
54 2021-01-26 chest pain Patient complained of feeling light headed and dizzy 3-5 minutes after receiving Pfizer COVID-19 vac... Read more
Patient complained of feeling light headed and dizzy 3-5 minutes after receiving Pfizer COVID-19 vaccine. (per son accompany by patient for vaccine). Pt then became SOB and complained of chest pain. Patient appeared disoriented. EMS already station on the scene was notified by staff. Patient evaluated by EMS.( Patient's son reported patient had mild reaction after 1st vaccine but recovered quickly). Patient was taking to ER by EMS for further evaluation.
54 2021-01-26 heart rate increased Started feeling kind of off almost immediately after getting the vaccine. Felt flush and a little we... Read more
Started feeling kind of off almost immediately after getting the vaccine. Felt flush and a little weak. Thought I was imagining things. Walked outside took elevator to the car felt increasingly more dizzy and weak. Got to car and started it, drove a few feet then knew it was dangerous to drive. parked and called My husband. He alerted people he knew . I then called 911. Symptoms progressively worsened. Thought I was going to code. Went to Er by ambulance. Trembling, dizziness, fast heart rate continued. Felt like i was going to die and my heart was going to jump out of my chest. In emergency room, they did an ekg and chest X-ray which were normal. They did some blood work. My potassium was very low ? 3.3. My TSH was 0.05; glucose 108;auto absol basos 0.1. Other results were normal. They told me the reaction was due to my low potassium and TSH levels. ER doctor recommended to change my levothyroxine dose with my pcp. Was in ER from approximately 1 pm - 6 pm on 1/7/21. They had me drink potassium and sent me home. Some symptoms subsided but still felt weak and dizzy when I left.
54 2021-01-27 palpitations intermittent palpitations; This is a spontaneous report from a contactable consumer (patient). A 54-... Read more
intermittent palpitations; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received the first dose of bnt162b2 (Covid vaccine, reported as Pfizer product) lot no: EL0142, via an unspecified route of administration in left arm on 12Jan2021 at a single dose for COVID-19 immunization. There were no relevant medical history and concomitant medications. The patient experienced intermittent palpitations on 12Jan2021. She has been having palpitations since she received the vaccine, did not start having them until about 8 hours after, stated she has had palpitations on and off since then. The patient had not recovered from the event.
54 2021-01-28 blood glucose increased, blood pressure increased About 15 minutes after vaccination she reported feeling light headed and nauseous like the start of ... Read more
About 15 minutes after vaccination she reported feeling light headed and nauseous like the start of a panic attack. She tried to walk outside for fresh air, but had to sit down after about 20 feet of walking. She reported more nausea, feeling very hot, and had a hard time communicating. She was given a cool washcloth and fanned while being held up by a support person. Her blood pressure was initially high, and rose significantly over a period of about 5 minutes. Blood sugar was checked and was 475 mg/dL. 911 was called, and after about 10 minutes of supportive care paramedics transported her to the hospital. She was fairly limp at time of transport and had a hard time standing. The facility staff updated me several hours later that they had heard that she was doing well. It appeared to be a panic attack.
54 2021-02-01 heart rate increased heart rate 160 (elevated); she had an allergic reaction to the vaccine; fever of 102; chills; irrita... Read more
heart rate 160 (elevated); she had an allergic reaction to the vaccine; fever of 102; chills; irritation in throat; Diarrhea; felt funny; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received bnt162b2 (BNT162B2 reported as Pfizer COVID 19 vaccine; lot number: EL3302; expiration date: unknown), via an unspecified route of administration left arm on 15Jan2021 09:30 at a single dose (reported as unknown dosage with a needle to left arm one time) to prevent Covid 19 and build up antibodies to Covid 19 (COVID-19 immunization). The patient has no medical history and concomitant medications. The patient reported that last Friday (15Jan2021) at 9:30 she took the first dose of vaccine and felt funny, so she waited for 15 minutes. She mentioned that she had not eaten before so they gave her glucose tablets. She then mentioned that later on that night (15Jan2021) that she had a fever of 102 [unit unspecified], elevated heart rate of 160 [unit unspecified], had chills and felt like she had Covid. She further stated that she had irritation in her throat that started after the vaccine. She stated that her doctor mentioned that she may be positive for Covid 19 and did not know it before she had the vaccine. The patient mentioned that she had the nasal swab for Covid and they drew her blood on an unspecified date, but all came back negative. She was told that she had an allergic reaction to the vaccine. She added that she had no symptoms prior to the vaccine. The patient reported that she has to go back for the second Pfizer Covid 19 vaccine on 05Feb2021. The patient received treatment included prednisone, diphenhydramine (BENADRYL) and was given an epinephrine injection (EPIPEN) to bring home. She also was given acetaminophen (TYLENOL) for fever. She was given fluids to try to bring everything down. She added that she was given famotidine (PEPCID) for her stomach due to diarrhea on 15Jan2021 that she is still taking. The outcome of the events allergic reaction and felt funny were unknown, as for diarrhea was not recovered, for the event irritation in throat was recovered on 15Jan2021 while the outcome of the other events was recovered on 17Jan2021.
54 2021-02-01 fainting kind of fainted; Body feels tender and skin feels tender to touch; dizziness; Weakness; Fatigue; Hea... Read more
kind of fainted; Body feels tender and skin feels tender to touch; dizziness; Weakness; Fatigue; Headache; Chills; Left arm hurting really bad; A 54-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 18Jan2021 07:15 at single dose in left arm for covid-19 immunisation. Medical history included menopause from May2020 and ongoing (She is going through menopause, which started 7 months ago). There were no concomitant medications. Received call from consumer regarding the Pfizer BioNtech COVID vaccine. She had first vaccine yesterday morning and is experiencing some side effects. It looks like it was prescribed by a pharmacist, but she is not able to see the name and does not have any contact details to provide. She signed up at the online thing for reporting. Her arm is much better this morning. She woke up at 03:00 with the headache and still has it. Dizziness and weakness started 06:30 this morning. She kind of fainted. She was walking from one room to the next and she just gave out. It has improved and she is not really dizzy any more. She is having a little fatigue though. Chills began at 06:30 and they come and go. She is going through menopause and it could have something to do with it. She was unable to answer outcome for this. She just wants the headache to stop. She has not been able to do anything today. She is going through menopause, which started 7 months ago. She would like to know if there is something she can take for the headache. AE Details and time of onset: Left arm hurting really bad 18:00. When she first got it, she did not feel it. As the day progressed, she could feel the pain. Headache 03:00. Dizziness and weakness 06:30. Fatigue 06:30. Chills 07:00-07:30. She layed down at that point. Body feels tender and skin feels tender to touch 09:00. NO ER or physician's office required. No prior Vaccinations (within 4 weeks). The outcome of the event dizziness was resolved, Chills was unknown, Headache was not resolved, while the outcome of the other events was resolving. Information on the lot/batch number has been requested.
54 2021-02-02 palpitations, hypertension swelling lips; numbness; rashes in the face and legs; high blood pressure; itching; nauseas; diahrre... Read more
swelling lips; numbness; rashes in the face and legs; high blood pressure; itching; nauseas; diahrrea; palpitation; Headache; This is a spontaneous report from a contactable other healthcare professional (patient). A 54-year-old female patient (non-pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 14Jan2021 13:15 at single dose at left arm for covid-19 immunization. Medical history included known allergies: sulfas, codeine, latex. Concomitant medications were not reported. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine, patient didn't receive other medication within 2 weeks of vaccination. After 22 minutes received the vaccine on 14Jan2021: started swelling lips, numbness, rashes in the face and legs, high blood pressure, itching and headache, nauseas and diarrhea, until now still felling palpitation and headache. The adverse events resulted in emergency room/department or urgent care. Patient received treatment famotidine 20 mg, epinephrine for events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient had not been tested for COVID-19. Outcome of events palpitation and headache was not recovered, and outcome of other events was recovered with lasting effects in Jan2021. Information of lot/batch number has been requested.; Sender's Comments: The reported events swelling lips, numbness, rashes in the face and legs, high blood pressure, itching, nauseas and diarrhea, palpitation and headache, were causally related to the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), due to plausible temporal relationship and clinical course. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
54 2021-02-03 heart rate increased, chest discomfort approx. 15 minutes after injection c/o chest tightness, slightly lightheaded, HR increase. Vitals: ... Read more
approx. 15 minutes after injection c/o chest tightness, slightly lightheaded, HR increase. Vitals: 112/78, HR 69, 16 RR,A/0x3, As time progressed c/o achiness when she turns head side to side. 7:12pm c/o head felt foggy, improved chest tightness, heaviness in abdomen, achiness in R) arm pitdenies SOB, BP:110/78, Hr 66, 7:25: felt HR flutter occasionally, heaviness in legs increased and cont. light headed. but ROM WNL, Denies numbness/tingling, denies SOB, no swallowing problems during entire time. Couldn't go back to work and went home with nursing instructions if heaviness were to increase or other symptoms worsen to call 911 or go to ER. Taken home by mother and brother. called next day and symptoms improved.
54 2021-02-04 nosebleed Headache; tiredness; nose bleeding; This is a spontaneous report from a contactable consumer (patien... Read more
Headache; tiredness; nose bleeding; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3248, expiration date was unknown), via an unspecified route of administration in the left arm on 20Jan2021 01:30 at a single dose for COVID-19 immunization. Medical history included chronic migraine from an unknown date and unknown if ongoing. Concomitant medication included citalopram and trazodone. The patient was not pregnant. The patient had no other vaccine in four weeks prior vaccination. She had no covid prior vaccination nor was she tested post vaccination. The patient experienced headache, tiredness, she had a nose bleed and added that most of the time, if she had a headache, her nose will bleed. The events occurred on an unspecified date in Jan2021 at 03:00 AM with outcome of recovered in Jan2021. No treatment received for the events.
54 2021-02-04 blood pressure increased PATIENT INITIALLY COMPLAINED OF DRY MOUTH, METALLIC TASTE WHICH PROGRESSED TO NUMBNESS AND TINGLING ... Read more
PATIENT INITIALLY COMPLAINED OF DRY MOUTH, METALLIC TASTE WHICH PROGRESSED TO NUMBNESS AND TINGLING IN MOUTH AND THROAT. PATIENT BEGAN TO FEEL DIZZY AND WAS PLACED INTO TRENDLENBERG POSITION FOR 20 MINUTES, AFTER WHICH SHE RETRUNED TO HIGH FOWLERS POSITION. SHE CONTINUED TO COMPLAIN OF NUMBNESS AND TINGLING IN MOUTH AND THROAT AND PATIENT REQUESTED EMS BE CALLED. PATIENT WAS NEVER IN ANY APPARENT RESPIRATORY DISTRESS, HR STRONG AND REGULAR, INITAL BLOOD PRESSURE MILDLY ELEVATED, SUBSEQUENT ONES WERE WNL.
54 2021-02-04 blood pressure increased Spike in BP, feeling of a lump in throat, pt feels hot and nauseous, 50 mg of generic Benadryl orall... Read more
Spike in BP, feeling of a lump in throat, pt feels hot and nauseous, 50 mg of generic Benadryl orally administered with water, pt went by ambulance to the hospital
54 2021-02-04 blood pressure increased Spike in BP143/98, unusual feeling in throat, 50mg of Benadryl administered with water, pt BP came d... Read more
Spike in BP143/98, unusual feeling in throat, 50mg of Benadryl administered with water, pt BP came down to 124/82 HR 89 O2 97%, The doctor on site is monitoring her
54 2021-02-04 palpitations palpitations; nauseous; This is a spontaneous report from a contactable nurse (patient). A 54-year-o... Read more
palpitations; nauseous; This is a spontaneous report from a contactable nurse (patient). A 54-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on 29Dec2020 08:30 at a single dose on left arm for COVID-19 immunization. Medical history included hypertension and obesity. The patient's concomitant medications were not reported. The patient previously took Dilaudid and experienced allergies. With first shot-immediately after (on 29Dec2020) had palpitations. Was nauseous times 24 hours on an unspecified date. The outcome of the events was unknown. The patient was not pregnant. Facility type vaccine was Hospital. No other vaccine in four weeks. Not diagnosed with COVID prior vaccination. Not COVID tested post vaccination.
54 2021-02-05 heart rate increased High heart rate, chills, excruciating headache eyes hurting muscle aches, TMJ joints hurting, dizzy ... Read more
High heart rate, chills, excruciating headache eyes hurting muscle aches, TMJ joints hurting, dizzy and nauseous
54 2021-02-05 chest pain Pt complained of chest pain within 5 minutes of vaccine at mass vac event. Pt monitored one on one b... Read more
Pt complained of chest pain within 5 minutes of vaccine at mass vac event. Pt monitored one on one by Dr. pain 8/10 to 5/10 to 2/10 after 10-12 minutes. no SOB, no deficit, no rash, no abd cramping.
54 2021-02-07 blood pressure increased Increase in blood pressure compared to baseline and headache beginning within two days of first vacc... Read more
Increase in blood pressure compared to baseline and headache beginning within two days of first vaccine dose. Occipital headache and elevated blood pressure persisted for over two weeks after vaccine and as of reporting date have not resolved.
54 2021-02-07 palpitations next day fever and palpitations. Coming and going for days. on 2/4/2021 started having LLE and RLE... Read more
next day fever and palpitations. Coming and going for days. on 2/4/2021 started having LLE and RLE numbness and tingling. Went to ED given hx of CVA. Testing all normal. Started to resolve 2 hours later. Continues to have pain at injection site (today is 2/8/2021)
54 2021-02-09 blood pressure increased, heart rate increased Immediately post vaccine patient complained of metallic taste in mouth, itchy tongue, diaphoresis an... Read more
Immediately post vaccine patient complained of metallic taste in mouth, itchy tongue, diaphoresis and shortness of breath. On VS Heart rate and blood pressure were elevated O2 sat was WNL. Patient w as placed in a supine position and VS were repeated after 15 min and she felt better and VS were now WNL
54 2021-02-09 platelet count decreased, low platelet count Severe thrombocytopenia (Platelets = 5) and diffuse petechial rash to trunk and extremities
54 2021-02-10 platelet count decreased, haemoglobin decreased, fibrin d dimer increased Patient received dose 1 of COVID-19 vaccine on 1/15/2021 and dose 2 on 2/5/2021. Approximately 1 wee... Read more
Patient received dose 1 of COVID-19 vaccine on 1/15/2021 and dose 2 on 2/5/2021. Approximately 1 week after the 1st dose, patient said she developed a rash. On presentation on 2/10/21, the rash appeared to be petechial in nature. Prior to coming to the hospital, the patient had blood work done at her ALF and was told she had zero platelets and she was sent to the hospital. Admission labs at the hospital on 2/10 also showed zero platelets and immune thrombocytopenia is suspected.
54 2021-02-18 platelet count decreased Patient had low platelets and had to have a platelet transfusion; This is a spontaneous report recei... Read more
Patient had low platelets and had to have a platelet transfusion; This is a spontaneous report received from a contactable nurse. A 54-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3248, Pfizer product), via an unspecified route of administration on right arm on 07Jan2021 at single dose for COVID-19 immunization in hospital. The patient's medical history included ongoing possibly has rheumatoid arthritis. No known allergies to medications, food, or other products. Concomitant medication included meloxicam (MOBIC) and multivitamin. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Pfizer product), intramuscularly on left arm on 17Dec2020 (54-year-old, Lot number: EH9899) at single dose for COVID-19 immunization. The patient did not diagnose with COVID-19 prior to vaccination. The patient did not test for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 04Feb2021 11:00, the patient experienced low platelets and had to have a platelet transfusion. The patient visited doctor or other healthcare professional office/clinic and visited emergency room/department or urgent care due to the event. The event was considered as non-serious by the nurse. The outcome of the event was not recovered.; Sender's Comments: Based on the temporal relationship, the association between the event low platelets requiring platelet transfusion with BNT162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
54 2021-02-21 chest pain Approximately 15 minutes post-vaccination (0830), pt started feeling dizzy, nauseous and had one epi... Read more
Approximately 15 minutes post-vaccination (0830), pt started feeling dizzy, nauseous and had one episode of emesis. Vital signs at 0830 were bp:184/108, p:112, SpO2:99%. At this time pt was flushed, skin was hot and dry. Vitals at 0835 were bp:179/124, p: 92. Pt began feeling chest pain. Vitals at 0840 were bp: 182-108, p:86. Emergency services were called and pt was transferred to local ED.
54 2021-02-21 blood pressure increased This was my first vaccine... almost immediately I had a headache and my blood pressure went up. I s... Read more
This was my first vaccine... almost immediately I had a headache and my blood pressure went up. I stayed for 45 minutes after my vaccine due to my blood pressure was high. I also felt a little fuzzy. About an hour later I got nauseous, had chills and felt very fatigued. The next morning when I woke up, my left eye was crusted over. I did not think anything of it until I got the second vaccine and it crusted over with it as well. I was very fatigued for 2 1/2 days. Arm was a little sore.
54 2021-02-22 palpitations, chest pain, chest discomfort Around 0840 on 2/16/2021 Heart Palpitations, swelling of tongue, left sided neck swelling with dimin... Read more
Around 0840 on 2/16/2021 Heart Palpitations, swelling of tongue, left sided neck swelling with diminish flow, tingling of the lips and tongue, pressure, tightness and pain in the chest. shortness of breath, right sided weakness and tingling of limbs and face. 50 ml of Benadryl, and 2 shots of epinephrine was given before transported to the Emergency Room via Ambulance On 2/22/2021 was sent to Urgent Care with the same symptoms. Urgent care sent me back to the Emergency room with heart arrythmias, chest tightness, tingling of lips and tongue.
54 2021-02-22 fast heart rate Cough, shortness of breath, tachycardia. Transported to ER. Tryptase drawn - 4.6. Symptoms resolved ... Read more
Cough, shortness of breath, tachycardia. Transported to ER. Tryptase drawn - 4.6. Symptoms resolved with benadryl
54 2021-02-22 palpitations PATIENT IN OBS AREA FOR 10 MIN WHE SHE BEGAN TO FEEL"PANICKY WITH HEART RACING. HR 144 BP 148/88. ... Read more
PATIENT IN OBS AREA FOR 10 MIN WHE SHE BEGAN TO FEEL"PANICKY WITH HEART RACING. HR 144 BP 148/88. REDIRECTION AND REFOCUS ATTEMPTED WITH GOOD EFFECT AS NOTED BY HR DECREASE TO 88-103 AND BP 130/88 100% PATIENT DENIED SOB AND CHEST PAIN. MARKED DECREASE IN SYMPTOMS WHEN CALM, HOWEVER, DIFFICULT TO KEEP HER CALM AND SHE WAS CONVINCED THE VACCINE WAS THE CAUSE OF THE SYMPTOMS. DECISION MADE TO TAKE PATIENT TO THE ER FOR EVALUATION. VS ON D/C 98- 138/73 100%; REPORT GIVEN TO RN ER CHARGE
54 2021-02-22 chest discomfort Patient became mildly short of breath with some chest tightness and light headedness approximately 2... Read more
Patient became mildly short of breath with some chest tightness and light headedness approximately 23 minutes after receipt of the vaccine. She notified the nursing counter who notified me. Patient was A&Ox3 upon my arrival and able to speak in full sentences. Heart rate was noted to be 105 bpm. 50mg oral Benadryl was administered and patient was monitored for 25 minutes. Heart rate improved as did patient's work of breathing, chest tightness, and her dizziness subsided completely. Her final heart rate at time of discharge was 93 bpm and patient was able to ambulate under own power to depart the site. She was escorted to her husband's vehicle and he received instructions to take her to the hospital to fill her epi-pen prescription which was placed at the time of the incident as well as reasons to use the epi-pen and report to ED if needed.
54 2021-02-22 chest discomfort Patient developed red rash neck, chest and arms. Bilateral Eye swelling. Chest tightness. Denied dif... Read more
Patient developed red rash neck, chest and arms. Bilateral Eye swelling. Chest tightness. Denied difficulty breathing. Benadryl 25mg IM administered and transferred to Emergency Room for further treatment.
54 2021-02-23 blood pressure increased Hives/swelling/puritis (of head/face, neck, chest, arms) and elevated blood pressure. IM Benadryl at... Read more
Hives/swelling/puritis (of head/face, neck, chest, arms) and elevated blood pressure. IM Benadryl at vaccination site IM steroid and prescription for steroids in ED
54 2021-02-24 palpitations 11:52 Nurse alerted by Client that she felt like her heart was racing. 11:53 Client taken for furthe... Read more
11:52 Nurse alerted by Client that she felt like her heart was racing. 11:53 Client taken for further assessment. Client also reports tingling in the fingers. Client was offered water which was taken and a seat by an open door for air. Client removed mask. Vitals taken: BP 185/100, Pulse 136. 11:59 Vitals taken: O Sat 99% Pulse 162. Client experiencing faintness and dizziness. EMT assessed Client further. 12:01 Client reports a slight tightness in her throat but reports the dizziness is lessening. Client reports no difficulty breathing. Vitals taken: O Sat 99% Pulse 142. 12:04 Vitals taken: BP 163/108, Pulse 128. 12:06 Vitals taken: O Sat 99%, Pulse 118. Client reports dizziness and tightness in the throat is lessening and feeling better. 12:08 Vitals taken: Pule 100, O Sat 98%. 12:11 Client reports no dizziness and the tightness in her throat is getting better. BP 157/99 Pulse 98. 12:15 Client reports that she feels well enough to leave. Client did decide to take a Benadryl due to a little tightness remaining. Client denied feeling any other previous issues or dizziness. Client given a 25mg (one tablet) of Benadryl. Education given regarding Benadryl taken. Client is here with her husband and daughter. Husband was present and Client felt well enough to leave. Client was able to ambulate to the car unassisted and her husband was able to drive her home
54 2021-02-24 platelet count decreased, fibrin d dimer increased 14 days after first dose, high fevers (104.5-103), low platelet count, have had 4 weeks of multiple ... Read more
14 days after first dose, high fevers (104.5-103), low platelet count, have had 4 weeks of multiple tests, including CT scans, Lumbar puncture, abnormal lab work with no known cause. High lymphocytes count (abnormal lymphocytes), abnormal red blood cells, high D Dimer, etc.. Most recent labs show Monoclonal paraproteinemia, Im currently waiting to see a hematologist. Have seen internal medicine, infectious disease, rheumatology, . No one can determine the cause of the ongoing symptoms.
54 2021-02-25 blood pressure decreased, fainting After 2nd dose on 2/3/21, I waited 10 minutes and felt tingling and cold, heaviness and blood pressu... Read more
After 2nd dose on 2/3/21, I waited 10 minutes and felt tingling and cold, heaviness and blood pressure dropped significantly. They put me onto a gurney and monitored my BP and waited, gave me some juice and crackers, but I continued to have the sensation of fainting (syncope). They transferred me to the ER for further monitoring. After a while, it stabilized more, but still continued to happen throughout the day.
54 2021-02-26 chest pain Left side of face ear area fullness numbness progressed later to numb lip on left side and poor vis... Read more
Left side of face ear area fullness numbness progressed later to numb lip on left side and poor vision in left eye , chest pain in center of chest and walking imbalance
54 2021-02-26 palpitations, chest pain Tingling in head, dizziness, SOB, chest pain, palpitations, evaluated by EMS-cleared
54 2021-02-28 heart rate increased Developed sensation of increased heart rate about 10 minutes after injection along with anxiety. BP ... Read more
Developed sensation of increased heart rate about 10 minutes after injection along with anxiety. BP 144/88, p-93, O2sats- 99% on RA. Given water and symptoms resolved within 10 minutes. No chest pain, no shortness of breath, no sensation of tongue or lips swelling. Vitals rechecked 130/78, p-83 and O2sats- 99%. No further symptoms and patient expressed desire to leave.
54 2021-02-28 palpitations Itchy, and heart racing turned over care to AMR was given oral Benadryl transported to hospital.
54 2021-03-01 cerebrovascular accident, loss of consciousness I had my 2nd does of the Pfizer vaccine on February 27, 2021. The next morning I awoke with a very... Read more
I had my 2nd does of the Pfizer vaccine on February 27, 2021. The next morning I awoke with a very bad headache. I took and Advil. My husband was making breakfast. I came downstairs, ate, had a cup of coffee, then got a glass of water and an ice pack and sat on a recliner in the living room. I don't remember much of the rest. It was like a dream. My husband said I let out a yell, my arms flailed and my eyes were very strange. I lost muscle strength in my lift side mimicking a stroke. He called 911. I was taken to Emergency facility where I gained consciousness. I was then transferred to Hospital. So far every test has come back negative. I have an EEG scheduled for this Thursday.
54 2021-03-02 chest pain pt stated stated she woke up vomiting the next morning after receiving the vax. She also has develo... Read more
pt stated stated she woke up vomiting the next morning after receiving the vax. She also has developed flu like symptoms. Body aches, headache, chest pain, chills, abdominal cramps and diarrhea. Pt states she has not contacted her PCP at this time.
54 2021-03-03 loss of consciousness Patient received her vaccine at 1:12pm. She went to check out. The check out man reported that she d... Read more
Patient received her vaccine at 1:12pm. She went to check out. The check out man reported that she didn't feel well. I noticed that she started to slump over in her chair. I went to her. I asked if she wanted to lay on the hospital bed. She said she couldn't get up. She wanted cold rags. She was visibly sweating. I motioned another health care worker over so I could go get the rags. When I got back less than 30 seconds later, she was on the floor. My coworker reported she slumped out of the chair and was unconscious for about 10 seconds. Security called 911 , and I called the emergency phone number to the hospital. She came back around and did not want to go to ER. Dr listened to her. Lungs were completely clear. She reports she has a history of dizziness with all vaccines. She has never gone totally unconscious before. She has no history of diabetes or hypertension. She did not eat lunch before coming. BP 123/80 at start of the event. 27 minutes after the event bp was 99/69 with pulse 66. 52 minutes later bp 109/86 with pulse of 71. We did not want her to drive home. We had her call someone to be picked up. She was able to walk out of the building without assistance.
54 2021-03-03 chest discomfort lips numb, chest pressure, flushing, nausea. Evaluated by EMS-Cleared
54 2021-03-04 palpitations patient presented to hospital for heart palpitation in SVT 180-190's. Patient had no light headness ... Read more
patient presented to hospital for heart palpitation in SVT 180-190's. Patient had no light headness or dizziness. Patient was cardioverted and improved. Discharged 2/18. Per EAU, hospitalizations are to be reported irrespective of attribution to the vaccine
54 2021-03-13 heart rate increased, chest pain, blood glucose increased pt was anxious about getting the shot, stated she's diabetic with heart condition pre vaccine. dose ... Read more
pt was anxious about getting the shot, stated she's diabetic with heart condition pre vaccine. dose approx 1:20, at 1:28 said her arm was going numb and declined water and food. 1:33 continued tingling numbness of left arm and jawline, she again declined food and water. 1:43 hot, sweaty, ache in chest and rapid pulse feeling. called ems, gave water and crackers, 1:48 bp between 103/80 Pulse 94 to 127/79 pulse 86. 1:55 bp 156/113 pulse 88. said her arm was tingly and face going numb, feeling her heart flutter. when EMS arrived she said her blood glucose was 286 this am and she took Humalog then. normal bp 130s/80s pulse in 90s. Tx to hospital, FU 3/12&3/14 said she had throat closing and vax site numb and swollen
54 2021-03-14 atrial fibrillation increased AFib episodes; joint ache esp to left knee with pain; Headache; This is a spontaneous repo... Read more
increased AFib episodes; joint ache esp to left knee with pain; Headache; This is a spontaneous report from a contactable nurse (patient). A 54-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318), via an unspecified route of administration at arm left on 28Jan2021 at 11:00 (at the age of 54-year-old) at single dose for COVID-19 immunisation. The patient was not pregnant. Medical history included atrial fibrillation (AFib), depression, aortic stenosis and allergy to sulfa, all from an unknown date and unknown if ongoing. Concomitant medication included losartan, HCTZ, sertraline hydrochloride (ZOLOFT), vitamin D3, magnesium and cyanocobalamin (VITAMIN B12). The patient previously took LEVOQUIN and prednisone and experienced allergies. On 02Feb2021 at 08:00, the patient experienced increased AFib episodes, joint ache esp. to left knee with pain and headache. The patient underwent lab tests and procedures which included SARS-COV-2 (nasal swab) test: negative on 22Feb2021. Therapeutic measures were taken as a result of the events and included acupuncture and the events required physician office visit. The patient outcome of the event was not recovered.; Sender's Comments: There is not a reasonable possibility that event atrial fibrillation is related to BNT162B2. The event only occurred 4 days after vaccination. And the patient had underlying atrial fibrillation, which is considered the most likely cause of the reported event. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
54 2021-03-24 blood clot, nosebleed Had a major nosebleed with blood clots; Had a major nosebleed with blood clots; This is a spontaneou... Read more
Had a major nosebleed with blood clots; Had a major nosebleed with blood clots; This is a spontaneous report from a contactable consumer (the patient). A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1, intramuscular on 08Mar2021 (Batch/Lot Number: EN6199; Expiration Date: 30Jun2021) as single dose for COVID-19 immunisation. Medical history was not reported. There were no concomitant medications. The patient had a major nosebleed with blood clots on an unknown day in Mar2021. The patient reported that he never got nosebleeds before. There was no treatment taken for the event, it stopped on itself. The outcome of the events was unknown.
54 2021-03-24 lightheadedness, chest pain delirous as if I was hungover; delirous as if I was hungover; felt on the brink of fainting; chills;... Read more
delirous as if I was hungover; delirous as if I was hungover; felt on the brink of fainting; chills; joint pain; pain at the injection site; lethargic; dry cough; severely nauseous; could not eat; serious fogginess; General malaise; fatigued; a debilitating headache; did not feel comfortable driving; weak; hurt in my chest; slept the whole day; This is a spontaneous report from a contactable consumer. A 54-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, administered in the left arm on 05Mar2021 at 13:30 (Batch/Lot Number: EN6202) at 54-years-old as a single dose for COVID-19 immunization; administered in a hospital. The patient did not receive any other vaccine within four weeks of the suspect vaccine. Medical history included hypertension, and acne from an unknown date and unknown if ongoing. The patient did not have COVID prior to the vaccination. Concomitant medications included hydrochlorothiazide, olmesartan medoxomil (MANUFACTURER UNKNOWN) taken for an unspecified indication, start and stop date were not reported; isotretinoin (MANUFACTURER UNKNOWN) taken for an unspecified indication, start and stop date were not reported. The patient previously took (ceftriaxone sodium) ANCEF, start and stop date were not reported, and experienced drug allergy. On 06Mar2021 at 04:00 (as reported), the patient experienced: delirious as if i was hungover (medically significant), felt on the brink of fainting (non-serious), chills (non-serious), joint pain (non-serious), pain at the injection site (non-serious), lethargic (non-serious), dry cough (non-serious), severely nauseous (non-serious), could not eat (non-serious), serious fogginess (non-serious), general malaise (non-serious), fatigued (non-serious), a debilitating headache (non-serious), did not feel comfortable driving (non-serious), weak (non-serious), hurt in my chest (non-serious), slept the whole day (non-serious); with no treatment received. The clinical course was reported as follows: The patient reported that on the first night (as reported) she had chills, joint pain and pain at the injection site. The next day (as reported) she was lethargic and was severely nauseous to the extent she could not eat. The patient also experienced serious fogginess, felt delirious as if she was hungover. The patient felt general malaise and a debilitating headache all day. The patient was fatigued to the extent she did not feel comfortable driving. The patient was so weak, that she felt on the brink of fainting. That evening, the patient slept the whole night through, except when she would awake with a dry cough that hurt in her chest. This cough was not as persistent and intense but was lasting even now. The patient slept the whole day and was just now beginning to feel as if she had recuperated from the vaccine four days later. The clinical outcome of the events was recovered with sequelae on an unspecified date (also reported as "recovered with lasting effects"). The patient was not tested for COVID post vaccination.
54 2021-03-27 excessive bleeding Bleeding of gums; unbake to stop bleeding from puncture site; This is a spontaneous report from a co... Read more
Bleeding of gums; unbake to stop bleeding from puncture site; This is a spontaneous report from a contactable consumer. A 54-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6203), via an unspecified route of administration, administered in arm left on 27Feb2021 (at the age of 54-years-old) at 18:00 as a single dose for COVID-19 immunisation. Medical history included hypertension from an unknown date and unknown if ongoing. Concomitant medication included amiloride taken for an unspecified indication, start and stop date were not reported. On 01Mar2021 at 06:00, the patient experienced bleeding of gums beginning less than 48 hours after dose, then 1 week after dose, donated blood, "unbake" to stop bleeding from puncture site on Mar2021, tourniquet applied and blood soaked through, was oozing for 5 hours after. There was no treatment received for the events. The outcome of the events was unknown.
54 2021-03-28 blood pressure increased heart discomforted.; blood pressure 30 minutes after the injection, and it was 184/124; I felt immed... Read more
heart discomforted.; blood pressure 30 minutes after the injection, and it was 184/124; I felt immediate overall body weakness; slurred speech; lips tingling; disoriented; lightheaded; This is a spontaneous report from a contactable consumer. A 54-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6206), via an unspecified route of administration, at the age of 54 years, on the left arm on 08Mar2021 15:00 at a single dose for COVID-19 immunisation. Medical history included fibromyalgia, musculoskeletal disorder, drug hypersensitivity to penicillin, other food sensitivities and gluten sensitivity; all from an unknown date and unknown if ongoing. Concomitant medications included ibuprofen (ADVIL [IBUPROFEN]); ascorbic acid (C 500 [ASCORBIC ACID]); colecalciferol (D3) and magnesium (MAGNESIUM); all taken for an unspecified indication, start and stop date were not reported. The patient previously took progesterone, NP thyroid and lactose and experienced hypersensitivity. On 08Mar2021, the patient immediately felt the medications moving throughout her body. She felt immediate overall body weakness, slurred speech, lips tingling, disoriented, lightheaded, and heart discomforted. The medical staff took her blood pressure 30 minutes after the injection and it was 184/124. She stated she was not hypertensive. The final read before leaving the site was 149/90. No treatment was received for the events. The outcome of the events was recovering.
54 2021-03-29 troponin increased Completed my vsafe check in each day. Very mild symptoms. On day six I had what appeared to be a sev... Read more
Completed my vsafe check in each day. Very mild symptoms. On day six I had what appeared to be a severe asthma attack (no history of asthma) while working outside. Continued working and symptoms increased, oxygen levels dropped, ended up in ER with elevated triponin. Echo and angiogram both normal healthy heart.
54 2021-04-02 blood clot, pulmonary embolism After the first vaccine on 2/6/2021, I did not have any reaction except a sore arm until 2/10/2021 ... Read more
After the first vaccine on 2/6/2021, I did not have any reaction except a sore arm until 2/10/2021 when developed a bad headache causing me to leave work. When I awoke on 2/11/21 I felt worse as the day went on until I had complete flu like symptoms. On Friday, 2/12, I went to my primary care doctor and they did a COVID-19 test which was negative. Hence, I just waited for the reaction to go away, I was not better and able to resume normal activity until 2/15/21. I did decide to get the second shot as I was not entirely sure it was a result of the vaccine. On 2/27/2021, I received the second vaccination. Again, the immediate side effect was only a sore arm. On the following Monday (3/1/2021) see cont.I began to have what I thought was muscle aches and pains around the mid section on my body but they were manageable. On Tuesday and Wednesday (3/3/2021) the pain and area of the pain spread and intensified. I was unable to sleep or find a comfortable position and was losing strength and knew I needed medical attention as I was afraid it was a heart issue. My husband took me to the ER (3/4/2021). The ER doctor ran a CT scan with contrast and the result was a blood clot in my right lung and pneumonia in my left lung along with pleurisy. I was then admitted to Clinic on 3/4/2021. I remained in the hospital until 3/7/2021. There I was treated with IV antibiotics, warfarin, Lovenox (80mg), and pain medication for the pleurisy. I was also on a full time heart monitor and my heart was checked several times. Since returning home, I finished a dose of two antibiotics and am using an inhaler to help with breathing. I have also just finished a long dose of steriods. My INR is still not regulated to the therapeutic level. Prior to this reaction, I was in the therapeutic range and had been checked. As of 4/3/2021 I am at 1.8 not in the 2-3 range and have increased my dose from before the reaction at 7.5 mg to 9.0 mg daily.
54 2021-04-04 heart rate increased, chest pain The next day after the vaccine I had chest pains and severe headaches. After a week of this I went ... Read more
The next day after the vaccine I had chest pains and severe headaches. After a week of this I went to Urgent Care and they send me to the ER with Chest Pain and High Heart Rate. They were not able to get my heart rate down in the ER so they decided to admit me to hospital and run some tests on me. Several hundreds of dollars later they have no diagnosis. I am now on blood pressure medicine for a month to see if this helps my blood pressure.
54 2021-04-07 lightheadedness, hypertension Dizziness; clammy kind of feeling; low grade fever; feels kind of sweaty; felt like she was going to... Read more
Dizziness; clammy kind of feeling; low grade fever; feels kind of sweaty; felt like she was going to pass out; blood pressure was up; This is a spontaneous report from a contactable consumer reported for herself that at the age of 54- year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: unknown), via an unspecified route of administration on 15Mar2021 (at the age of 54-year-old), at a single dose for COVID-19 immunisation. Medical history included ongoing asthma. The patient's concomitant medications were not reported. Caller reports that since she received the vaccine on 15Mar2021, on the day of the vaccine, she felt like she was going to pass out and her blood pressure was quite high. Her blood pressure is usually about 120/70 something, but it was 160 or 155/96 on the day of the vaccine. The reporter stated, she has been experiencing a clammy kind of feeling, like she has a low-grade fever and she feels kind of sweaty on 16Mar2021. Caller make the comment that she is in her fifties and she knows what hot flashes feel like-your body gets hot, sweaty, and you get redness on your skin, and your temperature goes up. This feeling is different- she doesn't feel like herself and she doesn't feel right and she is not sure if this is related to the vaccine, but it started after she received the vaccine. The patient underwent lab tests and procedures which included blood pressure measurement: 120/70 on an unspecified date and on 15Mar2021 reported as: 160 or 155/96 on 15Mar2021. The reported events were considered as non-serious by the health authority. The outcome of the events clammy kind of feeling, low grade fever and feels kind of sweaty were not recovered and unknown for other events. Information for lot/batch number has been requested.
54 2021-04-12 chest discomfort neurological grand mal seizures; difficulty breathing; tight chest; sore achy bones, muscle; sore ac... Read more
neurological grand mal seizures; difficulty breathing; tight chest; sore achy bones, muscle; sore achy bones, muscle; This is a spontaneous report received from a contactable consumer (patient). A 54-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: ER8737), via an unspecified route of administration at the left arm on 27Mar2021 12:45 pm at single dose for COVID-19 immunization. The patient's medical history included juvenile rheumatoid arthritis, asthma, diabetic Type 2, neurological seizure disorder from traumatic brain injury. The patient had known allergies to penicillin, tetracycline, sulfonamide. Concomitant medications included methotrexate (withheld for 2 weeks 25mg injection). On 28Mar2021 1:15 AM, the patient experienced neurological grand mal seizures, sore achy bones, muscle, tight chest, and difficulty breathing. The patient was treated with nebulizer for difficulty breathing. It was reported that patient had no covid prior vaccination nor tested post vaccination. Outcome of events was reported as not recovered.
54 2021-04-14 platelet count decreased, haemoglobin decreased Pfizer-BioNTech COVID-19 Vaccine EUA: three days after vaccination patient reports nausea, vomiting,... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA: three days after vaccination patient reports nausea, vomiting, and abdominal cramping, Presents to oncology clinic with fever (temp 38.5 Celsius), rigors, and chills. Patient admitted to oncology service for fever and rigors while on immunosuppression.
54 2021-04-14 heart rate increased, fast heart rate Systemic: Allergic: Anaphylaxis-Medium, Systemic: Shakiness-Mild, Systemic: Tachycardia-Medium, Addi... Read more
Systemic: Allergic: Anaphylaxis-Medium, Systemic: Shakiness-Mild, Systemic: Tachycardia-Medium, Additional Details: temp within normal range, BP 149, 146, then 161. had a fast heartbeat so drink 2 small water bottle and shaking hands a liitle.\r\npharmay monitored her more than 1 hour and 30 minutes. she is ok to go home. (previous event happened on last december d/t epinephrine inj at dental office)
54 2021-04-17 heart rate increased, chest pain my chest hurt; I started coughing all of a sudden.; My heart started raising.; I had to lay on my st... Read more
my chest hurt; I started coughing all of a sudden.; My heart started raising.; I had to lay on my stomach to relieve the pressure and pain in my chest.; I was having troubling breathing; This is a spontaneous report received from a contactable consumer (patient). A 54-year-old female patient received the second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 30Mar2021 at 18:30 (Batch/Lot Number: ER8727) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose (lot number: 6207) of the same vaccine on 09Mar2021 at 06:30 am in left arm for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient reported that she had the second dose at 6:30 p.m. By 10:30 a.m. the next day she started coughing all of a sudden. Needed to take an inhaler to some what calm it down. Her heart started raising. That evening she had to lay on her stomach to relieve the pressure and pain in her chest. The following day went to the doctor because her heart was raising so much that she was having troubling breathing and her chest hurt. They did an EKG it was concerning of how fast her heart was beating. That same day the patient was sent to a cardiologist. Her heart was still raising and they did a EKG and the beats were about average. So then she had an Cardio gram and that was normal. The next day the doctor called and gave her the ECO reports and the cardiologist believed it was from the vaccine. The onset date of all adverse events was reported as on 31Mar2021 at 10:30AM. All events were reported as non-serious by reporter. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive treatment for the events. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. The patient was not pregnant at the time of vaccination. The outcome of all the events was unknown.
54 2021-04-18 cerebrovascular accident Stroke symptoms; Facial drooping; weakness in legs; difficulty walking; speech difficulty; loss of u... Read more
Stroke symptoms; Facial drooping; weakness in legs; difficulty walking; speech difficulty; loss of use of left arm; rash on hands; This is a spontaneous report from a contactable consumer (patient herself). A 54-year-old female patient received BNT162B2(Pfizer-BioNTech COVID-19 mRNA vaccine), dose 2 via an unspecified route of administration, at age 54 years, administered in the right arm on 10Mar2021 11:15 (Batch/Lot Number: EN6199) as single dose for COVID-19 immunization. Relevant medical history include Hashimoto's thyroiditis from an unspecified date, allergies to shellfish and tree nuts. Patient is not pregnant. Patient did not have COVID prior to vaccination. Concomitant medication include levothyroxine sodium (SYNTHROID). No other vaccines administered in four weeks. Patient previously took amoxicillin and cefalexin and experienced allergies. The patient historically took first dose of BNT162B2 (lot number: EM9810) at age 53 years on 17Feb2021 at 10:45 AM on the right arm for COVID-19 immunization. On 13Mar2021 at 19:45, evening, patient experienced stroke symptoms, facial drooping ,weakness in legs, difficulty walking, speech difficulty, loss of use of left arm, rash on hands. Treatment for the events was TPA. The patient was hospitalized for 4 days. COVID was not tested post-vaccination. Vaccination facility type was at a public health department. The outcome of the events was recovered on an unspecified date.
54 2021-04-20 blood clot Extreme inflammatory response. In ER/hospitalized 5 days post vaccine; Had Angiogram, found clot in... Read more
Extreme inflammatory response. In ER/hospitalized 5 days post vaccine; Had Angiogram, found clot in Obtuse Marginal; This is a spontaneous report from a contactable consumer (patient). A 54-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 21Mar2021 12:00 (Lot Number: EN6207), age at vaccination of 54-years-old, as single dose for covid-19 immunisation. Medical history included cardiac failure from an unknown date and unknown if ongoing, connective tissue disorder from an unknown date and unknown if ongoing. Patient was not pregnant. Concomitant medications included hydroxychloroquine sulfate (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]) taken for an unspecified indication, start and stop date were not reported; isosorbide mononitrate (IMDUR) taken for an unspecified indication, start and stop date were not reported; metoprolol (METOPROLOL) taken for an unspecified indication, start and stop date were not reported; rosuvastatin calcium (CRESTOR) taken for an unspecified indication, start and stop date were not reported; furosemide (FUROSEMIDE) taken for an unspecified indication, start and stop date were not reported. The patient previously took codeine and experienced hypersensitivity. The patient experienced extreme inflammatory reaction on 24Mar2021 at 04:00 AM and clot blood on 24Mar2021; events were serious as resulted in Emergency room/department or urgent care, hospitalization (for 5 days), life threatening illness (immediate risk of death from the event). The patient had extreme inflammatory response; in ER/hospitalized 5 days post vaccine. Angiogram was performed and clot in obtuse marginal was found; unable to remove clot, surgeon was able to break it apart and balloon the vessel open. It was unknown if patient had COVID prior vaccination. Patient had no other vaccine in four weeks. Sars-cov-2 test was negative on 15Apr2021. The patient was considered to be recovering from the events.
54 2021-04-24 heart rate increased, hypertension fast HB; Severe head ache; abdominal cramps; extremely high BP; This is a spontaneous report from a ... Read more
fast HB; Severe head ache; abdominal cramps; extremely high BP; This is a spontaneous report from a contactable consumer(patient). This 54-year-old female patient (not pregnant) received 2nd doe of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EN6204) at single dose via an unwon route in right arm on 26Mar2021 02:15PM for Covid-19 immunization. Medical history included hypothyroidism. Patient had no known allergies. Other medications in two weeks included levothyroxine and meloxicam. Patient did not have COVID prior vaccination. Historical vaccine included 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EN6198) on 26Feb2021 in right arm for Covid-19 immunization. Patient experienced severe headache, abdominal cramps, extremely high blood pressure (BP) and fast heartbeats (HB), which was ongoing for 3 weeks as of 06Apr2021. The events onset date was 30Mar2021 08:00AM. The events resulted in Emergency room/department or urgent care. Treatment included IV fluids and BP medications. Lab data included CT scans and blood/ urine tests. The events were reported as serious with seriousness criteria of medially significant and life-threatening illness (immediate risk of death from the event). Outcome of the event was not resolved. Patient did not test for COVID post vaccination.
54 2021-04-24 loss of consciousness, chest pain pass out; sharp pain on the left side of her chest that continually got worse; it seemed muscle or l... Read more
pass out; sharp pain on the left side of her chest that continually got worse; it seemed muscle or lymph node related; This is a spontaneous report from a contactable consumer (patient) reported that a 54-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ep6955), via an unspecified route of administration, administered in arm left on 23Mar2021 15:45 (at the age of 54-years-old) as a single dose for covid-19 immunisation. The vaccine was administered at the Pharmacy/drug store. The patient was not pregnant at the time of vaccination. The patient medical history included Hashimoto's from an unknown date. The patient had known allergies to shellfish. The patient had no covid prior vaccination. Concomitant medications included levothyroxine sodium (SYNTHROID); vitamin c [ascorbic acid] (VITAMIN C); colecalciferol (VITAMIN D); cyanocobalamin (B 12); magnesium; and cetirizine hydrochloride (ZYRTEC); all were taken for an unspecified indication, start and stop date were not reported. On 23Mar2021 16:30 45-minutes after getting the shot the patient had a sharp pain on the left side of her chest that continually got worse. It seemed muscle or lymph node related - and eventually got to the point where she couldn't easily move without feeling like she was going to pass out from the pain. The events resulted in doctor or other healthcare professional office/clinic visit. The patient received treatment for the events included prescription pain reliever and muscle relaxant. The outcome of the events was recovered. The patient did not covid tested post vaccination.
54 2021-04-24 loss of consciousness passed out; trouble flexing her right hand open and closed; not feeling well, she feels very bad; so... Read more
passed out; trouble flexing her right hand open and closed; not feeling well, she feels very bad; sores in her mouth and nose; sores in her mouth and nose; anal hemorrhoid sores; had difficulty speaking, with her words; has been dropping things, she has broken glass; her eye felt heavy and her eye was drooping; Dizzy; Fall; Slight fever; Fatigue; extreme pain through right side (right side means her shoulders, neck, torso, arm, and entire leg); first dose given 14Jan2021, and second dose given 07Mar2021; first dose given 14Jan2021, and second dose given 07Mar2021; Shortness of breath; severe nerve pain; Vomiting; had a feeling of urination, like she had to urinate when she didn't, that feeling of urination; Disorientated; eye pain like pins and needles; skin is burning and painful to the touch; Headache; joint and muscle pain; joint and muscle pain; Nausea; horrible lack of appetite/couldn't eat anything other than soup; This is a spontaneous report received from a contactable consumer (patient) via a Pfizer-sponsored program called COVAX US Support. A 54-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 07Mar2021 (Lot Number: EN6204) as single dose for covid-19 immunization. The patient's medical history included history of three spinal surgeries (takes no pain meds, she is not on pain meds, she has never been on or kept taking them); and has "neuropathy and nerve related issues" that were not this bad since ten years ago in 2011, clarified that what she has is not actually neuropathy, something with the peripheral nerve, she says she doesn't remember actual verbiage), since ten years ago in 2011, and the only difference was this vaccination, it was not this bad until this vaccination. She doesn't react well to pharmaceuticals anyway (unspecified). Her medications are that she takes the minimum amount of medications, very minimal (unspecified). There were no concomitant medications. There was no other products. Also, she has not had any other recent vaccinations or started any new medications. For past drug, she didn't take anything other than 5mg of zolpidem tartrate (AMBIEN) to sleep at night because of her spine. Patient previously also took pregabalin (LYRICA) and was off it, was also on gabapentin or neurontin (patient did not have those medications to provide NDC/LOT/EXP for either of them because she took them back to the pharmacy or turned them in to the police station because she doesn't keep medications in her house if she isn't taking them, and she couldn't take that medication). Historical vaccine included first dose of bnt162b2 on 14Jan2021 (at the age of 54-year-old; Lot Number: EN5318) in Arm Right for covid-19 immunization, and for her first dose the only thing was a sore arm, it was very sore, and she only experienced a slight bit of fatigue after her first dose. She received both doses of vaccine. Her first dose was LOT: EN5318 and was given 14Jan2021, and her second dose was LOT: EN6204 given 07Mar2021. The patient was reporting for Pfizer COVID-19 vaccine, for she was having a horrible reaction to it "45 days" (as reported) after taking 2nd dose, and had been in the ER, and her temperature still hasn't gone back down to her normal, her oral temp is still raised and her rectal is raised even more. She was not feeling well, she felt very bad, she would never get a vaccine again, that is how bad it was. Since "45 days" later she was still having significant pain and trouble flexing her right hand open and closed. For events treatment, she took over the counter Tylenol for fever and pain, strength unknown. Patient said she had not had this kind of disabling symptoms or anything before this vaccination. She had a slight fever almost the whole "45 days". On 08Mar2021, her oral temp was over 98 degrees Fahrenheit when her norm temp being 97.2 or 97.3degrees Fahrenheit. Her rectal temp stayed at 100 degrees Fahrenheit. The next day, actually on the 09Mar2021 (which was two days after her second dose), she had the slight fever, fatigue, and extreme pain through her right side. She said her right side means her shoulders, neck, torso, arm, and entire leg. She also had shortness of breath, and severe nerve pain. She called her primary care provider who said to wait 5 days to be seen. On day 5, or actually the whole five days (reported as in Mar2021), she was in bed and didn't leave her apartment because she was in bed and she was vomiting. On day 2 or within 6 hours of vaccination, she had a feeling of urination, like she had to urinate when she didn't, that feeling of urination was equivalent of having contrast dye (NDC/LOT/EXP: Unknown) put in her IV which makes her feel like she is peeing her pants but she did not, and that feeling has not gone away. On day 5 (11Mar2021), she was dizzy and fell. In Mar2021, she was disorientated and vomiting, she couldn't eat anything other than soup. On day two (Mar2021) she had some kind of eye pain that is still there "45 days later", it feels like pins and needles. Her skin was burning and painful to the touch, she couldn't keep an IV in her when she was in the ER. She was not admitted to the hospital. She was having headaches, and joint and muscle pain. She had nausea and vomiting at different times. She continued to have shortness of breath. She had a horrible lack of appetite. She had sores in her mouth and nose. She had anal hemorrhoid sores. Last night (05Apr2021 )she had a headache that was severe like someone put a knife behind her right eye, and when she got up (06Apr2021) her eye felt heavy and her eye was drooping. She also had difficulty speaking, with her words. She says she had passed out, and had been dropping things, she had broken glass. She has been to a neurologist and a gastroenterologist. She clarified that all of these events were after her second dose, for her first dose the only thing was a sore arm, it was very sore, and she only experienced a slight bit of fatigue after her first dose. None of her doctors know what to do, her gastro doctor was giving her an anti inflammatory suppository and was going to do some tests. She had blood done from neurologist and at the ER and no one knows what to do, they keep referring her to other doctors. She wished someone could explain to her, but no one know and they said it was uncharted territory, they didn't know what to do. She is now back on Lyrica which she was off of but the ER prescribed her 300mg three times a day. She wanted to know what the hell is going on with this vaccine, and that she doesn't think having these side effects "45 days" out is normal. She wanted to be transferred to speak with someone about what to do because her doctor's don't know anything. The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.
54 2021-04-24 blood pressure increased, chest pain severe chest pain like severe heart burn attack/the doctors do not think it is heart burn/radiating ... Read more
severe chest pain like severe heart burn attack/the doctors do not think it is heart burn/radiating pain into the right arm and lymp nodes; blood pressure was through the rood; severe pain; cardiac issues; GI issues/GI malfunction of the pancreas and gallbladder; GI issues/GI malfunction of the pancreas and gallbladder; can not eat, work, or engage in daily activities/She is unable to eat and is very weak; can not eat, work, or engage in daily activities/She is unable to eat and is very weak; can not eat, work, or engage in daily activities; nausea; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received the 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16Mar2021 09:45 (Batch/Lot Number: Unknown reported as either EN6205 or EM6205) as SINGLE DOSE for COVID-19 immunization; azithromycin (ZITHROMAX), via an unspecified route of administration from 26Feb2021 until 02Mar2021, at unspecified dose and frequency for dental care; and corticosteroid (CORTICOSTEROID), via an unspecified route of administration from an unspecified date with last dose shot on 23Mar2021 at unknown dose, once or twice a year for a couple of years for knee pain and joint pain . Medical history included dental procedure on an unknown date. Concomitant medications were not reported. On 25Mar2021 (9 days later), she developed severe chest pain like severe heart burn attack radiating pain into the right arm and lymph nodes, blood pressure was through the roof and was in severe pain. She was unable to eat, was very weak and also cannot work or engage in daily activities noted in Mar2021. The patient required emergency room and physician office visit due the events (including cardiac issue and GI issues/malfunction of the pancreas and gallbladder). She was hospitalized on 03Apr2021 and was just released on 04Apr2021. During hospitalization, doctors have ruled out cardiac issue and GI issues/malfunction of the pancreas and gallbladder and they cannot find out the cause. The patient received famotidine (PEPCID), omeprazole (PRILOSEC), pantoprazole (PROTONIX), acetaminophen (TYLENOL) as treatment. While in the hospital they gave her dicycloverine (BENTYL) which she thought was for nausea noted in 2021.She stated a week after she got the vaccine she got a corticosteroid shot which she was wondering if it can impact one's immune system and cause an adverse reaction with the vaccine. She also stated that a month prior to vaccine she took an azithromycin. She also was wondering with the combination of all these three things being close together if it may have caused a disruption in her body organic system. The action taken in response with the adverse event for azithromycin was post therapy while unknown for corticosteroid shot. The patient did not recover from chest pain while outcome of the remaining events were unknown. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : PFIZER INC-2021376222 Pfizer
54 2021-04-27 chest discomfort Felt funny in her chest, like a really weird, really warm and heavy feeling, almost like she couldn'... Read more
Felt funny in her chest, like a really weird, really warm and heavy feeling, almost like she couldn't breathe; almost like she couldn't breathe/Difficulty Breathing; Felt funny in her chest, like a really weird, really warm and heavy feeling/ warm feeling in the chest; having an anaphylactic reaction from the vaccine; Respiratory, Wheezing, Difficulty Breathing and Respiratory Distress; Respiratory, Wheezing, Difficulty Breathing and Respiratory Distress; Very sore right arm where she was given the injection; felt like she was punched several times in her arm; Injection site bruising; This is a spontaneous report from a contactable nurse(patient). The nurse reported similar events for herself and her husband. This is the first of two reports. A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 54 years of age), dose 1 intramuscular, administered in arm right on 10Mar2021 16:00 (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. Medical history included severe asthma which started as a child and then it went away and then as an adult it got severe around 2010 and ongoing, she was an asthmatic and would panic and start feeling worse. She had ongoing chronic obstructive pulmonary disease (COPD), brain surgery in 2007, low immune system, allergies to cephalosporins, pulmonary and stomach issues; and bradycardia (as her BP usually runs 90/45 and she is bradycardic). Concomitant medications included tiotropium bromide (SPIRIVA RESPIMAT), salbutamol sulfate (PROAIR HFA), fluticasone propionate, salmeterol xinafoate (ADVAIR HFA), salbutamol (VENTOLIN [SALBUTAMOL]), and montelukast (MONTELUKAST), all taken for asthma, chronic obstructive pulmonary disease from an unspecified start date and ongoing; clarithromycin (CLARITIN [CLARITHROMYCIN], omeprazole, phenytoin sodium, azelastine, ipratropium bromide, fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]), and ipratropium bromide, salbutamol sulfate (DUONEB), all taken for an unspecified indication from an unspecified start date and ongoing; prednisone taken for an unspecified indication from 2021 and ongoing as she was on this steroid 2 weeks before the vaccine; and azithromycin which she takes prophylactically for her low immune system from an unspecified start date and ongoing. She was on a lot of medications period and most are for her pulmonary and stomach issues. The patient previously took propofol, Versed, Nitrous Oxide, and Percocet wherein the patient had drug hypersensitivity and anaphylactic shock with these; adhesive from nicotine patch made her arm to get red and swollen (Dermatitis contact). She previously took EpiPen for anaphylaxis. It was reported that on 10Mar2021, the patient had the first dose of the vaccine and it felt funny in her chest, like a really weird, really warm and heavy feeling, almost like she couldn't breathe. She got her vaccine at a hospital in their clinic and she was transferred from the vaccine clinic to the ER. Stated she was given a shot with an Epi-pen in her thigh at the clinic and transferred to the ER. In the ER, she was given Benadryl and watched for 4 hours. She would state this was medically significant because of airway, breathing, circulation and she felt like she couldn't breathe. She added that it was kind of weird and freaky. She mentioned that along with that, shortly before she was released from the ER, she experienced a very sore arm where she was given the injection. She heard that was very common so she dealt with it. However as the night progressed, it got increasingly worse, it almost felt like she was punched several times in her arm. It probably started between hour 3 and 4 after receiving the vaccine. She added that she had a very sore right arm where she was given the injection; felt like she was punched several times in her arm. It was not serious, just annoying and it was gone 3 days later. She had injection site bruising on 10Mar2021. She stated that she knows this because she was a nurse, but a lot of times, people experienced this reaction when they are given Dilaudid wherein they get a warm feeling in their chest, so they push it really slow and dilute it with saline so it doesn't have the respiratory factor. She stated that this was kind of what the feeling was like for her and it was scary because she didn't expect it. She stated that the ER team that assessed her said, because she wasn't used to that feeling, she may have had a panic attack and that may have made it worse. After she was treated, she spoke with her husband and he had the shot two minutes before her and he had the same feeling but he didn't freak out and didn't want to appear weak. Stated he told her he had the same feeling and it lasted 5 minutes and then it went away. Stated since she got scared, it made it worse. She doesn't know if she had a panic attack that made it worse. She stated that of course her husband didn't tell her that until she was out of the ER, that it does go away. That made her feel better because she wasn't the only one that experienced that. States he didn't say anything about it, because he was worried about her, he said it was a warm feeling in the chest and not being able to breathe but he didn't want to say anything because she was an asthmatic and would panic and start feeling worse. She mentioned that they weren't going to let her get the second dose, so she went to an allergy doctor and told them what happened and about her husband having the same reaction and because she was severely immunocompromised. Stated the hospital said they were not giving her the second dose unless an allergist says it is safe and sets a protocol and he had to write a letter to the hospital. Stated she was pre-medicated 24 hours before the vaccine with 50mg Benadryl, 50mg Benadryl the day of the shot and 50mg of Benadryl two days after the shot. Stated she will have full immunity on 14Apr2021. She added that she had a pulmonary doctor, brain cancer doctor, ENT doctor, stated they don't know if it was caused by the vaccine, but they are pretty sure she had a reaction but they can handle it with pre-medicating her. She received the second vaccine on 31Mar2021. She mentioned that she was happy to be able to get her second shot. She stated that at first they didn't want to give it to her because of her reaction but she kept calling. So she went to a hospital to saw an allergist and he had to sign off that it was safe to give her the second shot and under what circumstances. Stated she had the letter from the hospital that she was seen by them and she needed to be pre-medicated and it had to be given at a hospital that had the ability to intervene quickly and she needed to be watched for at least 30 minutes after the vaccine. She mentioned that to go through what she went though, and not be able to get would have been disappointing. Because of her immune system, it is important to get the shot and there was a way around the reaction which worked for her. She added that even having an anaphylactic reaction from the vaccine, she was able to recover quickly. Stated with having asthma, COPD and a low immune system, she may not recover from Covid. It makes sense they evaluated it and came up with a solution and a pre medication protocol and when and how long and she was still able to get the shot because it is important. Answers to follow up questions indicated that on 10Mar2021, the patient had the first dose of the vaccine and it felt funny in her chest, like a really weird, really warm and heavy feeling, almost like she couldn't breathe. She was given the shot and getting ready to get out of the chair and her husband was about to sit down for his shot. Stated she would say the time of the course of the reaction was within under 5 minutes of her injection. The patient required medical intervention with Epi-Pen, Benadryl, and Duo-Neb. The patient was not hospitalized because she was immunocompromised, it was better to watch herself at home and because she had an Epi Pen at home in case she has that sort of reaction returning over a 72 hour period. Stated they instructed her husband and told them if she felt any different to come back to ER. She was not admitted to the ICU. Organ involvement included: Respiratory, Wheezing, Difficulty Breathing and Respiratory Distress. The event required initiation of new medication or other treatment or procedure including Epi-Pen, Benadryl, DuoNeb. Patient have a history of previous allergies: Medication Allergies to Cephalosporins, Anesthesia medications: Propofol, Versed, Nitrous Oxide, Percocet: Anaphylactic shock; Adhesive from nicotine patch, caused her arm to get red and swollen. She takes EpiPen as she had previous history of allergies and since she had multiple medication allergies and had a history of quickly going into anaphylaxis, stated her BP usually runs 90/45 and she was Bradycardic. She did not receive any recent vaccines for any other conditions prior to the events being reported. She did not receive any recent vaccines for SARS-CoV2 other than Pfizer-BioNTech COVID-19 Vaccine prior to the event being reported. She has not received any other vaccines around the time of the Pfizer-BioNTech COVID-19 Vaccine vaccination. The patient recovered from 'felt funny in her chest, like a really weird, really warm and heavy feeling, almost like she couldn't breathe', Difficulty breathing, and 'warm feeling in the chest' on 10Mar2021; while having an anaphylactic reaction from the vaccine, Respiratory, Wheezing, Difficulty Breathing and Respiratory Distress were recovered on an unknown date; Vaccination site pain recovered on 13Mar2021 and Injection site bruising recovered on 18Mar2021. Therapeutic measures were taken as a result of all events except Vaccination site pain and Injection site bruising. Relatedness of drug to reactions/events: Reaction assessed for events "felt funny in her chest, like a really weird, really warm and heavy feeling, almost like she couldn't breathe", 'very sore right arm where she was given the injection; felt like she was punched several times in her arm.' and Injection site bruising: Method of assessment: Global Introspection: Drug result: Related. Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, the Company considered all serious and non-serious events as possibly associated to BNT162B2 injection, due to a plausible chronological sequence. Current patient conditions of asthma, chronic obstructive pulmonary disease and allergic diathesis may have been considered as favoring factors in development of reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate,Linked Report(s) : US-PFIZER INC-2021406773 same reporter and drug, similar events, different patient
55 2021-01-01 palpitations Employee developed some anxiety, heart racing and tingling in her lips. this resolved on its own af... Read more
Employee developed some anxiety, heart racing and tingling in her lips. this resolved on its own after 10 minutes.
55 2021-01-01 chest pain Employee states pain in left shoulder down into chest and lightheadedness but the symptoms resolved ... Read more
Employee states pain in left shoulder down into chest and lightheadedness but the symptoms resolved within 15 minutes.
55 2021-01-03 fainting, fast heart rate 5 days after 1st vaccine, experienced sync opal event at home. .Arrived at work 12/28/2020 feeling s... Read more
5 days after 1st vaccine, experienced sync opal event at home. .Arrived at work 12/28/2020 feeling slightly lightheaded and tachy. went home.
55 2021-01-03 chest pain Dec. 29: she developed arm soreness and joint pain. Dec. 30: she developed pain in chest area radi... Read more
Dec. 29: she developed arm soreness and joint pain. Dec. 30: she developed pain in chest area radiating towards the back Jan. 01: she noticed a rash in the mid abdomen radiating towards the back. She has been experiencing pain in the affected area.
55 2021-01-04 hypotension Agitation, Sedation, Anaphylaxis, Rash & HYPOtension
55 2021-01-04 heart rate increased Rapid heart beat- 2 brief instances within 15-20 minutes of vaccine administration; Light headed fee... Read more
Rapid heart beat- 2 brief instances within 15-20 minutes of vaccine administration; Light headed feeling; This is a spontaneous report from a non-contactable consumer (patient). A 55-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration on left arm on 23Dec2020 07:30 at single dose for COVID-19 immunization. Medical history included high blood pressure (HBP), supraventricular tachycardia (h/o SVT), h/o breast cancer, and sulfa drugs allergies. The patient was not pregnant. Concomitant medication included famotidine, metoprolol succinate, and tamoxifen. The patient experienced lightheaded feeling and rapid heartbeat- 2 brief instances within 15-20 minutes of vaccine administration on 23Dec2020. No treatment was received for the events. Facility where the most recent COVID-19 vaccine was administered was at a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and has been tested for COVID-19 since the vaccination via nasal swab on 24Dec2020, results was pending. The outcome of the events was recovered. No follow-up attempts are possible. No further information is expected.
55 2021-01-05 chest discomfort 5 minutes after receiving Covid-19 vaccination patient reacted with chest tightness and was very lig... Read more
5 minutes after receiving Covid-19 vaccination patient reacted with chest tightness and was very lightheaded. Patient has a history of anaphylaxis and had Epi Pens with her. 1600 Vitals: BP: 184/72 P: 117 SaO2: 100% Epi Pen self-administered. 1605 Vitals: BP: 125/74 P:103 SaO2: 100% Nurse transferred patient to ER in wheelchair for further treatment and evaluation.
55 2021-01-05 lightheadedness Patient was very nervous prior to vaccination, and immediately after the injection, she developed va... Read more
Patient was very nervous prior to vaccination, and immediately after the injection, she developed vasovagal reaction. It took her at least 30 minutes to recover, but was stable and went home with spouse.
55 2021-01-05 lightheadedness Patient was very nervous prior to vaccination, and immediately after the injection, she had a vasova... Read more
Patient was very nervous prior to vaccination, and immediately after the injection, she had a vasovagal reaction. It took her at least 30 minutes to recover, but was able to go home with spouse.
55 2021-01-05 chest pain, fast heart rate Rash, chest pain, tachycardia, numb tongue, hard to swallow
55 2021-01-05 fainting Syncopal episode went to ER and required stitches
55 2021-01-05 chest discomfort Temperature, cough, chest pressure, fatigue, redness and bump at immunization site
55 2021-01-05 hypertension Wave of coolness reported. Lightheadedness that resolved 10 minutes post vaccine. Blood pressure wa... Read more
Wave of coolness reported. Lightheadedness that resolved 10 minutes post vaccine. Blood pressure was high on taking 183/91. Patient reports History of "White Coat Hypertension". Symptoms resolved. MOnitored for at least 15 minutes and released to home. Recommended patient follow-up with PCP regarding potential underlying hypertension..
55 2021-01-06 fast heart rate Headache, Fever, Tachycardia, rigor, lightheaded, back ache, BP 80/50, admitted to ER for observatio... Read more
Headache, Fever, Tachycardia, rigor, lightheaded, back ache, BP 80/50, admitted to ER for observation from 11 am to 5 pm
55 2021-01-06 fainting, palpitations Headache, Myalgia, CoughWheeze, NauseaVomiting, Palpitations, Syncope, Arm pain, chills and overall ... Read more
Headache, Myalgia, CoughWheeze, NauseaVomiting, Palpitations, Syncope, Arm pain, chills and overall weakness Narrative: Employee was unable to work second to symptoms, missing >1 days of work at time of this report.
55 2021-01-06 chest pain, palpitations Patient complained of palpitations 30 minutes after receiving the COVID19 vaccine. She had this same... Read more
Patient complained of palpitations 30 minutes after receiving the COVID19 vaccine. She had this same reaction after the first dose. She felt her heart racing and throat closing with chest pain. She received diphenhydramine 25 mg IV, famotidine 20 mg IV, and methylprednisolone 80 mg IV.
55 2021-01-06 palpitations, chest discomfort Pharmacist noticed the patient trying to clear her throat and she said she thinks she just needed a ... Read more
Pharmacist noticed the patient trying to clear her throat and she said she thinks she just needed a drink. When the drink did not help she was given 12.5mg of diphenhydramine at 4:57pm. It was recommended and offered for her to take 25mg of diphenhydramine but patient stated it made her too drowsy. After a few minutes, the patient stated it felt like her throat was tightening so she was given the other 12.5mg of diphenhydramine given at 5:03pm. She stated her heart was racing and her head was pounding. Her blood pressure was 164/72 and pulse 117. She stated her chest was feeling tight and at 5:11 an EpiPen was administered and call to 911.
55 2021-01-06 blood pressure increased, palpitations Vaccine administered at 11:15 AM. At 12:00 pm the top of my head became very hot, my face felt hot ... Read more
Vaccine administered at 11:15 AM. At 12:00 pm the top of my head became very hot, my face felt hot and red with raised rash, my scalp became very itchy, my heart felt like it was beating out of my chest and I had pounding in both ears. My bilateral forearms began to itch and then developed hives. I notified my Supervisor that I was having a reaction. I was checked in to ER (where I am an RN). My blood pressure was elevated 180's systolic and my heart rate was 180BPM and short of breath. An IV was started and I was given Normal Saline Bolus, Solu-medrol 125MG and Benadryl 25MG IV. Prior to medications, my throat felt itchy and "tight" but resolved once medication given. The itching and hives continued to spread to my upper back, neck, bilateral feet and behind my bilateral knees. After approximately 1 1/2 hrs itching and hives continued then I was given Pepcid IV and Benadryl 25mg PO which after 40 minutes my itching and hives resolved. I was later discharged home with a prescription of Methylprednisolone 4MG dose pack. Symptoms resolved until approximately 1:30 am on 5/7/2021 when I awoke to pounding in my ears and the feeling once again my heart was beating out of my chest. My heart rate was 132BPM, I became hot and diaphoretic, short of breath. My scalp felt it was on fire and then I broke out in hives. I immediately took Prednisone, benadryl and pepcid. I took a cool shower, got dressed and drove to the hospital down the road and sat in the parking lot just in case my throat became itchy and tight (which it did not). The hives and itching began to resolve after an hour. My heart rate went back to 67BPM and shortness of breath resolved as well. I called Employee Health at hospital and made a report of symptoms.
55 2021-01-07 heart rate increased Flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling,... Read more
Flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling, eyes felt like pinpoints, hives on neck, sweating. Started after 5 minutes.; Flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling, eyes felt like pinpoints, hives on neck, sweating. Started after 5 minutes.; Flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling, eyes felt like pinpoints, hives on neck, sweating. Started after 5 minutes.; Flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling, eyes felt like pinpoints, hives on neck, sweating. Started after 5 minutes.; Flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling, eyes felt like pinpoints, hives on neck, sweating. Started after 5 minutes.; Flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling, eyes felt like pinpoints, hives on neck, sweating. Started after 5 minutes.; Flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling, eyes felt like pinpoints, hives on neck, sweating. Started after 5 minutes.; Flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling, eyes felt like pinpoints, hives on neck, sweating. Started after 5 minutes.; hives on neck; This is a spontaneous report from a contactable health care professional nurse, the patient. A 55-years-old non-pregnant female patient (nurse) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EH9844), intramuscular in the left arm on 20Dec2020 13:45 as a single dose, Lot number EK5730 for COVID-19 vaccination. Medical history included ongoing complex regional pain syndrome. The patient previously took Ceftiaxone, tizanidine, vancomycin, triamcinone, duloxetine and experienced drug hypersensitivity. Concomitant medication were taken within two weeks but details not provided. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 20Dec2020 14:00 the patient experienced flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling, eyes felt like pinpoints, hives on neck, sweating. Started after 5 minutes. No treatment was given for the events. The clinical outcome Flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling, eyes felt like pinpoints, hives on neck, sweating was recovered.
55 2021-01-07 excessive bleeding Swelling, bleeding, and warmth immediately after administration. 1/7/21, she broke out in hives and ... Read more
Swelling, bleeding, and warmth immediately after administration. 1/7/21, she broke out in hives and had general body aches, which has continued into 1/8/21.
55 2021-01-07 fast heart rate within 5 minutes became lightheaded, flushed, tachycardia , itching in both hands Given Benadryl ... Read more
within 5 minutes became lightheaded, flushed, tachycardia , itching in both hands Given Benadryl 25 mg , Pepcid , solu-medrol
55 2021-01-08 blood pressure increased SkinRash Vaccinated with 2nd dose @ 0942 w/o issue. After she returned to work, c/o rash to chest an... Read more
SkinRash Vaccinated with 2nd dose @ 0942 w/o issue. After she returned to work, c/o rash to chest and arms. At 1500 returned to the immunization clinic. Take to ED for evaluation BP 224/108, 88, 18, 97% O2sat. Narrative: Vaccinated with 2nd dose @0942 w/o issue. 5 hours later at 1500 returned to the immunization clinic with c/o rash to chest and arms and c/o slight H/A. BP elevated. Taken to ED for evaluation BP 224/108, 88, 18, 97% O2sat.
55 2021-01-10 chest discomfort Patient experienced throat tightness, chest tightness, anxiety, and lightheadedness that did not sub... Read more
Patient experienced throat tightness, chest tightness, anxiety, and lightheadedness that did not subside after 30 minute observation. She was transferred to the ED for further evaluation.
55 2021-01-10 chest discomfort Patient experienced throat tightness, chest tightness, lightheadedness, and anxiety which did not su... Read more
Patient experienced throat tightness, chest tightness, lightheadedness, and anxiety which did not subside after 30 minutes of observation. She was transferred to the ED for further evaluation.
55 2021-01-10 palpitations Shortly after administration of the vaccine on 1/7/21, the patient experienced heart palpitations. ... Read more
Shortly after administration of the vaccine on 1/7/21, the patient experienced heart palpitations. Continued all day and into the next day. The patient contacted PCP on 1/8/21. PCP indicated since a recent stress test was done (12/1/20), no need for an EKG. Per patient, PCP thinks the patient has acid reflux (actively taking omeprazole 20mg/day). Palpitations have resolved.
55 2021-01-11 heart rate increased PATIENT BECAME DIZZY AND ELEVATED HEART RATE (120) PATIENT OBSERVED AN EXTRA 15 MINS PATIENT SYMTOM... Read more
PATIENT BECAME DIZZY AND ELEVATED HEART RATE (120) PATIENT OBSERVED AN EXTRA 15 MINS PATIENT SYMTOMS RESOLVED
55 2021-01-12 chest discomfort 12/23/20 @2320---left arm pain started with progression to antecubital and axilla and back of neck.... Read more
12/23/20 @2320---left arm pain started with progression to antecubital and axilla and back of neck. 12/24/20 @ 0600 vomited x 2. Headache, runny nose, fatigue, general achiness---became worse as the day progress to include both hips and knees becoming painful. Shortness of breath with pulse ox levels of 91-97% on room air. Heart rate 104-124 bpm for 9 hours, Chest discomfort, cough, achy fingers, mild hand tremors, flushed face, nausea, decreased appetite, fatigue, chills . 12/25/20 @ 0120--severe muscle and joint pain---self medicated with 1000mg acetaminophen, stomach pain---used digestzen. tossed and turned until after 0428. 0920--increased area of painful lymph nodes: left arm axilla, breast and back of neck. Fatigue continues---although less than the day before 12/26/20 through 12/28/20 symptoms continue to decrease. 12/29/20----woke up feeling great. Took the stairs at work---no shortness of breath. At work received the mail out Covid test-----results were positive ( no symptoms of covid)
55 2021-01-12 fainting Systemic: Fainting-Medium
55 2021-01-12 chest discomfort chest tightness with shortness of breath; nausea for 10 minutes. Pain radiating to jaw
55 2021-01-12 fast heart rate headaches; tachycardia/fast heart beat; fever; body aches; joint pain/ joint ache; This is a spontan... Read more
headaches; tachycardia/fast heart beat; fever; body aches; joint pain/ joint ache; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK9231), via an unspecified route of administration on 06Jan2021 at single dose for work. The patient's medical history and concomitant medications were reported as none. The patient reported events of fever, headaches, body aches, joint pain, tachycardia, on 07Jan2021. Patient developed fever in the night, 100.5 at 1-3 am. Then, developed body ache and especially joint ache. She had a bad headache from 2-3 am. She also experienced a fast heart beat that started around 2-3 am. She received the vaccine at work. She started taking the paracetamol (TYLENOL) which did pushed down her fever. She thought it helped her headache as well and it helped her heart rate. Her headache was controlled with paracetamol. So she could not tell if it was improving, persisting, or worsening. Her heart rate at around 2-3 am was 115bpm, after paracetamol it got down to 105 bpm. Therapeutic measures were taken as result of the events included paracetamol (TYLENOL). The outcome of the events fever and tachycardia was recovering, outcome of event headaches was unknown, outcome of the other evets was not recovered. The report was reported as non-serious.
55 2021-01-13 chest discomfort I began to experience a dry throat about 10 minutes after injection - I attributed it to needing a d... Read more
I began to experience a dry throat about 10 minutes after injection - I attributed it to needing a drink. My throat then felt a bit warm and I thought this was due to thirst as well. I left the monitoring area. I was walking to my vehicle and began to feel more of a warm sensation in my throat and not into my upper chest. About 5 minutes after this took place my face became flush and began tingling and feeling sunburned and tight - I looked in the mirror and my cheeks and nose and chin were red and felt extremely warm - I did not have facial swelling that i noticed buy my face felt tingly and like it was sunburned - my eye felt puffy but did not look puffy enough to notice in the mirror. Approximately 30-35 minutes after the immunization, I took 50mg of Benadryl and 1300mg of Tylenol. I felt my symptoms begin to improve about 25-30 minutes after taking the medication - my throat and chest were not as warm. the facial flushing lasted about an hour or hour and a half. The morning after my immunization I did have a scratchy throat - I did not take any further medication - by the afternoon - this is almost gone - still just a little scratchy.
55 2021-01-13 chest pain Patient developed chest pain 5 minutes after vaccine administration. Patient was transferred to the ... Read more
Patient developed chest pain 5 minutes after vaccine administration. Patient was transferred to the EC and was given ASA, EKG (WNL), chest x-ray (negative) IV fluids and then DC home.
55 2021-01-13 heart rate increased, palpitations about an hour and a half after the injection I noticed my heart was beating very fast and hard. it ... Read more
about an hour and a half after the injection I noticed my heart was beating very fast and hard. it was waking me up at night due to the pounding. It has remained this way since i have had the injection on Dec 30, 2020.
55 2021-01-14 blood pressure decreased Patient became lightheaded at approximately 11:10 a.m. which was 9 minutes after administration of t... Read more
Patient became lightheaded at approximately 11:10 a.m. which was 9 minutes after administration of the vaccine. The patient had expressed some anxiety about receiving the vaccine but wanted to receive it. The patient complained of lightheadedness and we lowered her to the floor with feet elevated. Her blood pressure had lowered significantly (60/40 approximately). Patient began to feel better and sat back in her chair. She again began to complain of lightheadedness and was lowered to the floor with feet elevated once more. Patients stayed in this position for several minutes. When her blood pressure was rechecked, it had risen back to 118/78. Patient felt much better and also ate some crackers and drank some water. Patient's blood pressure was checked a final time in a seated position after approximately 20 minutes and her blood pressure was 118/82. Patient reported having an event like this 36 years ago after her first visit to an OB/GYN and was similarly nervous that day. Patient was counseled extensively on preventing future lightheadedness and signs of any vaccine related adverse event. After approximately 45 minutes of observation from the event, patient was driven home by her husband.
55 2021-01-15 pallor Rash on chest and abdomen appeared morning following injection. Appearance of sunburn, blanched when... Read more
Rash on chest and abdomen appeared morning following injection. Appearance of sunburn, blanched when touched, second day it was itchy, resolved totally day 4. Other symptoms included pressure headache which lasted one week. Fatigue and muscle achelasted 2-3 days.
55 2021-01-15 palpitations, chest pain The adverse events are side effect perhaps but extremely strong. Lightheadedness x 1.5 days, feelin... Read more
The adverse events are side effect perhaps but extremely strong. Lightheadedness x 1.5 days, feeling shaky and short of breath- afternoon of injection Significant headache x 48 hours (note: still having intermittent HA associated with 1st dose.) Significant arm pain (injection site)- 2 days Feeling shaky in legs- evening of injection Low grade fever x 48 hours, ongoing intermittently Waking at night several times- this does not happen to me. Waking overnight last night (AM of 1/16/21) with right hand numbness that lasted for some time. Extreme, extreme fatigue- the worst lasted 48 hours post vaccination. Still continuing but not as severe as the first 48 hours. Body aches, particularly (but not only) right hip and knee that have arthritis- worst sx ~ 36 hours post vaccination. Ongoing intermittently. Heart palpitations but unable to determine if related to vaccination. Chest pain, mid-left sternal, intermittent, ongoing. More of a muscular pain/discomfort. Note: for 1st injection had some similar "side effects" but also some that were different.
55 2021-01-16 palpitations I received the vaccine about 8:55 AM, about 9:05 AM my heart started pounding and I got dizzy for se... Read more
I received the vaccine about 8:55 AM, about 9:05 AM my heart started pounding and I got dizzy for several minutes. My lips, tongue, lower jaw and teeth started to feel tingly and strange. This started to get better in about 30 minutes but didn't completely resolve for about 3 hours.
55 2021-01-17 palpitations, chest pain 12 hours after injection: Heart racing, pounding in chest, chills, significant body aches, muscle ac... Read more
12 hours after injection: Heart racing, pounding in chest, chills, significant body aches, muscle aches, dizziness, headache, disorientation. 20 hours after injection: swelling of lips. Continued body aches, headache, 32 hours after injection: chest pain, continued body aches, headache, swelling of lips.
55 2021-01-17 chest discomfort Heart fluttering; chest pressure; This is a spontaneous report from a contactable nurse (patient). A... Read more
Heart fluttering; chest pressure; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number: EK5730; expiration date: not known), via an unspecified route of administration in the left arm at hospital on 31Dec2020 10:00 at at single dose for COVID-19 immunization. Medical history included known allergies with sulfa. The patient is not pregnant. The patient's concomitant medications were not reported. The patient previously took clarithromycin (BIAXIN), metronidazole benzoate (FLAGYL), and sulfamethoxazole, trimethoprim (BACTRIM), and all but experienced allergies (reported as "known allergies: Biaxin, Flagyl, sulfa, Bactrim"). No COVID prior to vaccination and no COVID tested post vaccination. The patient experienced heart fluttering and chest pressure on 04Jan2021. There was no treatment received for the reported events. The outcome of the events was not recovered.; Sender's Comments: A causal relationship between the reported heart fluttering and the use of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be completely excluded due to temporal relationship. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
55 2021-01-18 palpitations Anxious, tingling, heart racing, throat closing. Pt was given 25 mg IM. Pt started feeling within 15... Read more
Anxious, tingling, heart racing, throat closing. Pt was given 25 mg IM. Pt started feeling within 15 mins. PT vitals returned to normal within 10 mins. Pt discharged home with friend.
55 2021-01-18 chest discomfort General malaise and chest tightness
55 2021-01-18 chest discomfort I received the vaccine and approx 1min I developed chest pressure, head pressure, Dizzy + lightheade... Read more
I received the vaccine and approx 1min I developed chest pressure, head pressure, Dizzy + lightheaded - Had a hard time waking to gurney due to dizzy. BP +180s Back burning pain traveling mid back to lower back, joint pain, general weakness, throat scratchy, itichess on legs + Think I was monitored for 2 1/2 hrs and sent home after Benadry + Tylenol given. I have continued to have extreme fatigue. general weakness, lightheaded, dizzy and burning back pain lasted 11 days. Today is 12th day and still have lightheaded, dizzy intermittent and general weakness, fatigue, "no energy."
55 2021-01-18 palpitations Reported heart palpitations, shortness of breath and headache. Transferred to the ED. Feeling better... Read more
Reported heart palpitations, shortness of breath and headache. Transferred to the ED. Feeling better 1/19. Will follow up with PCP.
55 2021-01-18 palpitations Reported sharp pain to the left arm, heart palpitations. Symptoms resolved. Will follow up with PCP.
55 2021-01-18 fainting Syncopal episode
55 2021-01-19 blood pressure increased, palpitations Covid vaccine, felt dizzy with palpitations 5 minutes after. Elevated bp 150s systolic. No past m... Read more
Covid vaccine, felt dizzy with palpitations 5 minutes after. Elevated bp 150s systolic. No past medical history no surgical history.
55 2021-01-19 heart rate increased, palpitations, blood pressure increased Patient experienced heart palpitations, increased heart rate (100) and increased Blood pressure (210... Read more
Patient experienced heart palpitations, increased heart rate (100) and increased Blood pressure (210/120) - patient sent to ER via ambulance
55 2021-01-19 chest discomfort Per patient she began experiencing shortness of breath and tightness in her chest a few minutes aft... Read more
Per patient she began experiencing shortness of breath and tightness in her chest a few minutes after vaccine administration. Pt reports using her inhaler and nebulizer treatments with relief in symptoms. Symptoms have persisted for 24 hours.
55 2021-01-19 heart rate decreased, heart rate irregular on 1/12 started body aches and chills, took Tylenol and felt better, Wednesday felt short beat and i... Read more
on 1/12 started body aches and chills, took Tylenol and felt better, Wednesday felt short beat and irregular and heart beat not regular. checked pulse and it was irregular, that night 9-9:30 I went to ER close to house and pulse and heart rate abnormal after 2 hours went home and advised to contact cardiologist, he said to come in Thursday and the irregular beats were off and on atrial flutter, on Friday I came home and went back to hospital and got the shot cardio version or ablation to revert the rhythm and because the rhythm was back and forth I was observed until released on 1/19/21. Surgery was in 2017 and never had problems and they stated heart was compromised and maybe this is your reaction to the vaccine.
55 2021-01-20 heart rate increased After injection immediately had odd taste on my tongue. Had elevated heart rate few minutes after va... Read more
After injection immediately had odd taste on my tongue. Had elevated heart rate few minutes after vaccination and intermittently x 5 days after the vaccine. Following day had tingling to the right side of my upper lip and right side of face felt somewhat numb. Had pain to right side of face up to right ear.
55 2021-01-20 blood pressure increased Second day my arm felt really heavy 5th day I started getting anxious and my blood pressure elevated
55 2021-01-20 heart rate increased, fainting several fainting spells because of everything going on; elevated HR in the 130's; Uncontrollable chi... Read more
several fainting spells because of everything going on; elevated HR in the 130's; Uncontrollable chills; fever of 102.8; pain all over my body; intractable vomiting; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot EL0140, via an unspecified route of administration in left arm on 07Jan2021 10:45 at single dose for covid-19 immunisation. Medical history included covid-19 on an unknown date prior vaccination. There were not known allergies. Covid was not tested post vaccination. Concomitant medication included vitamin D; vitamin E. On 08Jan2021 at 02:00 the patient experienced several fainting spells because of everything going on, uncontrollable chills, fever of 102.8, pain all over the body, elevated heart rate in the 130's, and intractable vomiting. The patient was not treated for the events. The outcome of the events was resolved in Jan2021.; Sender's Comments: Based on the time association, all events are reasonably related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
55 2021-01-21 oxygen saturation decreased Aprox 8-10 hrs after vaccine chills/ rigors, extreme fatigue, body aches, abd pain at Crohns hotspot... Read more
Aprox 8-10 hrs after vaccine chills/ rigors, extreme fatigue, body aches, abd pain at Crohns hotspots: @ 12hrs temp 102.6 F: @ 15hrs Oxygen desaturation 89-90%, weakness, extreme fatigue Seen at ED aprox 6PM on 1/9/21: CBC, chem panel, CT abd, CXR Continued to have low sats and was admitted to hospital on 1/10/21 adverse reaction to vaccine, Reactive airway, asthma excerbation discharged on 1/12/21
55 2021-01-21 fast heart rate Muscle pain, tachycardia, headache, insomnia, nasal congestion
55 2021-01-21 chest discomfort SORE THROAT, CONGESTION, FUNNY FEELING IN CHEST (UNSURE HOW TO DESCRIBE), TEMP 99-100, MILD ACHINESS
55 2021-01-22 blood pressure increased I received the first dose on 1/15/2021 around 3 pm. At around 8;30 PM, I felt an extreme shot of ad... Read more
I received the first dose on 1/15/2021 around 3 pm. At around 8;30 PM, I felt an extreme shot of adrenaline starting in toe,s that then traveled to my chest. I felt this wave come over my body and I knew something was wrong. I have HIGH BP, so i know what symptoms indicate another high BP event. . I measured my BP and it rocketed to 180/150. This event lasted less than five minutes. I ingested One Clonidine tablet and my pressure decreased. Outside of that ONE incident I had very little adverse events.
55 2021-01-24 chest pain, palpitations, chest discomfort I had vaccine at 8:30 and 11 i started having palpitations and chest pressure and light headed and d... Read more
I had vaccine at 8:30 and 11 i started having palpitations and chest pressure and light headed and diaphoretic while i was at work. i continued to work and didn't go home until close to 4pm, i thought it would go away like the first time but it didn't, i went home and laid down and took a zanax and it didn't go away. the next morning i went to the ER and they put me on a telemetry monitor and i was having bigeminy and palpitations and i thought my heart was going to come out of my chest and was hurting they gave me 4mg of morphine, 2 hrs they gave me more morphine, i was nauseated they gave me Zofran then it finally subsided later but till had bigeminy and chest pressure, they admitted me and i stayed overnight. i had the PVC and bigeminy slowed down i had an echo and it was normal the potassium was low and they gave me kedar, i was still ight headed and nauseated they gave me Zofran prn it was 4-5 doses they gave me IV fluid, my fever with up to 100.4, i was not really eating that 24 hrs because i was afraid to throw up. the doctor gave me meds to take home to manage light symptoms . i went home and felt tired and had more palpitations when i move around too much and I'm still having issues today. i have not gone back to work since the vaccination and have an appointment with cardiologist 2:pm tomorrow and today I will see my PCP at 1pm. I have not recovered and still having issues and very tired.
55 2021-01-24 loss of consciousness, fainting Intense throbbing and pain at injection site, severe nausea, got up to vomit in bathroom, fainted an... Read more
Intense throbbing and pain at injection site, severe nausea, got up to vomit in bathroom, fainted and hit my head, was unconscious a couple of minutes.
55 2021-01-26 heart rate increased Soreness in neck; headache; nausea; joint ache; jaws hurting; rapid heartbeat; fatigue; This is a sp... Read more
Soreness in neck; headache; nausea; joint ache; jaws hurting; rapid heartbeat; fatigue; This is a spontaneous report from a contactable other healthcare professional (patient). A 55-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL3248), via an unspecified route of administration on 08Jan2021 14:30 (reported as 02:30 PM) at single dose on the left arm for COVID-19 immunization. Patient is not pregnant. Medical history included Attack cardia, reflux and arthritis. Concomitant medications (other medications in two weeks) included amoxicillin, verapamil, omeprazole, estradiol (ESTROGEN) and cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]). No other vaccine in four weeks. The patient previously took morphine, Remeron, azithromycin and digoxin and experienced allergies. No COVID prior vaccination. The patient experienced soreness in neck, headache, nausea, joint ache, jaws hurting, rapid heartbeat and fatigue on 09Jan2021 8:00 AM. No treatment received for the events. Outcome of the events was recovering. Patient was not tested for COVID post vaccination.
55 2021-01-28 blood pressure increased, fast heart rate Dizziness for 4 days Swollen face Increased Heart Rate and Blood Pressure
55 2021-01-28 platelet count decreased Patient received vaccine Thursday 1/21/21 and experienced headache and fatigue for two days. By Sat... Read more
Patient received vaccine Thursday 1/21/21 and experienced headache and fatigue for two days. By Saturday, her symptoms began to improve. On Monday 1/25/21, the patient developed a petechial rash around the injection site and noticed sores on her gums and the patient went to OR. Evaluation at outside ED showed a platelet count of 2,000 with a normal H/H. Patient was transferred to our hospital for increased level of care, hematology consult and platelet transfusions. Significant hematology workup with a clinical picture thought to be consistent with ITP. Patient started on dexamethasone 40mg and received IVIG x 3 doses and platelet counts have started to improve
55 2021-01-29 heart rate increased Felt flushed and tired by 8pm that night of injection,Jan 12. Woke the next morning with worst heada... Read more
Felt flushed and tired by 8pm that night of injection,Jan 12. Woke the next morning with worst headache I've ever had, in addition to horrible neck stiffness. Slept most of the day. Felt awful. 28 hours after vaccine started vomiting. Vomited for almost 24 hours. Had stomach pain the night of the 15th. Had a low grade temp the next day 16th and on the 17th my heart rate was elevated as high as the 150's. The whole time I was tired. I was Covid tested the 14th because symptoms were so severe but it was negative. I was abnormally tired but finally felt normal by January 19th.
55 2021-01-31 palpitations Severe Dizziness; nausea; body pain; It felt heavy and temporary unable to raise; Severe chills (fel... Read more
Severe Dizziness; nausea; body pain; It felt heavy and temporary unable to raise; Severe chills (felt like all my internal organs are frozen cold); heartbeat sounded strong beats (can feel the pump); Body weakness; muscle weakness; It felt heavy and temporary unable to raise; This is a spontaneous report from a contactable consumer reported for herself. This 55-year-old female patient received the 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), via an unspecified route of administration at left arm on 14Jan2021 at single dose for covid-19 immunisation. Medical history and concomitant medications were unknown. The patient experienced severe dizziness (BP normal at 120/80), nausea, body pain, while sideways lying down: unable to raise right foot or raise her foot. It felt heavy and temporary unable to raise for two days, severe chills (felt like all my internal organs are frozen cold), heartbeat sounded strong beats (can feel the pump) for at least 2 days, body weakness or muscle weakness.Start date for all events were 14Jan2021. Meclizine 25mg was received as treatment. The patient had no Covid tested post vaccination. The patient was not pregnant. The patient had no other vaccine in four weeks or other medications in two weeks. The patient had no known allergies. The patient had all normal from blood glucose of 109 and bp 120/80 on 14Jan2021, day of vaccine was a perfect day. Outcome of all events was recovering. No follow-up attempts are possible. No further information is expected.
55 2021-01-31 palpitations The patient received the vaccine at 8:30 am. Reported no issues with first vaccine. The patient rep... Read more
The patient received the vaccine at 8:30 am. Reported no issues with first vaccine. The patient reported driving and feeling lightheaded and heart started racing. The patient pulled over sat and walked around and felt better. Then got back in the car and kept driving, heart was racing again, couldn't move fingers, blood was pounding, fingers appeared white and numb. The patient called 911 and volunteer firefighter came, ambulance arrived and could move fingers again. Blood pressure was 136/104. For 10-15 minutes fingers felt numb and tingly, light headedness, and heart racing all stopped. The patient drove home and was not taken to the hospital and felt weak and shaky for about an hour.
55 2021-02-01 chest pain, heart rate increased Shaking , burning in arm, leg chest face, rapid heart rate
55 2021-02-03 palpitations About 10 minutes after I received the vaccine I felt my heart flutter. At the time I didn't think an... Read more
About 10 minutes after I received the vaccine I felt my heart flutter. At the time I didn't think anything of it but the flutter continued and felt like my heart was skipping a beat. This continued the next day (Friday) so I reached out to my doctor. She placed me on a Beta Blocker which reduced the number of palpitations. Today is 4 weeks since I had my first dose of the vaccine and I am still feeling my heart flutter.
55 2021-02-03 fainting CG received 2nd Covid Vaccine 1/11/2021; S/Sx Vertigo,,dizzy,,foggy feeling,generalized malaise on 1... Read more
CG received 2nd Covid Vaccine 1/11/2021; S/Sx Vertigo,,dizzy,,foggy feeling,generalized malaise on 1/12/21. on 1/13/21 felt near normal. Then 1/14/21 ,almost passed out on way to work,foggy feeling,vertigo,dizzy & therefore called in sick for today,1/14/21. . Vertigo, loss of balance, extreme malaise, near syncopal episodes. . I continued to have neurological symptoms both days. Vertigo, loss of balance, extreme malaise, near syncopal episodes. . 1/20: I continued to have neurological symptoms both days. Vertigo, loss of balance, extreme malaise, near syncopal episodes on 1/15.
55 2021-02-03 chest discomfort, hypertension Patient BP went very high and experienced chest tightening and shortness of breath
55 2021-02-03 pallor, hypertension, chest discomfort, chest pain Patient felt she had warmth at site of injection,89 HR 81. Patient says normal BP 120's/80's. Pati... Read more
Patient felt she had warmth at site of injection,89 HR 81. Patient says normal BP 120's/80's. Patient states she is not anxious. She then started feeling like her throat and chest were getting itchy. Continued monitoring and she felt she needed to be evaluated in ER. Taken to ER. ED notes as follows: 55 y.o. female who arrived by to the emergency department for Throat and chest discomfort associated with voice change and pruritic rash. Past medical history of food and environmental allergies, Addison's disease, thyroid disease, primary immune deficiency disorder. Half an hour ago, the patient received her first injection the Covid vaccine. Seconds later, the patient started having a pruriti rash where the site of the injection was. She then noticed her chest getting red and warm. About 15 minutes later, the patient noticed her voice becoming hoarse her and associated with throat and chest discomfort. Reports that she is unable to take a deep breath. Denies any noisy breathing, nausea, vomiting, abdominal pain, shortness of breath, difficulty swallowing, drooling. She has never been hospitalized for anaphylaxis. She denies any past medical history of asthma or COPD Vital signs demonstrate hypertension with systolic blood pressures into the 180-190s. No oropharyngeal swelling. Hoarse voice. Scleral injection present bilaterally. Chest wall nontender. Mild, blanching, erythematous, pruritic rash on anterior chest. Shallow breathing when asked to take a deep breath. Injection site covered with bandaid with no other obvious rashes or swelling patient arrived to the ED in no acute distress and in stable condition. She was complaining of throat discomfort with voice changes. She has never had an anaphylaxis reaction before. She was given benadryl, famotidine, and methylprednisolone initially for her reaction. With her hypertension and reported chest discomfort, epinephrine was not given initially.   Her symptoms mildly improved with the initial treatment.   Patient complained of chest discomfort and EKG showing T wave inverted in leads V4-5. She was given aspirin. Initial troponin negative and repeat was ordered.   After four hours of observation, the patient reports her voice change has resolved but continued to have pruritis in different, migrating areas of the body such as ears, neck, and arms.   1330: patient complaining of increasing chest and abdominal pain. Described as a cramping chest pain that radiated to her abdominal. Denies nausea, vomiting or diaphoresis. Continues to deny shortness of breath. Given morphine for her pain and aspirin for her nonspecific EKG changes.   Internal Medicine consulted for admission due to allergic reaction. Patient is agreeable to this plan. Patient was transferred under stable condition to the IM service. Initial Vital Signs [02/03/21 1159] Blood Pressure 168/101 Heart Rate 73 Respiratory Rate 15 Temp 36.8 °C (98.3 °F) Temp src Oral SpO2 96 % Following one day admission she was discharged to home with Zio patch monitoring while on new beta-blocker therapy for symptomatic PVCs with plan for PCP follow-up. Regarding adverse drug reaction, she was advised to follow-up with PCP and immunologist for further discussion on benefits:risk of subsequent vaccine in series.
55 2021-02-04 fast heart rate Headache, fatigue, muscle ache, tachycardia, sore throat (mild), severe pain at injection site lim... Read more
Headache, fatigue, muscle ache, tachycardia, sore throat (mild), severe pain at injection site limiting movement, eye pain and blurring. All began approximately 12 hours after vaccination. Did report to the ER at Summit Medical Center 2/3/2021 . Labs were drawn, ekg and cxr done. Md stated all normal. (I had pneumonia and was in a fib upon arrival to Vanderbilt Medical Center when I was admitted there with Covid in March 2020.)
55 2021-02-04 platelet count decreased petechial rash around injection site and mouth; found to have platelet count of 2,000.; patient had ... Read more
petechial rash around injection site and mouth; found to have platelet count of 2,000.; patient had ITP; extreme headaches; fatigue; This is a spontaneous report from a contactable pharmacist. A 55-year-old non-pregnant female patient of received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular on 21Jan2021 as first single dose for covid-19 immunization. Medical history included hypertension, diabetes, arthritis from unknown dates. Concomitant medication within two weeks included albuterol (salbutamol), dulaglutide (TRULICITY), escitalopram oxalate (LEXAPRO), glimepiride (MANUFACTURER UNKNOWN), hydrochlorothiazide (MANUFACTURER UNKNOWN), insulin glargine (BASAGLAR), lisinopril (MANUFACTURER UNKNOWN), lorazepam (MANUFACTURER UNKNOWN), metformin (MANUFACTURER UNKNOWN). The patient previously took ibuprofen (MOTRIN) and experienced allergies and drug intolerance. The patient experienced serious events, that involved hospitalization and were life threatening illness (immediate risk of death from the event) as follows: The patient experienced extreme headaches on 21Jan2021 with outcome of recovering; fatigue on 21Jan2021 with outcome of recovering; petechial rash around injection site and mouth on 25Jan2021 with outcome of recovering; patient had immune thrombocytopenia (ITP) on 21Jan2021 with outcome of recovering; found to have platelet count of 2,000 on 25Jan2021 with outcome of recovering. The patient was hospitalized for extreme headaches, fatigue, petechial rash around injection site and mouth, patient had ITP and found to have platelet count of 2,000 for five days. The events were also serious as they were considered life-threatening. The patient underwent lab tests and procedures which included platelet count 2,000 on 25Jan2021; platelet count 1,000 on 25Jan2021. Details were as follows: following the vaccine , which had been 21Jan2021 and had extreme headaches and fatigue for the next two days. On 25Jan2021, the patient developed petechial rash around injection site and mouth. Patient was seen at OSH emergency department and found to have platelet count of 2,000. Patient transferred to the reports facility on 25Jan2021 for hematology consult, and was found to have platelets of 1,000. Extensive hematology workup was completed and it was determined patient had ITP. Therapeutic measures were taken as a result of extreme headaches, fatigue, petechial rash around injection site and mouth (petechiae), patient had ITP and found to have platelet count of 2,000. Therapeutic measures included platelet transfusion, dexamethasone 40mg daily, 3 doses of IVIG. The patient was recovering from the events as aforementioned. The patient has not been COVID tested post vaccination. The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.; Sender's Comments: Based on the information available, a possible contributory role of the suspect products cannot be excluded for the reported event due to temporal association. However patient underlying medical conditions cannot be ruled out as contributing to the reported events
55 2021-02-04 heart rate increased racing heart rate around 48 hours after vaccine; Headache for 24 hours (mild); Intermittent shortnes... Read more
racing heart rate around 48 hours after vaccine; Headache for 24 hours (mild); Intermittent shortness of breath for 48 hours; This is a spontaneous report from a contactable consumer, the patient. This 55 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), dose 2 , single dose via an unspecified route of administration in the right arm on 19Jan2021 at 09:30 AM (at the age of 55 years-old) for COVID-19 vaccination. The patient was not pregnant. Prior to the vaccination, the patient was not diagnosed with COVID-19. Medical history included allergy to codeine. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown ), dose 1, single dose via an unspecified route of administration in the right arm on 29Dec2020 at 03:45 PM. Concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. The patient did not receive any other medication in two weeks. On 19Jan2021 at 05: 00 PM, the patient experienced mild headache for 24 hours and intermittent shortness of breath for 48 hours. On an unknown date, the patient had racing heart rate around 48 hours after vaccine. There was no treatment received for the events. The clinical outcome of events, mild headache and shortness of breath was recovered on an unknown date in Jan2021. The outcome of the event racing heart rate was recovered on an unknown date. It was also reported that since the vaccination, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
55 2021-02-05 chest pain Headache, lightheaded, dizziness, bilat foot and arm numbness, chest pain, SOB
55 2021-02-07 blood pressure increased, heart rate increased Heart rate went from normal (53-60) to 100 bpm; Felt flushing feeling; blood pressure went up to 127... Read more
Heart rate went from normal (53-60) to 100 bpm; Felt flushing feeling; blood pressure went up to 127/90 (usually 90/60); Had difficulty swallowing; Fingers started tingling; Chills (lasted 15-20 minutes); This is a spontaneous report from a contactable consumer. A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 15Jan2021 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient was not pregnant. Patient was not diagnosed with COVID-19 prior to vaccination. It was unknown if the patient has been tested for COVID-19 since the vaccination. On 15Jan2021, after 2 minutes of the vaccine, patient heart rate went from normal (53-60) to 100 bpm; the patient felt flushing feeling and blood pressure went up to 127/90 (usually 90/60); patient had difficulty swallowing and fingers started tingling, followed by chills (lasted 15-20 minutes, as reported). The patient was ok 90 minutes after the shot. No treatment given. The final outcome of all the events was recovered in Jan2021.Information on the batch/lot number has been requested.
55 2021-02-07 heart rate increased Night chills/sweating; HR of 130/HR was 120; soreness and bumps to anus; soreness and bumps to anus;... Read more
Night chills/sweating; HR of 130/HR was 120; soreness and bumps to anus; soreness and bumps to anus; Bodyaches; fever; chills/Night chills; nausea; headache/mild headache; muscle weakness; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL3249, via an unspecified route of administration in the left arm on 07Jan2021 at a SINGLE DOSE for COVID-19 immunization. Medical history included palpitations. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Patient was not pregnant at the time of vaccination. Historical vaccine included first dose of BNT162B2 on 18Dec2020 at 17:00 via intramuscular route of administration in the left arm for COVID-19 immunization. Concomitant medication included atenolol, vitamin b complex, colecalciferol (VITAMIN D), vitamins (MV), esomeprazole magnesium (NEXIUM), omeprazole (PROTON) and fish oil. The patient previously took morphine and experienced allergies. On 08Jan2021, 1 day post-vaccination after the second dose of vaccine, the patient experienced body aches, fever, chills, nausea, headache and muscle weakness. Then on 18Jan2021, she had night chills and sweating, HR (heart rate) of 130, and mild headache. She also noticed soreness and bumps to anus on 18Jan2021. On 19Jan2021, patient still had chills, HR was 120 and continue to feel muscle weakness Took 100mg atenolol to decrease HR. Usually prn 25 mg atenolol. The soreness and bump increase and was growing. Patient will consult with cardiologist regarding HR. The outcome of events body aches, fever, nausea, headache and was recovered on 13Jan2021. The outcome of event chills, muscle weakness, soreness and bumps to anus was not recovered. The outcome of the other events was unknown. Patient did not receive any treatment for the events body aches, fever, nausea, headache and muscle weakness. Whereas therapeutic measure was taken as a result of "HR of 130/HR was 120". No follow-up attempts are possible. No further information is expected. Information on the lot/batch number has been obtained.
55 2021-02-07 chest pain PATIENT ACQUIRED COVID-19 ON 12/29/2020 AND SYMPTOMS WERE EXHAUSTION, SEVERE HEADACHE, BODY ACHES, C... Read more
PATIENT ACQUIRED COVID-19 ON 12/29/2020 AND SYMPTOMS WERE EXHAUSTION, SEVERE HEADACHE, BODY ACHES, COUGH, SOB, CHILLS, SWEATS, FEVER OF 103 DEGREES, RHINORRHEA, CHEST PAIN, FATIGUE, TIREDNESS, WEAKNESS, SUDDEN LOSS OF SENSE OF TASTE,, SUDDEN LOSS OF SENSE OF SMELL.
55 2021-02-07 chest discomfort, chest pain symptoms of COVID/ believes it could be COVID; symptoms of COVID/ believes it could be COVID; terrib... Read more
symptoms of COVID/ believes it could be COVID; symptoms of COVID/ believes it could be COVID; terrible diarrhea; constant headache; Gas; Bloating; Her arm was sore for 24 hours; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number: EL8982, unknown expiration), via injection once to right arm on 14Jan2021 at a single dose as she is eligible with first tier for vaccination. Medical history and concomitant medications reported as none. The patient reported that she received the first dose of COVID vaccine on 14Jan2021 (Thursday). The next day (15Jan2021), her arm was sore for 24 hours after the shot, and she didn't have any side effects over the weekend. On 19Jan2021, Tuesday, she started having constant headache, and was experiencing problems with gas and bloating, it is very rare for her to have this issue, and it was building the last of couple days, she was uncomfortable and was taking over the counter medication for relief. She was keeping the headaches at bay with generic ibuprofen (lot: S200378, expiry: Mar2023), but if she missed a dose or is feeling better and doesn't take, it is coming back, it is consistent. Gas and bloating are primarily after eating, on Wednesday, after 24 hours it was ridiculous. She got some generic Extra Strength Gas Relief one tablet after eating (lot: 75257, expiry: Jun2022), and it was giving her some relief until early this morning. Tuesday, Wednesday, and Thursday, the gas and bloating was worse. Last night, her entire chest, she wanted to burp so bad, but couldn't because it really hurt, and it took a while for the next tablet to kick in and give relief, she was like where is this coming from, she didn't know it could build up so much. On 22Jan2021, she had a terrible diarrhea. Diarrhea was painful and intense, she took generic Pepto Bismol 1-2 tablets, and she took 4, The first time she woke up at 04:30 AM and at 7 another wave hit her, so she took another two tablets. Right now, she is feeling okay, but the gas is building up, her chest is filling, she is uncomfortable. The patient asked if these are reported side effects. She works in a dental office, and the doctor is knowledgeable and sensitive to COVID, and even though those symptoms are not listed as side effects on the information sheet, the doctor said they are symptoms of COVID, and even though those symptoms are not listed as side effects on the information sheet, the doctor said they are symptoms of COVID, are these side effects or may she have COVID, though she doesn't know who she could have gotten COVID from. Out of protection for patients at dental clinic, the HCP at clinic wants her to get the COVID test as he believes it could be COVID and not side effect of the vaccine. She doesn't want to quarantine for nothing if it is just side effects of the vaccine. She will be getting rapid diagnostic for COVID and not the antibody test. She thinks she should get tested, but there is no testing appointment available until tomorrow, and she does not want to self-quarantine needlessly, she will live through it, she is happy to get the test, but she doesn't want to lose 2 weeks of pay if others are reporting the same side effects. She was happy to get the vaccine. The patient recovered from the event arm sore on 16Jan2021; not yet recovered from events constant headache, gas, and bloating; while unknown outcome for the remaining events.
55 2021-02-09 heart rate increased Lot of tightness under my breast; Heart rate is elevated; Felt I wanted to vomit and then I vomited;... Read more
Lot of tightness under my breast; Heart rate is elevated; Felt I wanted to vomit and then I vomited; Felt I wanted to vomit and then I vomited; Chills; Had a bowel movement, it felt soft; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date: not reported), via an unspecified route of administration on 22Jan2021 at single dose for COVID-19 immunisation. Medical history included hypertension, type 2 diabetes, and acid reflux from an unknown date. Concomitant medication included hydrochlorothiazide, olmesartan medoxomil (OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE) for hypertension, labetalol for hypertension, metformin for type 2 diabetes, and pantoprazole for acid reflux. It was reported that the patient took the shot on Friday, 22Jan2021 and everything was fine, felt fine. Today, 24Jan2021 the patient was requested to call because on Saturday, 23Jan2021, the patient woke up, and got herself something to eat. The patient took her medication as normal and may be about, after she ate a meal, took the medicine (unspecified medication), the patient felt she wanted to vomit and then she vomited, she felt chills. She immediately had a bowel movement, it was like soft. She just wanted to just lay down and she went on and she just went to work because she was thinking it is just a shot and it will subside but she did want to get to work and felt she cannot do it. She came home and this morning (24Jan2021) and just felt a lot of tightness under her breast. She did not know if it had anything to do with it? Her heart rate is elevated a little it is like 104 because she is hypertensive. The patient reported that she did not have treatment and was going to go and get an X-ray as to why she is feeling this tightness under her breast. The patient underwent lab tests and procedures which included heart rate: 104 (elevated) on 24Jan2021. The outcome of the events was unknown. Information on Lot/batch number has been requested.
55 2021-02-17 chest discomfort anaphylactic reaction; Chest tightness; This is a spontaneous report from a contactable consumer. A ... Read more
anaphylactic reaction; Chest tightness; This is a spontaneous report from a contactable consumer. A 55-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL9261), via an unspecified route of administration on 30Jan2021 09:30 at single dose for covid-19 immunisation. Medical history included severe peanut allergy. Concomitant medication included diphenhydramine hydrochloride (BENADRYL), methylprednisolone sodium succinate (SOLU-MEDROL), both for severe peanut allergy. She went to the Emergency Room after having an anaphylactic reaction on 31Jan2021. She was in the emergency room for four hours. She has taken Solu-Medrol and Benadryl. She has a severe peanut allergy that she had this medication for it. The anaphylactic reaction last for 24 hours. She also experienced chest tightness on 31Jan2021 that continued. She was given Epinephrine, Solu-Medrol and Benadryl in the ambulance. Therapeutic measures were taken as a result of anaphylactic reaction and chest tightness. The outcome of anaphylactic reaction was recovered on 31Jan2021, for chest tightness was not recovered. No follow-up attempts are possible. No further information is expected.
55 2021-02-23 chest discomfort, pallor, lightheadedness Near syncopal episode Diaphoretic, lightheaded, pale, nausea, abdominal pain Onset approx 09:45 am ,... Read more
Near syncopal episode Diaphoretic, lightheaded, pale, nausea, abdominal pain Onset approx 09:45 am , IV fluids administered, IV Ephedrine administered, EKG, telemetry monitor Taken to ER ,
55 2021-02-24 pallor COVID-19 Vaccine Pt received her 1st dose of Covid-19 vaccination in her left deltiod at 1340. 12 m... Read more
COVID-19 Vaccine Pt received her 1st dose of Covid-19 vaccination in her left deltiod at 1340. 12 min later, pt stuck her head out of the doorway of her room to notify LPN that she was feeling lightheaded. LPN went to pt's room to assess. Patient laid back in exam chair. Patient mask removed. Color palor. Skin clammy, Vitals obtained, patient reports tingling in arms, legs, and feet. Patient vitals 96/67. Provider at door for eval and advised EMS notification. Patient vitals monitored. 20G IV placed at 1358 left forearm by RN x1 NSL. Color begins to return. Patient tilted back up in chair, vitals obtained and WNL. At 1423 patient stood up with stand by assistance, placed mask on herself and reports does not feel can stand at this time. Patient A&O x4. Reports lightheadedness and dizziness. Patient asks what she is to do about her second vaccine and was advised that she needs to consult with her PCP. Pt states will take Benadryl. Pt again advised to check with her PCP before having second dose or taking Benadryl with second dose. Patient advised per EMS to bring second person with for transport if cleared to receive second dose. At 1428 reports no lightheadedness or dizziness with standing. At 1429 patient ate three PB crackers with water. At 1432 patient ambulatory in halls with Medic staff by side. At 1434 back to room, reports 95% better with head, tinglining in feet and hands 90% improvement. At 1445 vitals WNL patient A&O x4. At 1449 IV pulled by RN. At 1452 patient discharged to home per self.
55 2021-02-24 atrial fibrillation Cardiac dysrhythmia. Paxoxsymal A-fib, atrial tachycardia.
55 2021-02-24 chest pain Large area of swelling around injection site about the size of a softball measuring 14 cm in diamete... Read more
Large area of swelling around injection site about the size of a softball measuring 14 cm in diameter. Treatment- anti-inflammatories- ibuprofen. It has now been 1 week and is down to 4 cm. Also, on 2/23 had a flair-up of the post CoVid syndrome and ended up in the ER with chest pain and severe shortness of breath. All cardiac tests came back within normal limits. Chest X-ray just showed atelectasis in bases remaining from bilat CoVid pneumonia 3 months ago. Diagnosis was post CoVid syndrome. Treatment - nebulizer and anti-inflammatories - more ibuprofen. Returned to baseline shortness of breath that has existed since having CoVid in November in about 8 hours. I'm not sure if this was a reaction to the vaccine, but thought I would include it.
55 2021-02-24 palpitations Patient complained of "Hot everywhere, chest and heart racing" Denies SOB Bp 139/78, hr 64, oxygen ... Read more
Patient complained of "Hot everywhere, chest and heart racing" Denies SOB Bp 139/78, hr 64, oxygen level 99% on room air. EMS at patient's side at clinic, evaluated and discussed symptoms with patient. No interventions needed at this time and patient monitored for an additional 15 mins. VS remain stable and at 1045a, BP was 142/76, oxygen level 100%, HR 58 with patient states feeling better and feels she can drive home. EMS released patient.
55 2021-02-25 hypertension Broke out in hives on my back and blood pressure was very high
55 2021-02-25 palpitations Patient at 15 minutes post vaccination stated her heart was racing and had trouble swallowing. Patie... Read more
Patient at 15 minutes post vaccination stated her heart was racing and had trouble swallowing. Patient given Epinephrine 0.3 IM, Benadryl 50 MG IM, and Solumedrol 62.5 mg IM and then sent to ER.
55 2021-02-25 palpitations Patient reported feeling cold in the chest, and palpitations. Has history of anxiety. After observat... Read more
Patient reported feeling cold in the chest, and palpitations. Has history of anxiety. After observation, reported feeling better.
55 2021-02-28 palpitations Immediately after vaccination (10min) patient developed heart palpations that are still ongoing (6 w... Read more
Immediately after vaccination (10min) patient developed heart palpations that are still ongoing (6 weeks later). It was worst the first 2 days. Doctor put patient on a beta blocker which helped some.
55 2021-02-28 deep vein blood clot severe pain and swelling in left lower leg. Diagnosed with 2 DVTs 3 days later in emergency room.
55 2021-03-03 chest discomfort chest tightness. some wheezing.
55 2021-03-04 chest pain dizziness and chest pain. Evaluated by EMS-Cleared
55 2021-03-10 heart attack extreme weakness; joint pain in neck; mouth pain; severe heart attack; 10 hrs after shot severe chil... Read more
extreme weakness; joint pain in neck; mouth pain; severe heart attack; 10 hrs after shot severe chills; 1 hr later explosive diarrhea; vomiting; severe joint pain in ankles, knees, hips, elbows; severe headache; This is a spontaneous report from a contactable nurse report for self. A 55-year-old female (not pregnant) patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200), intramuscular in left arm on 21Feb2021 10:45 AM at single dose for covid-19 immunisation. The patient's medical history was not reported. No COVID prior vaccination. Concomitant medications in two weeks included atorvastatin, aspirin [acetylsalicylic acid], ergocalciferol (VIT D), cetirizine hydrochloride (ZYRTEC). No other vaccine in four weeks. Patient was allergy to morphine. Patient received first dose of bnt162b2 (lot number=EL9263) intramuscular in left arm on 30Jan2021 09:30 AM. On 21Feb2021, 1 hr later patient experienced explosive diarrhea and vomiting 1 time, severe joint pain in ankles, knees, hips, elbows, severe headache. 10 hrs after shot patient had severe chills. Next day joint pain in neck and mouth pain along with severe heart attack. On 23Feb2021 had extreme weakness. No treatment received. Patient was recovered from the events. Nasal Swab Covid test post vaccination on 22Feb2021 was Negative.; Sender's Comments: Based on the limited information provided it is unlikely that heart attack was related to suspect product in this patient on atorvastatin and aspirin. Case will be reassessed when additional information is received. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
55 2021-03-16 low blood oxigenation 4 days psot vaccine patient developed eye angioedema and hives resulting in ED visit. 6 days post v... Read more
4 days psot vaccine patient developed eye angioedema and hives resulting in ED visit. 6 days post vaccine she devleoped flu like sxs with positive covid 19 test results on day 8 post vaccine as per pateint. 10 days post vaccine patient with dyspnea and hypoxemia-admitted to hospital.
55 2021-03-17 loss of consciousness pass out; 11 hours post injection developed severe lumber pain that radiated to front; the pain inte... Read more
pass out; 11 hours post injection developed severe lumber pain that radiated to front; the pain internally radiated up toward stomach so severe/lower lumbar pain; dull headaches; Some night sweats; This is a spontaneous report from a contactable nurse (patient). A 55-year-old non-pregnant female patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9265) on left arm intramuscularly from 28Jan2021 15:00 (03:00 PM) at single dose for covid-19 immunisation. Medical history included gastrooesophageal reflux disease (GERD), allergies to trees, pollen, grasses and latex. Concomitant medication included omeprazole (PRILOSEC), sucralfate (CARAFATE), sertraline hydrochloride (ZOLOFT), montelukast sodium (SINGULAIR), levocetirizine dihydrochloride (XYZAL) , minerals nos/ vitamins nos (OPTISOURCE CHEWABLE VITAMIN & MINERAL SUPPLEMENT). There was no other vaccine in four weeks. The patient historical vaccine included bnt162b2 (lot number: EL1284) for first dose on 04Jan2021, 03:00 PM, Intramuscularly, left arm, for covid-19 immunisation. The patient previously took metoclopramide (REGLAN), pethidine hydrochloride (DEMEROL) and hydrochlorothiazide (HCTZ) and all had allergies. On 29Jan2021, 02:00 AM, 11 hours post injection developed severe lumber pain that radiated to front; the pain internally radiated up toward stomach so severe it caused me to pass out. In Jan 2021, 20 hours to 48 hours post injection continued to have dull headaches and lower lumbar pain achy at this point. Some night sweats. The vaccination facility type is hospital. There was no covid prior vaccination and covid tested post vaccination. There was no treatment for the events. The events were not result in emergency room visit or physician office visit. The outcome the events recovered in Jan2021.; Sender's Comments: Based on the compatible time association, the event back pain and loss of consciousness are possibly related to suspect vaccine BNT162B2 administration.The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
55 2021-03-22 chest discomfort - Pt has history of anaphylaxis to flu shots, even requiring intubation at one point - Pt?s doctors ... Read more
- Pt has history of anaphylaxis to flu shots, even requiring intubation at one point - Pt?s doctors and ID team discussed risks of COVID vaccine and determined low risk due to no similar components between flu vaccine and COVID vaccine - Pt received first dose of COVID vaccine today (3/22/21) around 1230 - Within 10 minutes of injection, pt felt nauseous and was flush. She was given a drink and snack, monitored for 30 minutes, and felt better ? went back to work upstairs - 4 hours post injection (~1630) pt came to ED - itchy throat, hoarseness, urge to clear her throat, chest heaviness - In ED, pt has received methylprednisolone 125 mg, famotidine 20 mg, diphenhydramine 25 mg, duonebs, epinephrine 0.3 mg IM, and fluids with improvement. - Pt is being admitted for further monitoring
55 2021-03-23 deep vein blood clot, chest discomfort, chest pain, fibrin d dimer increased, pulmonary embolism Day of shot developed pain in entire right side(chest area), also acid reflux and nausea. That went ... Read more
Day of shot developed pain in entire right side(chest area), also acid reflux and nausea. That went away about 12 hours after the vaccine. Ten days after I developed a slight pain in right lateral side that progresses to constant pain in 2 places on right side including under right clavicle. I had pain upon taking in a deep breath. Saw MD after 4 days of these SXS. Performed labs, Chest x-ray and EKG. All were essentially normal except elevated WBC count. Have 2 COVID test which were both normal. Md said possibly some sort of inflammation and suggested taking anti-inflammatories which did not help much at all with SXS. After a few more days the SXS changed to constant chest pain(pressure), SOB upon exertion and pain behind knee. F/U with MD again and it was decided to wait a few more days. Upon suggestion from friend asked MD to perform D-Dimer lab test. The result was 4,400. My normal value should have been 550. Sent to ER. CT of chest, EKG and more labs performed. CT revealed large bilateral pulmonary embolisms in pulmonary arteries. Started on blood thinners. Ultrasound of left leg revealed large DVT. Sent home after 2 days on blood thinners. SXS stopped after a few days.
55 2021-03-23 heart rate increased, fast heart rate Vaccine had triggered my heart arrhythmia; My heart rate start to race; Tachycardia; This is a spont... Read more
Vaccine had triggered my heart arrhythmia; My heart rate start to race; Tachycardia; This is a spontaneous report from a contactable consumer. A 55-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL 9261), via an unspecified route of administration, administered in the left arm on 19Jan2021 16:15 as a single dose for covid-19 immunisation. The patient's medical history included supraventricular tachycardia (SVT), atrial fibrillation (Afib), atrial flutter, colon cancer, endometrial cancer, Lynch Syndrome, asthma, osteoarthritis, lung nodules being watched, kidney cysts, obesity and enlarged liver all from unknown date. Concomitant medications included metoprolol tartrate; alprazolam; acetylsalicylic acid (ASPIRIN LOW); ascorbic acid (VIT C); and colecalciferol (VIT D3). The patient previously took epinephrine and experienced sensitivity (reported as (sensitive to epinephrine due to heart arrytmia). The patient received the first dose of bnt162b2 (lot:ELI284) on 29Dec2020 in the left arm for covid-19 immunization. On 19Jan2010 at 16:15, the patient experienced within the first minute or two, she felt her heart rate start to race. She used Kardia device to check it and she was in Tachycardia at 16:15. The patient mentioned that she carry device with her since she have a history of SVT, Atrial Flutter, and AFib, with prior ablations. Patient was pretty familiar with what Tachycardia feels like so she was pretty sure she was not having an allergic reaction to the vaccine, but rather the vaccine had triggered her heart arrhythmia. After continuing to monitor her HR, for approx. 20 minutes, and it continued to stay at 135 -145, the doctor who had administered the vaccine took her to the local hospital to have her evaluated. The patient received this vaccine at the facility where she was employed. The outcome of the events was recovered on an unspecified date in 2021.
55 2021-03-25 heart attack STEMI, ventricular fibrillation decreased ejection fraction to 30%
55 2021-03-30 heart attack Patient received first dose of Pfizer COVID-19 vaccine on 3/22/21, the next day the patient reported... Read more
Patient received first dose of Pfizer COVID-19 vaccine on 3/22/21, the next day the patient reported feeling myalgia, diarrhea, and body aches and chills. The patient presented to the ED and was admitted with myocarditis and NSTEMI. Left heart cath did not show evidence of epicardial coronary artery disease. The patient was discharged from the hospital after receiving fluid resuscitation and supportive care. The patient returned to the ED with worsening myocarditis and was found to be in cardiogenic shock requiring vasopressor support. The patient developed VT storm and was intubated and sedated. The patient is currently in the ICU and remains intubated and sedated
55 2021-03-31 chest pain I am not sure if this is from the vaccine or not, but ever since I received the second dose of the v... Read more
I am not sure if this is from the vaccine or not, but ever since I received the second dose of the vaccine I have had alot of GI issues. Chest pain, belching, inflammation in throat, headaches, body aches, weight loss, fatigue.
55 2021-04-01 cerebrovascular accident, blood pressure increased her stomach was bothering her; her daughter told her the right side of her tongue looked swollen; al... Read more
her stomach was bothering her; her daughter told her the right side of her tongue looked swollen; allergic reaction to the COVID-19 Vaccine; heaviness with her headache; stroke; Facial droop; Numbness / left half of her face was numb /numbness in her left hand/numbness and tingling all over her body; Tingling; Tiredness; Pain; Headache; This is a spontaneous report received from a contactable consumer, the patient. A 55-year-old adult female received the first dose of BNT162b2 (solution for injection; Lot EN6202 and expiry information not provided) via unspecified route in the left arm on 03Mar2021 between 17:10 and 17:30 (at 55-years-old) for COVID-19 immunisation. Relevant medical history included Frozen shoulder (2020-2020), and severe migraines (especially in the past ten years). The patient further stated that she has always had migraines. She said sometimes when her migraines escalate, her blood pressure goes up, and her left side tingles. She said several times in the past, she thought her migraine symptoms may have been a stroke. She said she her doctor is checking her for any kind of things like rheumatoid arthritis, mast cells, constant (chronic) fatigue, and fibromyalgia. She said right before the COVID-19 Virus pandemic she had passed out unexpectedly. She said she doesn't know what caused her to pass out. She said she needs another neurological test done. She said she had a neurological test that maybe showed that veins were dying in her brain, but she wasn't sure. She said her doctor had been doing heart tests too, but because of the pandemic, it was taking longer to have the tests done. The patient also mentioned that her last blood work was probably in/around Nov2020. There were no concomitant medications or past drug history reported. The patient denied receiving any other vaccination within the four weeks prior to the vaccination. The patient also denied receiving any other vaccination on the same date as the vaccination. The patient reported that on 04Mar2021, approximately seventeen hours after she received the COVID-19 vaccine, she had what she thought was a kind of severe reaction. She said she had an inside numbness and tingling all over her body. She said the left side of her body, especially, had a very strong numbness and tingling, like a stroke. She said the numbness was in her left hand, and outside left shoulder. She said the left half of her face was numb. She said at the time she felt weird. She said she was speaking to her friend on a video call and did not want her friend to think she was a cry baby. She said then her friend told her there was something happening with her face. She said the right side of her face had dropped. She said her right eye and the right side of her mouth were drooping. She said she told her friend she thought she had an allergic reaction to the COVID-19 Vaccine. She said it took about three hours for her symptoms to pass. She said afterward she was so tired, had pain, and a headache. She said it was strange for her to have a headache because she was used to migraines. She said she still had a headache today (08Mar2021). She said she had a heaviness with her headache. She said if she had a migraine, she would not be able to do anything, but with the headache she had, she was able to go about her everyday things. She said her stomach was bothering her too, but she was not worried about how her stomach felt. The events did not require any visits to a physician's office nor the emergency room. Treatment for the events included drinking a lot of water and moving around. The outcome of the events, inside numbness and tingling all over her body, very strong numbness and tingling, like a stroke¸ numbness was in her left hand, and outside left shoulder, half of her face was numb, right side of her face had dropped, and tongue looked swollen, and allergic reaction to the COVID-19 Vaccine was recovered on 04Mar2021 after about three hours duration. The outcome of the events so tired, and pain was recovered on an unspecified date in Mar2021. The outcome of the events, headache, and heaviness with her headache was not recovered.
55 2021-04-06 deep vein blood clot I began developing pain in my left leg Friday, March 19th - two days after receiving my second injec... Read more
I began developing pain in my left leg Friday, March 19th - two days after receiving my second injection. My early Monday morning I was in so much pain that I went to the ER. I was diagnosed with acute DVT in my entire left leg from the Iliac vein in my abdomen down to the ankle. The entire leg was occluded.
55 2021-04-06 chest discomfort felt like there was a lot of pressure on her chest/heaviness in chest; congestion; Lip swelling; Ups... Read more
felt like there was a lot of pressure on her chest/heaviness in chest; congestion; Lip swelling; Upset stomach; shortness of breath; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 22Mar2021 13:00 (Lot Number: ER2613) as SINGLE DOSE for COVID-19 immunisation. Medical history included thyroid from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine sodium (TIROSINT) taken for thyroid, start and stop date were not reported. The patient previously took thiomersal and experienced allergy to thiomersal. On 22Mar2021, the patient had some reactions to BNT162B2, the patient was curious if she should take the second one, knowing how the patient's body. The patient waited for 30 minutes after the vaccine to make sure something didn't happen. The patient started to have lip swelling so she went back into the facility and waited a little longer, the swelling subsided on their own but then she started having shortness of breath through the evening, but not to the point to go to the emergency room. The patient felt like there was a lot of pressure on her chest, congestion and upset stomach. The main symptom was the heaviness in the chest. The outcome of congestion, lip swelling and upset stomach was recovering and the outcome of the rest of the events was unknown.
55 2021-04-09 chest discomfort in respiratory distress; Mild lightheaded; itchy; rash; severe headache; tightening in chest/tightne... Read more
in respiratory distress; Mild lightheaded; itchy; rash; severe headache; tightening in chest/tightness chest; voice increasing hoarse/decreased voice volume and able to say 2 words max; coughing; shortness of breath; very effortful to talk; Eyes droopy; tingling jaw, neck; stressful; Unable to do anything seconda; This is a spontaneous report received from a contactable consumer (patient). A 55-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EP7534), via an unspecified route of administration at Arm Left on 24Mar2021 08:30 (at age of 55 years old) at single dose for COVID-19 immunization. Medical history included Type1 diabetes, allergies, Shellfish allergy. Concomitant medication included insulin lispro (HUMALOG); pravastatin sodium (PRAVASTATIN +PHARMA); cetirizine hydrochloride (ZYRTEC ALLERGY). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 24Mar2021 09:30 AM, the patient experienced mild lightheaded first 1/2, by 90mins post skin itchy with rash just under skin, severe headache, tightening in chest, voice increasing hoarse, coughing, shortness of breath, decreased voice volume and able to say 2 words max, no observed swelling but in respiratory distress. Went to AMC Umergent care, epipen + benedryl +steroids administered, transferred to AMC hospital via ambulance. Monitored, IV fluids+ Pepcid, stabilized d/c home on 50mg prednisone + Pepcid. Symptoms (milder)reoccur in Wednesday pm, Thursday AM, Thursday PM following Pepcid. Friday Mild coughing during the day, but overall good energy, activity level, almost back to normal. 1/2 hour prior to prednisone 4:30 pm starting experiencing respiratory symptoms again. Vitals all stable, but very effortful to talk, exhale (coughing). Eyes droopy, tingling jaw, neck, tightness chest. Overall took 1.5 hours post prednisone for symptoms to improve and voice to return to almost normal. Very stressful. Unable to do anything seconda. AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Treatment (EPINEPHRINE, BENEDRYL, PEPCID, PREDNISONE) received for AE. The outcome of the events was unknown. Information on the lot/batch number has been provided. Other information has been requested.
55 2021-04-09 fainting must have fainted; severe nausea; This is a spontaneous report from a contactable consumer. A 55-ye... Read more
must have fainted; severe nausea; This is a spontaneous report from a contactable consumer. A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered on right arm on 25Mar2021 14:00 (Batch/Lot Number: EW6204) at single dose (at the age of 55 years old) for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications included estradiol, progesterone, esomeprazole sodium (NEXIUM [ESOMEPRAZOLE SODIUM]) and spironolactone, all taken for an unspecified indication, start and stop date were not reported. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1, on 04Mar2021 (Lot number: EN6198), 02:00 PM on the right arm. The patient stated on 26Mar2021, "woke up with severe nausea, went to restroom, must have fainted, because I came to with my face on the register vent". The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
55 2021-04-13 cerebrovascular accident That evening after getting 2nd shot I was rushed to ER because I has slurred speech- I went to ER an... Read more
That evening after getting 2nd shot I was rushed to ER because I has slurred speech- I went to ER and they initially thought I had bells palsy, but after a CT to confirm they found a brain bleed and I was rushed to hospital and put in the ICU and after two MRI's they also found a stroke - I had several tests and stayed in ICU for 5 days they could never determine the cause of the brain bleed or stroke - all tests were negative for autoimmune diseases.
55 2021-04-14 chest discomfort 55 YEAR OLD FEMALE REPORTED TIGHTNESS IN CHEST AND HEADACHE ABOUT 30 MINUTES AFTER VACCINATION. ON ... Read more
55 YEAR OLD FEMALE REPORTED TIGHTNESS IN CHEST AND HEADACHE ABOUT 30 MINUTES AFTER VACCINATION. ON SITE EMS RESPONDED, VITALS BELOW. SHE WAS MONITORED AND RELEASED TO HOME.
55 2021-04-14 blood pressure decreased Client reports swelling in both hands after receiving the vaccine Fire Rescue evaluated patient. Pa... Read more
Client reports swelling in both hands after receiving the vaccine Fire Rescue evaluated patient. Patient had her own Benadryl and self administered 25 mg. orally. Swelling began to decrease and BP lowered as well. No presence of hives or SOB. Per Fire Rescue no further evaluation needed. Client released at 12:00pm.
55 2021-04-14 chest pain Metallic taste in mouth, chest pains
55 2021-04-18 fainting I then felt very fatigued & came down with w/a fever that night.; the headache was improved; I felt ... Read more
I then felt very fatigued & came down with w/a fever that night.; the headache was improved; I felt a lot of fatigue; a lot of arm pain; I felt some mild dizziness later in the day; irritable bowels throughout the day as well as a loss of appetite./My appetite is very much diminished; irritable bowels throughout the day as well as a loss of appetite.; I also started experiencing an odd ribcage/breast pain on the side of the injection (left side).; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient (Patient was not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot Number: EW0150), via an unspecified route of administration in the left arm on 02Apr2021 (age at time of vaccination: 55-years-old) at a single dose for COVID-19 immunization. Medical history included asthma, allergies to medications, food, or other products as Tree Nuts and NSAIDS. Concomitant medication patient received within 2 weeks of vaccination included zyrtec, vitamins C, Vitamin D, Vitamin E, Probiotic and Tylenol. The patient previously took first dose of BNT162B2 for COVID-19 immunization. The patient experienced about 90 mins after 1 vaccine dose on 02Apr2021 at 04:00 PM, she developed a strong headache. The patient then felt very fatigued and came down with fever that night. The next day (yesterday), the headache was improved still present but she felt a lot of fatigue and a lot of arm pain. She felt some mild dizziness later in the day and irritable bowels throughout the day as well as a loss of appetite. On 02Apr2021, a day after 2 vaccine dose, she again felt fatigued with mild headache. her appetite was very much diminished with still irritable bowels. She also started experiencing an odd ribcage or breast pain on the side of the injection, it was felt like deep shooting pains. There was no pain or redness or swelling. she not breast issues to date (last mammography was clear-Fall 2018). Facility where the most recent COVID-19 vaccine was administered was Clinic. The event was considered as non-serious. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. No treatment was received for the events. The patient underwent lab tests and procedures which included Nasal swab was unknown on 02Apr2021. The outcome of the events was not recovered. Information on Lot/Batch number was available. Additional information has been requested.
55 2021-04-23 heart rate increased fever at 102.6; Heart Rate 103; muscle/big joint pain; muscle/big joint pain; This is a spontaneous ... Read more
fever at 102.6; Heart Rate 103; muscle/big joint pain; muscle/big joint pain; This is a spontaneous report from a contactable consumer (patient). A 55-years-old non pregnant female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 09Feb2021 09:30 (Batch/Lot Number: EL9265) as SINGLE DOSE (30mcg/0.3 mL) for covid-19 immunisation. Medical history included Type 2 Diabetes. Concomitant medication(s) included metformin (METFORMIN) taken for an unspecified indication, start and stop date were not reported. The patient previously received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 19Jan2021, 11:00 AM (Batch/Lot Number: EL3249) as SINGLE DOSE (30mcg/0.3 mL) for covid-19 immunisation. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. Known allergies was None. It was reported that the patient had fever at 102.6 Heart Rate 103, muscle/big joint pain 12th hr after 2nd dose on 09Feb2021 10:00 PM (22.00). fever reduced to 99.9F heart Rate 72 by 36th hr after vacinned, no muscle/joint pain temperature 98.6, heart rate 62 by 48 hr after. temperature 97.9 heart rate 66 by 72 hr after. No treatment received for AE. Outcome of the events was resolved in Feb2021.
55 2021-04-24 heart rate increased felt like precursor to an anaphylactic response; Rapid heart rate; metallic taste; throat pressure; ... Read more
felt like precursor to an anaphylactic response; Rapid heart rate; metallic taste; throat pressure; dry mouth; This is a spontaneous report from a contactable consumer (Patient herself). A 56-Year-old female (non-pregnant) patient received BNT162B2 (BNT162B2, Formulation: solution for injection, Batch/Lot was not reported) via unspecified route of administration and administered in left arm on 07Apr2021 14:00 as single dose for COVID-19 immunization. The patient no medical history and known allergies includes shellfish allergy and penicillin allergy, Levaquin, doxycycline were reported. The patient concomitant medications within two weeks included as Linzess, Prilosec, miralax, vitamin D were reported. Patient was not on other vaccines within four weeks. Patient had no Covid prior to vaccination and not tested for covid post vaccination. On 07Apr202 14:00 PM, the patient experienced rapid heart rate and metallic taste and dry mouth and throat pressure- felt like precursor to an anaphylactic response. Symptom onset was immediate and was decreased in 8 hours but still present 24 hours later. No therapeutic measures were taken. The outcome of the events was recovering.
55 2021-04-26 chest pain this feels like an auto immune thyroid attack; headache/pain in back of head; serious pain heat burn... Read more
this feels like an auto immune thyroid attack; headache/pain in back of head; serious pain heat burning and redness in front of neck and sides of neck thyroid and chest area; serious pain heat burning and redness in front of neck and sides of neck thyroid and chest area; serious pain heat burning and redness in front of neck and sides of neck thyroid and chest area; serious pain heat burning and redness in front of neck and sides of neck thyroid and chest area; serious pain heat burning and redness in front of neck and sides of neck thyroid and chest area/ The area is also really red and warm to the touch; frontal neck muscles are contracting under chin and on the sides; throat is burning; The area is also really red and warm to the touch; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 55-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in right arm on 03Apr2021 at 14:15 (02:15 PM) (at the age of 55 years old) (Batch/Lot number was not reported) as a single dose for COVID-19 immunization; and thyroid (ARMOUR THYROID) via unspecified route of administration on unspecified date at 15mg for unspecified indication. Medical history included hypothyroidism and known allergies to sulfa drugs. The patient previously took quinolines and experienced allergies. On 04Apr2021 at 10:00 AM, the patient experienced headache/pain in back of head, but also serious pain heat burning and redness in front of neck and sides of neck thyroid and chest area. This began on day 2 and increased days 3,4,5,6, it became very pronounced after taking Armor Thyroid 15mg medication. It also feels like her frontal neck muscles are contracting under chin and on the sides and throat is burning. The patient called her doctor but no return call yet. She had normal labs several weeks ago for thyroid. She went today again as this feels like an auto immune thyroid attack. The area is also really red and warm to the touch. The patient did not receive other vaccine in four weeks. The patient has no COVID prior to vaccination and was not tested for COVID post vaccination. The patient did not received treatment for the events. The events resulted in doctor or other healthcare professional office/clinic visit. The action taken in response to the events for ARMOUR THYROID was unknown. The patient had not yet recovered from the events. Information on the lot/batch number has been requested.
56 2020-12-31 palpitations Heart racing few mins after shot lasted 10 mins then nausea, dizziness continues for 45 mins. Then m... Read more
Heart racing few mins after shot lasted 10 mins then nausea, dizziness continues for 45 mins. Then mild headache for 24 hrs. No symptoms after 24 hrs except sore arm for 2 days.
56 2021-01-01 hypertension, chest discomfort headache, muscle pain, mostly in left calf area started few days after, hypertension (new onset), ch... Read more
headache, muscle pain, mostly in left calf area started few days after, hypertension (new onset), chest tightness
56 2021-01-03 heart rate increased They have my injection listed as Moderna which is a mistake. The Manufacturer is Pfizer. On the 23rd... Read more
They have my injection listed as Moderna which is a mistake. The Manufacturer is Pfizer. On the 23rd. I went into anaphalactic shock admitted to the ER, given an epinephrine drip, I was given iv bolises, chest xray, vitals were taken and blood was drawn. ABGs and chest xray and lactic acid tests were administered. I have to carry a epi pen and need to see a pulmonologist, I have triggers now where I need an emergency inhalor and was put on a course of steroids and my heartbeat is 20 beats higher than usual. I was really tired and having abdominal pain .
56 2021-01-05 fast heart rate Headache, Myalgia, Tachycardia, Significant chills also reported. Required employee to be away from ... Read more
Headache, Myalgia, Tachycardia, Significant chills also reported. Required employee to be away from work, reported greater than 16 hours of sleep second to the overwhelming fatigue
56 2021-01-06 chest pain C/O left arm pain radiating down arm and up neck; pointed to mid-sternal area and reported "chest tw... Read more
C/O left arm pain radiating down arm and up neck; pointed to mid-sternal area and reported "chest twinge". Radial pulse measured 88- pulse felt weak. Brought over to EMS for evaluation, monitor shows HR 87, BP 185/98 (160/88 manual), O2 99% on RA. HR came down to 79, BP 142/80. Around 0910 c/o nausea and dizziness. 0915 called daughter to drive her home, refused to transfer with EMT to hospital.
56 2021-01-06 loss of consciousness Patient was feeling nauseous after the vaccination. Went and ate lunch. When she came back from lunc... Read more
Patient was feeling nauseous after the vaccination. Went and ate lunch. When she came back from lunch, she passed out and a code blue was called. She never lost a pulse, but when in the ER she could not speak. She responded to commands without speaking. About 30 minutes later, she finally spoke.
56 2021-01-06 fast heart rate, chest discomfort Pt. states that she received vaccine and ten minutes after vaccination she started coughing, having ... Read more
Pt. states that she received vaccine and ten minutes after vaccination she started coughing, having tachycardia hr in the 110s, fullness feeling to head, chest irritation. Went to ER, discharged same day. On drive home she started having bilateral lower extremity weakness and felt super sleepy. 01/01/21 symptoms resolved. 01/02/21 woke up with chills at 2am, went back to sleep, woke back up at 5 am same day and symptoms resolved. 01/03/21-mild headache-took Tylenol sinus-headache resolved. Pt. states that she has felt fine ever since.
56 2021-01-06 fainting SkinRash, CoughWheeze & Syncope
56 2021-01-07 chest discomfort 35 minutes After vaccination.... complaints of chest tightness, "funny" tongue
56 2021-01-07 heart rate increased, chest discomfort 48 hours after the vaccine , I awoke from a sleep with chills; Approximately 5-10 minutes after rece... Read more
48 hours after the vaccine , I awoke from a sleep with chills; Approximately 5-10 minutes after receiving the pfizer covid-19 vaccine . My heart rate became elevated 110-120 , my chest was irritated, my head felt full and a started to cough.; Approximately 5-10 minutes after receiving the pfizer covid-19 vaccine . My heart rate became elevated 110-120 , my chest was irritated, my head felt full and a started to cough.; Approximately 5-10 minutes after receiving the pfizer covid-19 vaccine . My heart rate became elevated 110-120 , my chest was irritated, my head felt full and a started to cough.; Approximately 5-10 minutes after receiving the pfizer covid-19 vaccine . My heart rate became elevated 110-120 , my chest was irritated, my head felt full and a started to cough.; I still felt a little weak in my legs; This is a spontaneous report from a contactable nurses. A 56-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 vaccine; lot EK9231, expiration date unspecified), via an unspecified route of administration on 31Dec2020 at 13:00 at single dose at right arm for COVID-19 immunization. Medical history included hypertension, cholesterol (abnormal) and hypothyroid which were well managed. The patient was not pregnant at the time of vaccination and had no allergies to medications, food or other products. Concomitant medications were not reported. On 31Dec2020 at 13:30, approximately 5-10 minutes after receiving the Pfizer covid-19 vaccine, patient's heart rate became elevated at 110-120, chest was irritated, head felt full and started to cough. Patient was taken to the emergency room (ER) and was placed on a monitor/EKG was obtained. Patient was released to home that same day, however she still felt a little weak in her legs. It was reported that 48 hours after the vaccine, the patient awoke from a sleep with chills, all her vitals were within normal limits, but the dry cough had returned. The patient was treated with fluids, vitals, EKG closely monitored and rapid cov (as reported). The events resulted to a doctor or healthcare professional office/ clinic visit. The patient was vaccinated at the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and there were other medications the patient received within 2 weeks of vaccination. The patient underwent lab tests and procedures which included a nasal swab was negative on 31Dec2020. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. Outcome of events was unknown.
56 2021-01-07 palpitations Came to ER on 12/20/20 with chills, heart palpitations, body aches and increased SOB. Had ST elevat... Read more
Came to ER on 12/20/20 with chills, heart palpitations, body aches and increased SOB. Had ST elevation on EKG in ER, taken to Cath Lab- no intervention done. D/C home 12/22/20. Previous Hx of COVID per patient
56 2021-01-07 chest pain HEAD ACHE, MUSCULAR ACHES, FEVER, CHEST PAIN AND IRREGULAR HEART RATE, EDEMA, ITCH, ERYTHEMA, ENLARG... Read more
HEAD ACHE, MUSCULAR ACHES, FEVER, CHEST PAIN AND IRREGULAR HEART RATE, EDEMA, ITCH, ERYTHEMA, ENLARGEMENT OF LYMPH NODE
56 2021-01-07 palpitations Patient C/O palpations, hot, dizzy, slightly nauseated. No SOB Patient observed x 40 minutes B/... Read more
Patient C/O palpations, hot, dizzy, slightly nauseated. No SOB Patient observed x 40 minutes B/P 126/86 HR 76 Sat 96% Patient did elect to call her husband to pick her up
56 2021-01-07 oxygen saturation decreased Patient received first dose of Pfizer COVID-19 vaccine on December 26. On the next day, December 27... Read more
Patient received first dose of Pfizer COVID-19 vaccine on December 26. On the next day, December 27, patient started having pressure in her head and sinuses, weakness. Then she developed nonproductive cough and progressive shortness of breath. She was seen at urgent care and tested positive for COVID-19 on December 29. She had low oxygen saturation on home oximeter and severe shortness of breath. Patient's husband is also ill with COVID-19 at home. Patient was sent to the ED and admitted to the hospital.
56 2021-01-07 blood pressure increased, heart rate increased Patient reported feeling shaky and presented with increased HR and BP five minutes after injection. ... Read more
Patient reported feeling shaky and presented with increased HR and BP five minutes after injection. O2 100% RA. Patient provided with snacks and water. Status monitored during observation of 30 mins. All symptoms resolved at discharge from vaccine clinic.
56 2021-01-07 hypotension Sxs started 3-5 minutes post vax. Dizziness, hypotension, throat fullness, CODE called, given IM Epi... Read more
Sxs started 3-5 minutes post vax. Dizziness, hypotension, throat fullness, CODE called, given IM Epi at vax site. Taken to ED from vax site. Started on epi drip. Admitted to SHC.
56 2021-01-07 hypertension The next say I exp headache I was warranted cause on of my coworkers tested positive Covid. I went t... Read more
The next say I exp headache I was warranted cause on of my coworkers tested positive Covid. I went to ER high BP and got tested for Covid results negative. On that Saturday my BP was still high and left calf pain. Since I'm usually hypotensive I monitored my BP however it has continued to elevate.
56 2021-01-08 chest pain Had COVID vaccine and was being monitored. at 11:25a she developed dizziness, nausea, chest pain, l... Read more
Had COVID vaccine and was being monitored. at 11:25a she developed dizziness, nausea, chest pain, left arm weakness/numbness, skin itching. BP checked and was 190/110, then 180/110. Hx HTN and BP meds taken today. Hx of allergies -- took loratadine and hydroxyzine this AM. Due to the dizziness and skin itching, feeling unwell/woozy with history of anaphylaxis, given epipen and called 911. EMS arrived and taken to ER.
56 2021-01-08 palpitations Metallic taste, palpitations, nausea, dizziness, flush Subsided after 30 min headache 4 hours later ... Read more
Metallic taste, palpitations, nausea, dizziness, flush Subsided after 30 min headache 4 hours later Tylenol taken Next day painful injection site, body aches chills fatigue Tylenol Advil taken with some relief
56 2021-01-09 palpitations 1st vaccine: Approximately 24 hours after vaccine, I developed chills with fever of 100.2, fatigue, ... Read more
1st vaccine: Approximately 24 hours after vaccine, I developed chills with fever of 100.2, fatigue, total body/muscle/joint aches, migraine headache, nausea, heart palpitations, as well as very sore, swollen arm. Had to spend the day in bed. Most symptoms relieved by the next 24 hours except arm pain and fatigue. 2nd vaccine: Similar, but worse symptoms developed approximately 12 hours after vaccine. All of the aforementioned symptoms, but fever of 101.4 and arm wasn't quite as sore. As above, had to spend a day in bed.
56 2021-01-10 palpitations Severe headache, Fever 100.9F, Dizzy, Nausea, Heart Palpitations, Head congestion, severe fatigue. A... Read more
Severe headache, Fever 100.9F, Dizzy, Nausea, Heart Palpitations, Head congestion, severe fatigue. All lasting approximately 12 hours.
56 2021-01-10 heart rate increased feeling flushed elevated HR dizzy nausea evaluated by EMS, VSS and wnl except HR 100 bpm lungs cta ... Read more
feeling flushed elevated HR dizzy nausea evaluated by EMS, VSS and wnl except HR 100 bpm lungs cta at 5:36 patient reported to be feeling better - drank water - declined transport to ER - felt able/safe to drive home
56 2021-01-11 blood pressure increased I got extremely hot with sweating, I got a massive headache that started at the base of my neck tha... Read more
I got extremely hot with sweating, I got a massive headache that started at the base of my neck that effected my vision. I was dizzy, BP was high over 140, temperature increased. I had some tingling in my upper extremeties. I had really bad GI pains, I had itching and a light rash. I had to go to the ED where I received a cocktail.
56 2021-01-11 chest pain Initially what seemed like a muscle spasm involving entire left arm/neck/chest. Followed by tirednes... Read more
Initially what seemed like a muscle spasm involving entire left arm/neck/chest. Followed by tiredness. Approximately 2.5hrs later developed generalized muscle aches, tired, chills. Next morning muscle aches were less, new headache and dizziness. took Tylenol which helped, about 5 hrs later symptoms worsened, improved with sleep and Tylenol. Awoke this morning with some chest pain similar to initial response, some headache and dizziness, improved with Tylenol, now returning (noon). occasionally feels like I need to take a deep breath. I believe its mostly muscular pain gets a little worse with deep breathing. Sent home from work day of vaccine, worked partial days next 2 days
56 2021-01-11 heart rate increased chills, elevated heart rate, headache, Sore Arm
56 2021-01-12 hypotension 1/11/21 woke up feeling tired, muscle aches, took migraine medicine, and ibuprofen. Back pain towar... Read more
1/11/21 woke up feeling tired, muscle aches, took migraine medicine, and ibuprofen. Back pain toward the kidney, stomach area. Felt like she would pass out. Dizzy, nausea. Seeing a patient she had to leave the room and go sit on the floor. Blood pressure was very low, couldn't stand up. Painful to have clothes touching the skin all over. Felt like she need more air, panting. Didn't sleep 8-10 hours. Started with sever H/A and muscle pain. Sensitive to light and sound. Fatigue. Out of work 1/12-1/13. Skin sensitivity is gone. Talk big dose of ibuprofen. Still fatigue. H/A is better.
56 2021-01-12 chest discomfort Had a sore arm about 6 hours after. Four days after vaccine - 4:30 am woke up with severe nasal drai... Read more
Had a sore arm about 6 hours after. Four days after vaccine - 4:30 am woke up with severe nasal drainage and pressure. Headache. Very congested. Medicated with Mucinex and Advil Sinus. A couple days later went to my chest. Got medical care from Telemed visit - Z-Pac - took for five days - 250 mg and a liquid decongestant: Guaifenesin - 100 mg/5 mm once every six hours for 10 days as needed. I took it for six or 7 days. Resolved.
56 2021-01-13 heart rate increased, palpitations Chest palpitations and fast heart rate (99); rested and symptoms decreased
56 2021-01-13 blood pressure increased Had flushing and warm BP elevated to 158/98 pulse 68 for 30 min and resolved on own
56 2021-01-13 heart rate increased, blood pressure increased PATIENT HAS SWOLLEN, RED FACE, HEADACHE, INCREASE BLOOD PRESSURE, INCREASE HEART RATE, TROUBLE BREAT... Read more
PATIENT HAS SWOLLEN, RED FACE, HEADACHE, INCREASE BLOOD PRESSURE, INCREASE HEART RATE, TROUBLE BREATHING AFTER 2 HOURS OF ADMINISTRATION OF VACCINE. PATIENT WENT TO THE ER AND GOT EPIPEN AND ORAL BENADRYL AND ORAL ATIVAN. PATIENT IS RECOVERING NOW.
56 2021-01-13 palpitations The patient received the vaccine at 11:36am. One to two minutes after injection, she began feeling ... Read more
The patient received the vaccine at 11:36am. One to two minutes after injection, she began feeling like her heart was racing and short of breath. She was diaphoretic, had a notable tremor and reported anxiety as well. Patient was transported to the Emergency Department where the patient was monitored. Ultimately, patient felt better, with a normal EKG. Patients states this reaction felt similar to anxiety attacks she has had in the past. ED Physician felt this was likely an anxiety attack. Patient remained stable throughout ED course and was discharged from the ED in stable condition.
56 2021-01-13 palpitations Vaccine administered at 10:41. Monitored in vaccine clinic before returning to work area in PACU. ... Read more
Vaccine administered at 10:41. Monitored in vaccine clinic before returning to work area in PACU. Upon return to PACU at 10:57, felt foggy and didn't feel right. Employee sat down. Left upper lip started to tingle, patient experienced palpitations and difficulty breathing, requiring surgical mask to be removed. Code EMA (code for non-patient called). Employee taken to emergency department for evaluation.
56 2021-01-14 low platelet count, platelet count decreased mild rhabdomyolysis presentation and lymphopenia and thrombocytopenia
56 2021-01-16 loss of consciousness I got the vaccine at 5:45 Friday night was having symptoms of arm pain headache dizziness lighthead... Read more
I got the vaccine at 5:45 Friday night was having symptoms of arm pain headache dizziness lightheadedness and nausea upon awakening Saturday morning. Saturday night was having increased nausea and lightheadedness. Got up to use the bathroom at 1 AM Sunday morning was very dizzy and nauseous and passed out on my hallway floor. I woke choking on vomit, crawled to the bathroom, continued to vomit. Sustained bruised lump to forehead, bruised nose, split lips. Went back to bed. Later Sunday felt better.
56 2021-01-17 loss of consciousness, lightheadedness Pt. C/o dizzyness and weakness about 5-10 minutes after receiving her vaccine while seated in the ob... Read more
Pt. C/o dizzyness and weakness about 5-10 minutes after receiving her vaccine while seated in the observation area. Her husband and I walked her over to the cot and medical treatment area. Her pulse felt thready and weak while walking and her gait was unsteady. As soon as she sat, then lay on the cot she lost consciousness and did not respond to verbal or noxious stimuli over the next few minutes. I gave her one dose of an epi-pen into her left mid outer thigh but she still did not regain consciousness so we called a "Rapid Response code" for transport to the E.R. for further treatment and stabilization.
56 2021-01-18 blood pressure increased, fast heart rate 1st vaccine: spontaneous tachycardia (HR 110 initially) and elevated BP (160/100) at 10 minutes ma... Read more
1st vaccine: spontaneous tachycardia (HR 110 initially) and elevated BP (160/100) at 10 minutes mark which subsequently resolved spontaneously at 30 mins (closely monitored by MD, NP) 2nd vaccine: spontaneous tachycardia, and elevated BP (160/100) at 10 minutes mark (monitored by MD and NP), normalized after 1 hour of observation. On 1/8/2020 I developed severe fatigue, fever, numbness on lower lip, bitter taste in my mouth, fever, chills, headache until Sunday 1/10/2021. Went to work on 1/11/2021 with worsening symptoms. Ended up in ER on 1/12/2021 due to weakness, high BP, numbness on lower lip, difficulty focusing. BP is normalizing as of 1/19/2021 but still have weakness, equilibrium is off and difficulty in focusing
56 2021-01-18 fainting Headache, upper back and neck pain, chills, nauseated, dizzy. Patient woke up this morning to use th... Read more
Headache, upper back and neck pain, chills, nauseated, dizzy. Patient woke up this morning to use the bathroom and had a syncopal episode with no known injury.
56 2021-01-18 chest pain sore arm chest pains began on friday December 25th
56 2021-01-19 hypotension Patient reports experiencing hypotension with blood pressure of 55/39. The onset was 12 hours after ... Read more
Patient reports experiencing hypotension with blood pressure of 55/39. The onset was 12 hours after receiving the booster. Patient reports the symptoms lasted 12 hours.
56 2021-01-19 hypotension Patient reports experiencing hypotension, with blood pressure to 55/39. The onset was 12 hours after... Read more
Patient reports experiencing hypotension, with blood pressure to 55/39. The onset was 12 hours after receiving the booster dose with the symptom lasting 12 hours.
56 2021-01-19 chest pain Patient reports that she got her second COVID-19 vaccine dose today at 1100 hours. She states that s... Read more
Patient reports that she got her second COVID-19 vaccine dose today at 1100 hours. She states that she woke up from a nap around 1500 hours with constant, midsternal chest pain. Chest pain is non-exertional, non-pleuritic, and non-radiating. She states chest pain is exacerbated by certain movements. Patient endorses lightheadedness.
56 2021-01-19 fast heart rate, chest pain Tachycardia, light-headed, chest pain, left arm numbness occurring within 10 minutes of vaccination.... Read more
Tachycardia, light-headed, chest pain, left arm numbness occurring within 10 minutes of vaccination. Patient said she felt like she couldn't breathe. Taken to ED for further evaluation.
56 2021-01-19 chest pain acute stabbing pain in left arm, moved to left chest area and left side - intermittent stabs for 5-7... Read more
acute stabbing pain in left arm, moved to left chest area and left side - intermittent stabs for 5-7 minutes then stopped - 30 minutes after injection given blurry vision - 30 minutes after injection given mild shaking - following morning lasting for about 2 hours extreme fatigue - lasting for 48 hours - Sunday evening through Tuesday evening
56 2021-01-19 blood pressure increased, chest discomfort at 1:36pm client started c/o heaviness in chest, denies SOB.Client had taken Benadryl 50mg po and 2 ... Read more
at 1:36pm client started c/o heaviness in chest, denies SOB.Client had taken Benadryl 50mg po and 2 Zyrtec at 12:30pm to offset a reaction. Bp was elevated. Taken to triage area. no medications given. 2:35 pm client reports improvement is chest heaviness. Her husband was with her to drive her home.
56 2021-01-20 heart rate increased, atrial fibrillation On the evening that the recipient received the vaccine, heart rate increased for two hours, at one p... Read more
On the evening that the recipient received the vaccine, heart rate increased for two hours, at one point climbing to 140 beats per minute. Her Apple Watch detected atrial fibrillation. The atrial fibrillation resolved after two hours.
56 2021-01-20 fainting Site: Redness at Injection Site-Mild, Systemic: Generalized Body Aches -Mild, Systemic: Fainting-Mil... Read more
Site: Redness at Injection Site-Mild, Systemic: Generalized Body Aches -Mild, Systemic: Fainting-Mild, Systemic: Patient felt faint then had an overall body flushing sensation, quickly went away shortly after vaccination-Mild
56 2021-01-20 palpitations chills, sore arm, heart racing loss of appetite
56 2021-01-21 atrial fibrillation, palpitations I developed a sudden onset of heart palpitations and went to the ER to find I was in Atrial Fib with... Read more
I developed a sudden onset of heart palpitations and went to the ER to find I was in Atrial Fib with RVR. Heart rate 166 upon arrival to the ED.
56 2021-01-22 heart rate increased, blood pressure increased At the clinic today had who suffered an adverse reaction. When she came in for the vaccine she was e... Read more
At the clinic today had who suffered an adverse reaction. When she came in for the vaccine she was extremely nervous due to a hatred for needles. She got the vaccine and within 5 minutes she turned red and her blood pressure sky rocketed to 203/104. She had no difficulty breathing, no rash, just flushed skin and high blood pressure. Her pulse was also elevated to 103. Due to, the ambulance was called. She expressed her wish to not go to the hospital multiple times due to being afraid of missing work and hating the hospitals. By the time the ambulance came her blood pressure was 203/104 with a pulse of 104. Her pulse ox remained at 98 on room air. From the minute she felt ill to the minute they left made sure she was breathing ok and showed no signs of anaphylactic shock. She had a history of panic attacks and GERD, with no blood pressure problems. She did also report an allergy to latex and penicillin prior to the vaccination. All products again were double checked to show her they were latex free. Patients blood pressure decreased at the hospital and was discharged with directions to follow up with her primary. They stated they aren't sure why her blood pressure increased so high.
56 2021-01-22 palpitations Heart palpitations dizziness /or lightheadedness Assisted to reclining chair vitals done and norma... Read more
Heart palpitations dizziness /or lightheadedness Assisted to reclining chair vitals done and normal. Rested about 20 more minutes and fine.
56 2021-01-23 palpitations Heart racing from 9 AM all day, ranging from 110 to 148. My normal is 65 at rest.
56 2021-01-23 palpitations fell down on Thursday and got vaccine on Friday, Had swelling and resolved now with purple area larg... Read more
fell down on Thursday and got vaccine on Friday, Had swelling and resolved now with purple area large where swelling was and migrating to feet and experiencing dizziness, heart is racing; gasping for air over phone but able to speak a complete sentences
56 2021-01-24 fainting 2 hrs after vaccine began to feel chills, did not have good appetite and didn't eat lunch. Started f... Read more
2 hrs after vaccine began to feel chills, did not have good appetite and didn't eat lunch. Started feeling lightheaded 3 hrs post vaccine. Able to stay at work until 4pm, went home, felt lightheaded, ate a meal and felt somewhat better. Got up around 9:30pm, was on feet for a couple of minutes, went to kitchen and reached for a plate on top of the refrigerator. Had presyncopal aura, then fainted. Apparently fell on buttocks, which are sore. No other symptoms. Constitutional symptoms have resolved. Evaluated in ED today.
56 2021-01-24 chest pain Patient informed medic while sitting in the observation area that she was experiencing chest pain, d... Read more
Patient informed medic while sitting in the observation area that she was experiencing chest pain, difficulty breathing and throat tightness. Patient was taken to medic area vs=179/89, pulse 121, o@ sat 99%
56 2021-01-24 palpitations, fast heart rate Tachycardia pulse 130's, palpation, lymph node swelling, brain fog ( difficulties concentration)
56 2021-01-25 chest discomfort The first covid vaccination I had symptoms of being flush and a heaviness in my chest. This lasted ... Read more
The first covid vaccination I had symptoms of being flush and a heaviness in my chest. This lasted 4 3-4 days. I did seek medical attention at the emergency room day 3 and was hospitalized 1 day. I was found to have unexplained and unregulated hypoglycemia. The second shot I had body aches, headache, fever. I was able to manage my symptoms with Tylenol and Advil.
56 2021-01-25 blood pressure increased Within two hours of the second dose, I experienced a severe headache. It has been two weeks since ... Read more
Within two hours of the second dose, I experienced a severe headache. It has been two weeks since the injection and I still have a severe headache. Blood pressure has also been elevated resulting in physician prescribing blood pressure medication.
56 2021-01-25 chest discomfort little nauseous, queasy; low grade temperature; chills and shakes; scratchy throat; decreased sense ... Read more
little nauseous, queasy; low grade temperature; chills and shakes; scratchy throat; decreased sense of smell; decreased sense of taste; everything she eat or drinks has a metallic taste to it; muscle stiffness; Fatigue; arm soreness/right arm was still tender to touch/The first shot hurt way more and hurt all over the whole arm, it was throbbing; sinus pressure and congestion; sinus pressure and congestion; felt really lightheaded; low grade headache; chest feeling tight/chest tightness; she is not feeling good; wheeze; cough; This is a spontaneous report from a contactable nurse (patient). A 56-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular (IM) in right deltoid on 07Jan2021 15:30 at second single dose for preventative. The patient medical history was not reported. There were no concomitant medications. The patient previously took H1N1 flut shot in 2015 or 2016 for immunisation and experienced muscle stiffness and fatigue, first dose bnt162b2, via IM in left deltoid for preventative on 18Dec2020 at 18:00 and patient was tender in her left arm, the first shot hurt way more and hurt all over the whole arm, it was throbbing. No additional vaccines administered on same date of the pfizer suspect. No prior other vaccinations administered within 4 weeks. The patient took the second dose of the Pfizer Covid vaccine on Thursday 07Jan2021 at 15:30. She called employee health and was advised to call Pfizer to report side effects since she is not feeling good. She had never had the covid diagnosis. On Friday (08Jan2021) she worked all day and felt arm soreness and sinus congestion but nothing out of the ordinary. The patient reported her right arm was still tender to touch, if she rotated her arm she can feel that she had the shot and she was still tender in her left arm from the first shot. The first shot hurt way more and hurt all over the whole arm, it was throbbing. On 08Jan2021 evening she felt really lightheaded, she thought maybe it was her sinuses since it is dry due to winter. She felt like a truck hit her. She had a low grade headache. On 09Jan2021, she felt a little nauseous, queasy, no vomiting. On Saturday (09Jan2021) she had a low grade temp of 100.3 degrees F. She had the chills and shakes on Saturday and most of yesterday. She got up today (reported on 12Jan2020) at 5:30 am, she checked her temperature and it was 97.2 after the shower, an hour later it was 98 degrees F. She felt like she had to keep clearing her throat, her chest felt a bit tight which started Friday evening, the chest tightness was not terrible but it was there. She was not wheezing but when she took a deep breath she felt a little like a wheeze and she had to cough, she had a scratchy throat on 09Jan2020. She stayed home from work yesterday. The patient did not feel lightheaded today, felt it yesterday and did not notice it at all this morning, reported it has resolved. The sinus pressure and congestion started Friday night, she felt stuffy. She had a decreased sense of smell and taste on 09Jan2021. Unless something is right in front of her, she could not smell anything. She felt quite nauseous this morning but at the moment her nausea is under control. She had a decreased sense of taste, everything she ate or drunk had a metallic taste to it, on 09Jan2021. She felt that all the side effects mentioned were related to getting the vaccine. On 08Jan2021, she also experienced muscle stiffness and fatigue which had improved after a hot shower, that helped. She felt like she had a bad flu shot. The only time she ever felt similar to this was when she received the H1N1 flut shot in 2015 or 2016. She did not have lot number, NDC, or expiration date to provide. Treatment included: took Tylenol on Saturday. The events did not require a visit to emergency room and physician office (she is trying to get an appointment to see the doctor). Outcome of the event lightheaded was recovered on 12Jan2021, of events low grade headache, chest tightness, scratchy throat, sinus pressure and congestion, decreased sense of smell, decreased sense of taste, everything she eat or drinks has a metallic taste to it, arm soreness was not recovered, of events chills and shakes, muscle stiffness, fatigue was recovering, of other events was unknown. Information about Lot/Batch has been requested.
56 2021-01-25 palpitations s/p 1st dose vaccine c/o feeling flushed with palpitations and dizziness
56 2021-01-26 blood pressure increased Elevated blood pressure, rectal bleeding,and dizzy. Last for about 48 hours
56 2021-01-26 chest pain Headache with the first COVID-19 Vaccine; A little bit of chest pain; Heart Troubles; This is a spon... Read more
Headache with the first COVID-19 Vaccine; A little bit of chest pain; Heart Troubles; This is a spontaneous report from a contactable consumer. This 56-year-old female consumer reported that she the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685) at single dose for vaccination on 22Dec2020. Relevant medical history included Rheumatoid, Asthma, Artery disease, Gastroparesis. Relevant concomitant drugs were unknown. The patient had a headache with the first COVID-19 Vaccine and a little bit of chest pain. Stated she has heart troubles. Outcome of events was unknown.
56 2021-01-26 heart rate increased c/o rapid pulse, observed, symptoms improved
56 2021-01-27 fast heart rate, chest discomfort 15 minutes after vaccine given, complaints of chest pressure/tightness, tachycardia -pulse=120, c/o ... Read more
15 minutes after vaccine given, complaints of chest pressure/tightness, tachycardia -pulse=120, c/o forehead pressure. Team called, sent to ED
56 2021-01-27 palpitations metal taste, flushing, palpitations, dizziness, nausea, headache 9pm arm sorness, severe aches, chil... Read more
metal taste, flushing, palpitations, dizziness, nausea, headache 9pm arm sorness, severe aches, chills weakness, fatigue the next day aches, weakness and fatigue headache continued for 5 days fatigue and headache continues daily
56 2021-01-28 palpitations, blood pressure increased close to passing out; felt "heat waves" throughout my body; tingling; palpitations; My BP was taken ... Read more
close to passing out; felt "heat waves" throughout my body; tingling; palpitations; My BP was taken and it was 166/86 (my normal BP is usually 100/60).; This is a spontaneous report from a contactable Physician (the patient). A 56-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm, second dose, on 15Jan2021 14:30 at SINGLE DOSE for covid-19 immunisation. Medical history included hypothyroidism and gastrooesophageal reflux disease, both from an unknown date and unknown if ongoing. Concomitant medication included levothyroxine sodium (SYNTHROID), esomeprazole magnesium (NEXIUM), estradiol, norethisterone acetate (AMABELZ), estradiol, levonorgestrel (CLIMARA PRO). Patient previously received the first dose of BNT162B2 in left arm, on 24Dec2020 08:15 AM. No other vaccine in four weeks. Vaccination Facility type: Hospital. No COVID prior vaccination. COVID was not tested post vaccination. No Known allergies. On 15Jan2021 about 5 minutes after the vaccination the patient experienced close to passing out, felt "heat waves" throughout my body, tingling, palpitations, blood pressure (BP) was taken and it was 166/86 (her normal BP is usually 100/60). No treatment was given. The symptoms slowly resolved over the next 45 minutes, with BP returning back to normal. Information on Lot/Batch has been requested.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for reported "close to passing out". The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
56 2021-01-30 chest pain Uncontrollable shivering for 3 hours, headache, numbness and tingling in hands and feet, swelling an... Read more
Uncontrollable shivering for 3 hours, headache, numbness and tingling in hands and feet, swelling and redness at injection site, swollen armpit, chest pain, extreme tiredness and slept for 22 hours, weakness.
56 2021-01-31 blood pressure increased, fast heart rate, chest pain Generalized weakness; Numbness in lower lip; Prolonged malaise; Headaches; Poor equilibrium; Chest p... Read more
Generalized weakness; Numbness in lower lip; Prolonged malaise; Headaches; Poor equilibrium; Chest pain; Persistent increase in blood pressure; Intermittent tachycardia; This is a spontaneous report from a contactable nurse. This nurse reported for herself that the 56-year-old female patient who received econd dose of bnt162b2 (BNT162B2, COVID 19 Pfizer) via Intramuscular on 07Jan2021 04:00 PM on Left Arm at a single dose for covid-19 immunization. She is not pregnant. Medical history included Known allergies: Taxotere and Breast cancer. Concomitant medications included Tamoxifen. The patient previously took first dose of bnt162b2 at a single dose for covid-19 immunization. Facility type vaccine was Hospital. No other vaccine in four weeks. The patient experienced Generalized weakness Numbness in lower lip Prolonged malaise Headaches Poor equilibrium Chest pain Persistent increase in blood pressure Intermittent tachycardia from 08Jan2021 3:00 PM. AE resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The outcome of the event was unknown. No treatment received. No COVID prior vaccination. COVID tested post vaccination included Covid test post vaccination: Nasal Swab, PCR panel on 12Jan2021 with covid test result: Negative. Information Requested on Lot/ batch number.
56 2021-01-31 blood pressure increased Right after she received her dose, she just had a sore arm. 13 hours after vaccination, patient had ... Read more
Right after she received her dose, she just had a sore arm. 13 hours after vaccination, patient had a dry cough that woke her up from sleep. She then started to get a headache and took ibuprofen. She spike a temp of 99-102 degrees Fahrenheit. Blood pressure elevated to 165/100. One hour later it was 155/101. Normal baseline is 110-130/55. No visual changes occurred. After 8 hours, the blood pressure normalized. By 01/02/21, all symptoms had dissipated. I referred her to see her cardiologist for approval before second dose.
56 2021-02-01 hypertension, fast heart rate Facial flushing/sporadic facial flushing; HTN; Tachycardia 90-120 x 30 hrs; Headache; Body aches; Pa... Read more
Facial flushing/sporadic facial flushing; HTN; Tachycardia 90-120 x 30 hrs; Headache; Body aches; Painful urination; Bilateral eye pain; Chills/sporadic chills; This is a spontaneous report from a contactable nurse (patient). A 56-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EL3246, via Intramuscular on left arm on 12Jan2021 12:00pm as SINGLE DOSE for COVID-19 immunisation. Medical history included asthma, hypothyroidism, supraventricular tachycardia, Sulfa allergy, dust allergy, Maple trees and Pine Trees allergies, gastrooesophageal reflux disease. Concomitant medication included sertraline, metoprolol, estradiol, levothyroxine, pantoprazole, fexofenadine hydrochloride (ALLEGRA), fluticasone propionate (FLONASE), paracetamol (TYLENOL), and ibuprofen (ADVIL). The patient previously took Augmentin and experienced drug hypersensitivity. Historical vaccine includes first dose of BNT162B2, lot number: EH9899, on22Dec2020 08:15 AM, via intramuscular on Left arm. On 13Jan2021, the patient experienced facial flushing, HTN, Tachycardia 90-120 for 30hrs, headache, Body aches, painful urination, bilateral eye pain, chills. Then, another 48 hours of sporadic facial flushing and sporadic chills. The patient underwent COVID-19 testing via Nasal Swab post vaccination on 16Jan2021 with negative. The outcome of the events sporadic facial flushing and sporadic chills was recovered on 16Jan2021; while the rest of the events were recovered on 14Jan2021. The patient is not pregnant at the time of vaccination. No treatment was given for the events.
56 2021-02-01 heart rate irregular extreme itching and 11/2 inches big redspot on arm. The itching is so severe and cannot relieved by ... Read more
extreme itching and 11/2 inches big redspot on arm. The itching is so severe and cannot relieved by over counter hrdrocortisone, it make me feel my heart starting beat irregularly
56 2021-02-02 hypotension, fainting syncopal event; unable to move; increased respiratory rate; severe pain radiating from neck througho... Read more
syncopal event; unable to move; increased respiratory rate; severe pain radiating from neck throughout body; unable to turn head; generalized weakness; hypotension; shortness of breath; unable to speak; chills; diaphoresis; severe pain radiating from neck throughout body; This is a spontaneous report from a contactable nurse (patient). A 56-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL1283), via an unspecified route of administration on 18Jan2021 10:45 at single dose for COVID-19 immunization. Medical history included known allergies: Sulfa, shellfish. Concomitant medication included celecoxib (CELEXA), levocetirizine dihydrochloride (XYZAL), acetaminophen, ibuprofen, naproxen sodium. There were no other vaccines received in four weeks. The patient did not have Covid tested post vaccination. Upon awakening early morning after injection on 19Jan2021 04:00, the patient had severe pain radiating from neck throughout body, unable to turn head, generalized weakness, syncopal event, hypotension, increased respiratory rate, shortness of breath, unable to speak, unable to move, chills, diaphoresis, emergent to emergency department, received Intravenous NS bolus as treatment. Electrocardiogram (EKG), BMP, complete blood count (CBC), labs were Within Normal Limit on 19Jan2021, discharged home, slept all day. Feeling much better second day after injection. The reported events resulted in Emergency room/department or urgent care. Therapeutic measures were taken as a result of unable to move, syncopal event, increased respiratory rate, severe pain radiating from neck throughout body, unable to turn head, generalized weakness, hypotension, shortness of breath, unable to speak, chills, diaphoresis. The outcome of the events was recovered in Jan2021.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
56 2021-02-03 cerebrovascular accident, excessive bleeding 56 year old female presents with complaint of tingling and numbness that she noticed to her lower le... Read more
56 year old female presents with complaint of tingling and numbness that she noticed to her lower left jaw. It occurred yesterday around 3 PM after she received her Covid vaccination. She states that then started to move up to her left cheek but has now gone back down just to the lower left jaw. It is in a specific region of that area. She states also that she is having a fever today and generalized body aches that are moderate in nature. She also notes some urinary frequency without dysuria or hematuria. Patient took Tylenol this morning around 6 AM. She initially tried to swallow the pill and felt like she was going to choke on it and spit the pill up. She then sat down for a few minutes and was then able to take the pill. She denies any actual stridor or wheezing. No focal weakness or numbness of one arm or leg. No change in speech. Differential diagnoses include but are not limited to: CVA, TIA, anxiety reaction, paresthesia, metabolic process, bleed, vaccine reaction. 56-year-old female with paresthesia to the left chin. Otherwise normal neurologic examination. The TPA window given symptoms started yesterday. I will get a head CT but I do not feel the patient needs an MRI. Given the fact the patient does have autoimmune disorder, blood cultures and lactic acid obtained. I suspect that her fever is in response to her Covid vaccine yesterday. Covid test negative. Urinalysis no evidence of UTI. Chest x-ray is clear. Head CT negative. On reevaluation after Motrin patient feels much improved. At this time I think she is stable for discharge to home. I do not think this is Bell's I am finding no facial weakness on my examination. Follow-up and return precautions discussed patient understood
56 2021-02-03 palpitations Heart palpitations/racing heart. Dr. Appointment scheduled.
56 2021-02-03 heart rate increased Heart rate at 210 for approx. 10-15 mins. I was driving when event occurred and I had to pull over ... Read more
Heart rate at 210 for approx. 10-15 mins. I was driving when event occurred and I had to pull over and wait until heart rate came down. I have Exercise induced but never had a SVT event without exercise like this.
56 2021-02-04 chest pain chest soreness/pain; pain with breathing/hurt to breathe; severe fatigue; soreness at injection site... Read more
chest soreness/pain; pain with breathing/hurt to breathe; severe fatigue; soreness at injection site; This is a spontaneous report from a contactable other healthcare professional (hcp), reporting for herself. A 56-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE;lot ELO142) , on 18Jan2021 at 09:00 intramuscular in Right arm at single dose for COVID-19 immunization.Medical history included allergy to Shellfish. Patient was not pregnant. Concomitant medication included ibuprofen (ADVIL) prophylactically, at 2DF daily on 18Jan2021 and at 2 DF each day through on 19Jan2021; vitamin D3; fish oil; ascorbic acid (VITAMIN C) and cyanocobalamin (VITAMIN B12). The patient experienced chest soreness/pain, pain with breathing/hurt to breathe, severe fatigue, soreness at injection site, on 14Jan2021 (as reported). Events were also described as follows: patient prophylactically took 2 ibuprofen 30 minutes before vaccine on 18Jan2021 at 08:30 am and got the vaccine on 18Jan2021 at 9am. She just had soreness at injection site that evening. She kept up with the ibuprofen (only 2 doses each day) through on 19Jan2021. On 21Jan2021 she felt severe fatigue and later in the evening she started to feel chest soreness/pain and pain with breathing. It felt muscular but she went to emergency department (ED) because it hurt to breathe. They did a cardiac and PE work up which was negative. The pain was relieved by Toradol IV. She was discharged from emergency department (ED) . She took more ibuprofen on 22Jan2021 when she started to feel the same, but lesser, symptoms and the pain went away. On 23Jan2021, so far patient felt okay. The final outcome of the events was reported as recovering.; Sender's Comments: Based on the temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the events "chest soreness/pain, pain with breathing/hurt to breathe". The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
56 2021-02-05 chest discomfort Received dose #2. That evening, developed headache and dizziness, arm pain. 1/7-arm pain radiating d... Read more
Received dose #2. That evening, developed headache and dizziness, arm pain. 1/7-arm pain radiating down the ribs, extreme fatigue, body aches, dull headaches. 1/8- chest tightness, temp 99.8, body aches, fatigue, dull headache. Only able to dose with Tylenol. 1/12-follow up: states doing well and all symptoms subsided.
56 2021-02-07 fast heart rate Tachycardia; shortness of breath; rigors; muscle pain; fatigue; headache; This is a spontaneous repo... Read more
Tachycardia; shortness of breath; rigors; muscle pain; fatigue; headache; This is a spontaneous report from a Contactable consumer (patient). A 56-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=Fl3249), via an unspecified route of administration in left arm on 19Jan2021 13:00 at first single dose for COVID-19 immunization. Medical history included high cholesterol, gastrooesophageal reflux disease (GERD), dry eye syndrome, covid-19 (covid prior vaccination). Known allergies: No. Concomitant medication included atorvastatin, fish oil, pantoprazole. No other vaccine received in four weeks. The patient experienced tachycardia, shortness of breath, rigors, muscle pain, fatigue, headache, on 20Jan2021 02:30 AM. Events resulted in: Emergency room/department or urgent care. Events treatment inluded: Fluids, tylenol, clonazepam. Covid was not tested post vaccination. Outcome of the events was recovering.
56 2021-02-08 fainting Pt states she had pain in deltoid, scapula, trap and interscalenes, states it started after the surg... Read more
Pt states she had pain in deltoid, scapula, trap and interscalenes, states it started after the surgery. Pt continues to have this pain 4 days out. Pt had two syncopial episodes at home, I spoke with her pcp and this is normal reaction for her to vaccines. Pt has had fever ranging from 101 to 104 for past 4 days since the second dose of her covid vaccine.
56 2021-02-11 oxygen saturation decreased Anaphylaxis, itching, tightness of the throat, shortness of breath, low oxygen levels Treatment: 1... Read more
Anaphylaxis, itching, tightness of the throat, shortness of breath, low oxygen levels Treatment: 1 Benadryl 1130am, 1 Epipen 1155am, 1 Epipen 1225, steroids intravenously 1pm Outcome: Released home
56 2021-02-14 haemoglobin decreased, platelet count decreased Pt received dose #1 of COVID-19 vaccine (Pfizer-BioNTech) on 12/18/20 and dose #2 ( Pfizer-BioNTech)... Read more
Pt received dose #1 of COVID-19 vaccine (Pfizer-BioNTech) on 12/18/20 and dose #2 ( Pfizer-BioNTech) on 1/8/21. On 1/30, patient was evaluated at urgent care due to back pain. No bloodwork done; metronidazole prescribed for 7 days. On 2/8, patient was admitted to outside hospital due to ongoing symptom progression. At time of admission, hgb 5 g/dL and plt 9k. Per Dr. (hematology/oncology), pt with schistocytes, LDH 1500, and elevated reticulocyte count consistent with thrombotic thrombocytopenic purpura (TTP). SCr >2 mg/dL. Patient immediately treated with plasma exchange and steroids, however continued to decline. Patient expired on 2/14/21.
56 2021-02-21 blood glucose increased After vaccine in the waiting area, my blood sugar went up to 250 and that was after drinking water o... Read more
After vaccine in the waiting area, my blood sugar went up to 250 and that was after drinking water only since the night before and no food. I stayed about 1/2 hour, no one could say if this happens, About 12:30 or 1pm I wanted to sleep and slept 4 hours. The next dayi experience sensitivity to light sound headache nausea dizzy and ringing in the ears. I had to take off work at 12:30 and every since then I have had a headache after trying to work only a few hours. I couldn't keep my head set on, cant talk or train because the headaches are too bad. My doctor prescribed Imitrex. The Imitrex didn't even tough the headache, it just made me tired.
56 2021-02-21 nosebleed, hypertension Nosebleeds with elevated blood pressure began at 7:00 am on February 14, took 45 minutes to control ... Read more
Nosebleeds with elevated blood pressure began at 7:00 am on February 14, took 45 minutes to control at home, 2nd nosebleed February 15 at 5:00 am took 45 minutes to stop at home, saw PCP at 10:00 am, referred to ENT, February 16 nosebleed at 5:00 am, went to ER at 8:00 am, applied Afrin and TXA, February 17 Midnight nosebleed back in ER at 1:00 AM, silver nitrate used to cauterize 2 spots on right side of nose, February 17 10:00 PM nosebleed stopped after 45 minutes starting bleeding again at 1:00 AM went to ER recauterized one spot. February 18 appointment with ENT cauterized several areas with silver nitrate, February 21 10PM nosebleed again went to ER per ENT instructions, stopped bleeding, they put in afrin, got home Februray 22 1:00 AM bleeding started again applied afrin and pressure, stopped 30 minutes later. Appt with PCP February 22 at 10:00 am
56 2021-02-21 heart rate increased Pt had a reaction to PFIZER vaccine felt flush and dizzy and fast heart rate, Emergency room was cal... Read more
Pt had a reaction to PFIZER vaccine felt flush and dizzy and fast heart rate, Emergency room was called to transport pt to ED and pt was given a epi pen in observation area where pt received epi pen, pt vitals were BP Right arm: 135/81 HR:117 O2 SAT: 100% on RA 9:18AM 56 y.o. female with a past medical history of hypothyroidism, GERD, anxiety, and Hashimoto's thyroiditis (on levothyroxine) presenting with reported allergic reaction. Patient reports that she had received the COVID vaccine today and 10 minutes later, started to have room-spinning dizziness to the point that she thought she was going to fall out of her chair. She also reports that she started to shake, had shortness to breath, and felt her heart rate increase. Patient had notified staff at the vaccination center and was immediately administered an Epi pen to her left thigh and brought down to the ED. She states that she then started "twitching everywhere" and notes chills as well as a scratchy throat, which are still present. She denies any previous similar symptoms as well as any feelings of anxiety prior to the vaccine or difficulty breathing. She reports an allergy to bees and seasonal allergies, but denies any other known drug allergies. No evidence of anaphylaxis or airway compromise. Discussed rebound potential; feel home observation reasonable. Instructed on antigen avoidence. Patient reports she received the vaccine and epinephrine around 9am. She was observed in the ED for 4 hours post injection without complication. Reports shakiness and tingling after epi has resolved. Patient feels better by 1pm and goes home.
56 2021-02-22 chest discomfort Chest tightening; moist non productive cough; tightening of the throat; facial flushing; hot flashes... Read more
Chest tightening; moist non productive cough; tightening of the throat; facial flushing; hot flashes; This is a spontaneous report from a contactable nurse. A 56-year-old female patient received second dose of bnt162b2 (Brand: Pfizer, Formulation: solution for injection, Lot number: EL3302) via intramuscular, on right arm on 02Feb2021, 10.30 at single dose for COVID-19 immunization. The medical history included allergies to bees and nickel, GERD (Gastro-oesophageal reflux disease). The concomitant medication included diphenhydramine hydrochloride, paracetamol (TYLENOL PM) on an unknown date in 2021. The patient previously received historical vaccine, first dose of bnt162b2 (Brand: Pfizer, Lot number: EL0140) via intramuscularly on left arm at 9.30 on 12Jan2021 for COVID-19 immunization. It was reported that at 10.45 on 02Feb2021, the patient experienced chest tightening, moist non-productive cough, tightening of the throat, facial flushing, hot flashes. The patient was not pregnant at the time of vaccination. The patient received most recent COVID-19 vaccine at nursing home/senior living facility. The patient didn't receive any other vaccine within 4 weeks prior to the COVID vaccine. The patient received Tylenol Pm within 2 weeks of vaccination. The patient visited emergency room for the events. Therapeutic measures were taken because of events via oral and subcutaneous. The patient had not diagnosed with COVID-19 prior to the vaccination and since the vaccination. The outcome of the events was recovered on an unknown date in 2021.; Sender's Comments: The association between the events chest tightening, moist non-productive cough, tightening of the throat, facial flushing, hot flashes with BNT162B2 use can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
56 2021-02-23 chest discomfort Patient complained of heaviness in chest and lightheaded. Patient remained in observation for and a... Read more
Patient complained of heaviness in chest and lightheaded. Patient remained in observation for and additional 30 minutes before leaving the site.
56 2021-02-23 palpitations Patient felt dizzy and nervous prior to receiving vaccination. After vaccination, patient reports h... Read more
Patient felt dizzy and nervous prior to receiving vaccination. After vaccination, patient reports her heart was racing and still feeling dizzy. EMS onsite and pulse was 90, BP of 170/88, patient was taken to hospital for further evaluation.
56 2021-02-23 loss of consciousness Prior to receiving vaccine, vaccinator stated patient had increased ?anxiety? making statements such... Read more
Prior to receiving vaccine, vaccinator stated patient had increased ?anxiety? making statements such as ?I?m going to die! This vaccine is going to kill me!? Immediately after receiving vaccine (less than 3 seconds) patient slumped down in chair, writer to the patient, patient stating ?I can?t breathe, its going dark, I?m going to die! What about my daughter!? Writer and vaccinator attempted to talk patient down, ineffective. Patient V/S 100/60, 66-HR, 98%-O2, 22-Resp. Patient became limp in chair, unresponsive, episode of urinary incontinence, EMS activated. ~90 seconds into episode patient regained consciousness, A&Ox4, stating ?I?m back. I?m back.? Patient reports this last happened to her ?in college?. Patient also states ?my doctor told me not to get the vaccine, to wait until August since I have Lyme Disease.? Patient to ED with EMS.
56 2021-02-24 chest pain Chest pain, difficulty breathing, tingles in the face, tongue swelling, cold sweats
56 2021-02-24 chest discomfort, chest pain Tightness in my chest like a panic attack - I've never had one but this is what it seemed like. I wo... Read more
Tightness in my chest like a panic attack - I've never had one but this is what it seemed like. I would deep breath to calm down. Took my Pulse/O2 and it was 98% and 62BPM and BP was 107/58 that day (6 Feb). Took it the next day and we had a 98% and BPM of 58 and BP went to 148/72 ( very unusual for me). 4 days later took Pulse/O2 at 98% 58BPM and BP at 120/62. I feel pain in the center of my chest where my heart is and I have never had this in my life until 2 days after the vaccination. I am now taking a lung support (Clear Lungs - Nutritional Therapeutics) in case I have a lung issue. I live at 5000' and can walk and I now only do light exercise so I don't feel the heaviness or "stress" feeling in my heart. I have not gone to the dr yet. On 8 Feb my chest was really hurting and did feel some pain on my lower jaw and this went on for about 2 hrs. I did not go to the hospital. Something is wrong since getting this shot even though the symptoms are subsiding. Again, for someone without comorbidities or a history of her heart ever hurting to have this happen 1 1/2 days after the vaccine is not a coincidence and from all data that can be found this is an anomaly. I am troubled and concerned about my reaction.
56 2021-02-25 chest discomfort, blood glucose increased, blood pressure increased, chest pain Progress Notes APRN (Nurse Practitioner) ? ? Family Medicine Pt called for follow up s/p covid-19... Read more
Progress Notes APRN (Nurse Practitioner) ? ? Family Medicine Pt called for follow up s/p covid-19 vaccine done on 02/24/21. She was sent to the ED from here for further evaluation of chest pain. She states her bp continued to be elevated but they gave her an anti-inflammatory shot for her chest pain. States it helped a little but not much. States last night was "rough" but got better through the night and "honestly I didn't feel better until noon today." Took her bp today and it was 148/98. She has not contacted her pcp for follow up. She was reminded to continue to track her bp and record. It was also recommended that she contact her pcp tomorrow to get in sometime next week to be further evaluated and f/up on bp. She is aware of when to return to ED for worsening or new symptoms discussed today. Pt voiced appreciation for the phone call/follow up. Denies any other questions or concerns. Progress Notes APRN (Nurse Practitioner) ? ? Family Medicine Cosign Needed Attempt to call patient for follow up via phone. No answer. Progress Notes APRN (Nurse Practitioner) ? ? Family Medicine Cosign Needed Date: 2/24/2021 Subjective Pt is a 56 y.o. female who was seen at clinic today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the right deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience chest tightness. She denied rash, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, facial swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , chest pain, hypotension, rapid progression of symptoms, respiratory distress and tongue swelling. PMH: DM and HTN. She was taken off Actos here in the last couple of weeks and switched over to Glipizide. She also takes 10 mg of Lisinopril at night time. She also takes Morphine BID for chronic pain. ALLERGY REVIEW OF SYSTEMS: Patient complains of chest tightness and dizziness Patient denies chills, fever, malaise/fatigue, sore throat, frequent throat clearing, cough, shortness of breath, wheezing, rash, hives, eczema, itching of skin, abdominal pain, muscle aches and headaches Previous Reactions: none Objective Vitals Vitals: 02/24/21 0915 02/24/21 0928 02/24/21 0939 02/24/21 0945 BP: (!) 155/82 (!) 159/93 (!) 154/79 (!) 156/88 BP Location: Left arm Left arm Left arm Left arm Patient Position: Sitting Sitting Sitting Sitting Pulse: 87 SpO2: 99% Blood Sugar 185 collected at 0915 Physical Exam Constitutional: General: She is not in acute distress. Appearance: Normal appearance. She is well-developed. She is obese. She is not ill-appearing or diaphoretic. HENT: Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. Eyes: Conjunctiva/sclera: Conjunctivae normal. Neck: Thyroid: No thyromegaly. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing. Musculoskeletal: Right lower leg: No edema. Left lower leg: No edema. Skin: General: Skin is warm and dry. Neurological: Mental Status: She is alert and oriented to person, place, and time. Psychiatric: Mood and Affect: Mood is anxious. Behavior: Behavior normal. Thought Content: Thought content normal. Judgment: Judgment normal. Assessment/Plan Treatment included: antihistamines and water Follow up response to treatment: fair. Patient discharge: Transported to ED by POV. Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health) and Red flag symptoms (CP, SOB, NVD, Visual/Neuro concerns) During her stay she was monitored. After zyrtec was administered and she was laying down. She reported to feel a little better. Upon ambulation to evaluate, she reported lightheaded and chest tightness worsening slightly. She states she has her husband out front who is "angry with me for even being here." We discussed reasons for further evaluation as I am limited here. She declines Ambulance and states her husband won't take her but she would take herself or find a friend. Pt stable. Taken out in wheelchair. Pt ambulates without assistance. 2/24/2021 11:11 AM
56 2021-02-25 nosebleed Woke up the next morning and she felt numbness in her ear. She could hear, but it felt muffled. As... Read more
Woke up the next morning and she felt numbness in her ear. She could hear, but it felt muffled. As the day went on she realized that her ear was ringing. It started as a buzzing and now a high pitched ringing that she still has in her left ear. She also had a nose bleed that occurred twice on her right nostril. She has had nose bleeds in the past, but none recently. She was sitting working and her nose just started bleeding. The vaccine site itself was sore, minor and not unbearable. It's just the humming and buzzing in her ear that will not go away.
56 2021-02-26 low blood oxigenation Developed fatigue, cough, and shortness of breath 1 day after 2nd dose of vaccine. Started on anti... Read more
Developed fatigue, cough, and shortness of breath 1 day after 2nd dose of vaccine. Started on antibiotics and steroids empirically prior to admission 02/15. Initial CT with diffuse centri-lobular tree and bud opacities. Infectious (including BAL) and autoimmune work-up without clear explanation for infiltrate. Underwent VATS wedge resection for tissue diagonsis. Post-op developed hypoxia requiring up to 10L O2 and worsening infiltrates on CT in a pattern consistent with organizing pneumonia (possibly drug reaction). Started empirically on steroids for concern for organizing PNA/hypersensitivity pneumonitis. Pathology returned with organizing pneumonia with increased eosinophils. Timing of onset of symptoms is concerning for a hypersensitivity reaction to the COVID vaccine. Symptoms are improving with steroids (started 02/26). Recovery to be determined but I am optimistic for a good recovery.
56 2021-02-27 palpitations Dyspnea, heart palpitations, cleared by EMS
56 2021-02-28 chest pain Achy no fever chills couldn't breathe anxiety chest hurts.
56 2021-02-28 palpitations Shortness of breath; heart palpitations; Muscle soreness (left arm); overall unwell feeling; This is... Read more
Shortness of breath; heart palpitations; Muscle soreness (left arm); overall unwell feeling; This is a spontaneous report from a contactable consumer (patient). A 56-years-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL 9262 and expiration date: unknown), via an unspecified route of administration on the left arm on 27Jan2021 at 09:15 at a single dose for COVID-19 immunization. Medical history included systemic lupus and shrimp allergies. The patient had no other vaccine in four weeks and no other medications in two weeks. There were no concomitant medications. The patient had no COVID prior vaccination. The patient experienced muscle soreness (left arm), heart palpitations, shortness of breath and overall unwell feeling on 27Jan2021 at 10:00, which resulted in a doctor or other healthcare professional office/clinic visit. No treatment was administered for the events. The patient has not tested for COVID post vaccination. The events were resolving.
56 2021-02-28 blood pressure decreased, heart rate decreased, loss of consciousness almost passed out; dizzy; clammy; hot; kept taking my Blood Pressure and pulse ox. Both very, very ... Read more
almost passed out; dizzy; clammy; hot; kept taking my Blood Pressure and pulse ox. Both very, very low; kept taking my Blood Pressure and pulse ox. Both very, very low; This is a spontaneous report from a contactable other healthcare professional. A 56-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot: reported as 96.8), via an unspecified route of administration in the left arm on 31Jan2021 14:15 at a single dose for covid-19 immunization. The patient's medical history included Lupus, Fibro, Hyperthyroidism, Hashimoto's, IBS all from an unknown date. Patient has no known allergies. Concomitant medication included pantoprazole, xylometazoline hydrochloride (SUDAFED [XYLOMETAZOLINE HYDROCHLORIDE]), vitamin c [ascorbic acid], vitamin d3 and calcium (CALCIUM). 15 minutes after the shot while waiting, 8 minutes into it the patient felt dizzy, clammy, hot, and almost passed out. Nurse gave patient oj, oxygen, Epipen, checked sugar, and kept taking her blood pressure and pulse ox. Both very, very low until it came back up within 20 minutes. The patient declined hospital due to feeling better. Called the doctor next day to discuss what happened. She recommended no 2nd shot. The outcome of the events was recovered. The patient has not had Covid prior to vaccination and patient has not tested post vaccination.
56 2021-02-28 palpitations legs cramps; stomachaches; has a history of heart palpitations/she felt her heart started rushing mo... Read more
legs cramps; stomachaches; has a history of heart palpitations/she felt her heart started rushing more, she had rapid heartbeat; sore arm; This is a spontaneous report received from a contactable consumer (patient). A 56-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283, expiry date: unknown), via an unspecified route of administration on the left arm, on 09Jan2021, at single dose, for COVID Prevention/COVID-19 immunization. Medical history included heart palpitations. Concomitant medication included unspecified medication for heart palpitations. The patient did not receive any other vaccines on the same day as BNT162B2. On 09Jan2021 (the same day as the patient received the vaccine), she developed sore arm which went on about for three days. The patient reported she put rubbing alcohol on it and that helped. On 12Jan2021 (day three after the vaccine), the patient experienced leg cramps and stomachache which went on about for 24 hours. The patient reported that she has a history of heart palpitations, but when she got the vaccine, on 12Jan2021 (day three after the vaccine), she felt her heart started rushing more, she had rapid heartbeat, but then she got it under control. She reported she has some pills for that, so she took an extra dose of her pills and that helped out with the palpitation. The patient recovered from the event sore arm on 12Jan2021; from leg cramps and stomachaches on 13Jan2021; and from "has a history of heart palpitations/she felt her heart started rushing more, she had rapid heartbeat" on an unspecified date.
56 2021-03-02 chest discomfort, heart rate increased, fast heart rate 12/18 1st vaccination 12/27 COVID + 1/10 2nd vaccination Later that evening, I had tightness on R s... Read more
12/18 1st vaccination 12/27 COVID + 1/10 2nd vaccination Later that evening, I had tightness on R side chest. Rapid HR. Pulse 144. Lasted 3-4 minutes. Called 911. HR had gone back down to 78, normal BP, normal EKG. Tachycardia 1/11 lymph nodes swollen under armpit on R side. Sore arm. Had another episode 2 days later; Tachycardia. Went to Dr 1/13/2021. Full work up. Started on BP medicine.
56 2021-03-02 excessive bleeding Bleeding upon injection; large bruise; extreme nausea; chills; fatigue; headache; This is a spontane... Read more
Bleeding upon injection; large bruise; extreme nausea; chills; fatigue; headache; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9261) solution for injection, via an unspecified route of administration at right arm on 11Feb2021 at 4:15 PM at single dose for COVID-19 immunization. Medical history included allergies to penicillin, glaucoma (reported as glaucomo) and high blood pressure. Concomitant medication included metroprolol. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), via an unspecified route of administration at right arm on 20Jan2021 at single dose for COVID-19 immunization. The patient was not pregnant. The vaccine was administered at a hospital. There was no other vaccine in four weeks. The patient was no COVID prior to vaccination and she was not tested for COVID post vaccination. The patient experienced bleeding upon injection, large bruise, extreme nausea, chills, fatigue, and headache, all on 12Feb2021 at 04:00 AM. She did not receive any treatment in response to the events. The outcome of the events was recovering.
56 2021-03-02 blood pressure increased VOMITING for two days after shot and ondansetron prescribed, SWOLLEN GLANDS ON LEFT SIDE NECK AND CL... Read more
VOMITING for two days after shot and ondansetron prescribed, SWOLLEN GLANDS ON LEFT SIDE NECK AND CLAVICAL AREA, NUMBNESS IN HANDS AND FINGERS, RAISED BLOOD PRESSURE, 103F FEVER on DAY AFTER SHOT
56 2021-03-03 fainting, blood pressure decreased Extreme Body aches, extreme headaches, extreme chills, fever 105.2, pain in the arm, dizziness, nau... Read more
Extreme Body aches, extreme headaches, extreme chills, fever 105.2, pain in the arm, dizziness, nausea, fainted at 6 pm on 02/27/21,, no response or movement. Blood pressure dipped down to 60/42 ...Ambulance came. EMT measured the blood pressure... 60/42 Was taking Tylenol 2 tablets of 500 mg. (max out) Fever will go down for an hour but would be back with extreme chills. Symptoms Fever, chills, body aches persisted for 30+ hours.
56 2021-03-03 heart rate irregular, chest pain, chest discomfort Systemic: Chest Tightness / Heaviness / Pain-Medium, Additional Details: Within 10 minutes of receiv... Read more
Systemic: Chest Tightness / Heaviness / Pain-Medium, Additional Details: Within 10 minutes of receiving vaccine, patient reported chest pain feeling like a pinching/stabbing. We had trained EMTs along with pharmacists. Reported 5/10 pain. Patient has hx of high blood pressure, high cholesterol, arthritis, and angina. Heart rate taken and it was irregulaerly irregular but after given a dose of aspirin 324mg it was back in normal sinus rhythym. Gave IV NaCl and taken by rescue. on departure was symptom free. no SOB, hives or chest pain.
56 2021-03-04 blood clot Blood clot on thigh
56 2021-03-04 chest pain Pt had second dose of Pfizer vaccine at 09:20. Stated she had headache on left side and left-sided c... Read more
Pt had second dose of Pfizer vaccine at 09:20. Stated she had headache on left side and left-sided chest pain at 09:25. Not associated with other symptoms. Vitals taken BP=165/101 Resp=24 O2=100%RA,. Reported to EMS. Established IV, 4 81mg aspirin given. Pt placed on telemetry monitor. Pt states CP resolved prior to transport to hospital.
56 2021-03-14 hypertension, chest discomfort annoying feeling in her chest; allergic reaction; Her pressure was low then normal then high.; nonre... Read more
annoying feeling in her chest; allergic reaction; Her pressure was low then normal then high.; nonresponsive for a few moments/was asked a question and did not respond; sweats; high blood pressure; annoying pain; itching; hives on the arms and chest; Hot flashes; This is a spontaneous report from a contactable consumer (patient) A 56-years-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) from Lot# EN5318 at left arm on 16Feb2021 at SINGLE DOSE for covid-19 immunisation . Age at vacciantion 56 years.Vaccination Facility Type: Workplace Clinic. Medical history included ongoing allergies (5-10 years). She had a flu shot in Oct2020. There were no concomitant medications.Immediately after the vaccine she became nonresponsive for a few moments, broke out in sweats, had high blood pressure, annoying pain, and has been having itching and hives on the arms and chest.Clincal course was reported as follows: On 16Feb she had hot flashes,pruritus and blood pressure has not been right .On17Feb she developed annoying feeling in her chest.Then , it was added as follows: she received the first dose of the Covid-19 vaccine on 16Feb2021. She had an allergic reaction. The second dose was due 09Mar2020. She was under the impression that she has to take the vaccine she was told she needed a cocktail to get the shot.She had hot flashes and was itching. Her blood pressure has not been right. Her pressure was low then normal then high. She has an annoying feeling in her chest. The itching has stopped after she was medicated. She can't take Benadryl and she was given something else. She applied hydrocortisone cream and it helped. She had a flu shot in Oct2020. She went to the ER on 20Feb2021 because her blood pressure was spiking too high. She had an EKG which was normal. When she went to the ER her blood pressure was 167/100. Yesterday her blood pressure was 167/102. She was nervous about taking the second dose. Her blood pressure usually ranges from 119-120. It was off the charts at 130/80 and 150/99. Pateint was treated for pruritus.She was wondered if she can get the second dose .Events reported as non serious.Lab data included:EKG on20Feb2021:normal.Blood pressure measurement (16Feb2021): has not been right. Her pressure was low then normal then high , blood pressure measurement: 167/100 on 20Feb2021 , blood pressure measurement: 167/102 on 24Feb2021.Patient's recovered from pruritus while the outcome of the other events was unknown.
56 2021-03-17 chest pain, blood clot blood clot leading to brain stem stroke, intubation, shortness of breath and chest pain
56 2021-03-18 heart rate irregular LOSS OFBLADDER CONTROL; IRREGULAR HEARTBEAT; This is a spontaneous report from a contactable other h... Read more
LOSS OFBLADDER CONTROL; IRREGULAR HEARTBEAT; This is a spontaneous report from a contactable other hcp. A 56-year-old female patient started to receive bnt162b2 (BNT162B2, Solution for injection, Lot # EL9261), via an unspecified route of administration from 29Jan2021 to 29Jan2021 at SINGLE DOSE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On Jan2021, the patient experienced loss of bladder control, irregular heartbeat. The action taken in response to the event for bnt162b2 was not applicable. The outcome of the event was not recovered.
56 2021-03-24 blood pressure decreased dehydrated; shaking; bowel movement that was loose but not like it was, not diarrhea; she had a litt... Read more
dehydrated; shaking; bowel movement that was loose but not like it was, not diarrhea; she had a little bit of something in her bladder, in her urine; she had a little bit of something in her bladder, in her urine; woke up completely drenched; Blood pressure dropped; Vomiting; nauseated and couldn't eat; nauseated and couldn't eat; high fever/ It got to over 103; Diarrhea is like a greenish color; diarrhea; Chills; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration at the age of 56-years-old, administered in Arm Right on 03Mar2021 15:00 (Lot Number: EN6204; Expiration Date: 30Jun2021) as single dose for COVID-19 immunization. Medical history included kidney and pancreas transplant patient since 01Apr2014 (On 01Apr2021, will be seven years since her transplant), Gastroparesis from 2005, Small intestinal bacterial overgrowth from 2019 (hasn't had any issues with that in over a year), Diabetic macular edema (Doesn't think Diabetic macular edema pertains to anything with the COVID Vaccine), pacemaker in her stomach (Procedure for pacemaker for stomach performed first time in 2006. Stomach pacemakers only last eight to ten years. Had the battery replaced in 2017), she had previously had C-Diff, high blood pressure (Doesn't have high blood pressure anymore), immunosuppressed. The patient's concomitant medications were not reported. Patient states about a week ago, she talked to someone at clinic, reporting after she got the first dose of the Pfizer COVID 19 vaccine. She had reported she had diarrhea. Clarifies she got her vaccine on 03Mar2021 at 15:00PM in the right arm. She previously reported she started having diarrhea in the night, Thursday (04Mar2021), and had it for ten days. At that time, when she had reported, she only had diarrhea. Diarrhea is like a greenish color. Has been trying not to eat heavy things, but diarrhea is still a greenish color. She contacted her stomach doctor and he wanted her to do a COVID 19 test, which was negative; and a whole stool work up because she had previously had C-Diff. She did all that and turned it in Friday. Adds she did have the chills a little on the day of the vaccine but they went away. Reporting new events today including on 13Mar2021 she started having a fever. It got to over 103; she was so nauseated she couldn't eat (13Mar2021); with chills (03Mar2021) and shaking (unspecified date). She treated the fever with Tylenol and got some relief but then her fever would go back up. She thinks she was getting dehydrated (Mar2021) from all the diarrhea and then she started to throw up on Tuesday (16Mar2021). That day she was admitted to the hospital, 16Mar2021. At the hospital they did another COVID 19 test that was negative; blood tests; urine test; US kidney; CAT Scan whole stomach; and they could not find anything that could cause her symptoms. Adds they did say she had a little bit of something in her bladder, in her urine (unspecified date). While hospitalized she was treated with IV antibiotics; Phenergan and Zofran which controlled the nausea and vomiting. Her fever went down to 99 by Friday. Adds she did have one episode on Friday of low blood pressure (19Mar2021) and they were watching it. She was discharged on Saturday and has not had a fever since she came home. Adds she did have a bowel movement that was loose but not like it was, not diarrhea (unspecified date). Mentions for the last two nights she woke up completely drenched (20Mar2021) but she did not have a fever. Adds she felt a little chill last night, but she just covered up with her blanket. She feels her dehydration is improving. Therapeutic measures were taken as a result of dehydrated, high fever/ it got to over 103 (pyrexia), vomiting, nauseated and couldn't eat. The outcome of dehydrated was recovering, diarrhea and diarrhea is like a greenish color was recovered on 18Mar2021, high fever/ it got to over 103 was recovered on 19Mar2021, chills was not recovered, vomiting recovered on 17Mar2021, nauseated and couldn't eat recovered on 18Mar2021, blood pressure dropped recovered on 19Mar2021, woke up completely drenched was not recovered, and all other events was unknown. The patient was hospitalized for dehydrated from 16Mar2021 to 20Mar2021.
56 2021-03-27 loss of consciousness blacked out or fell asleep while driving to work the next morning which resulted in a car accident; ... Read more
blacked out or fell asleep while driving to work the next morning which resulted in a car accident; no recall of driving; extreme confusion during the day. Heaviness in head for several days; fatigue for several days
56 2021-03-29 chest discomfort, hypertension The vaccine site was Community Center being done by Paramedics and Fire Fighters. I received the vac... Read more
The vaccine site was Community Center being done by Paramedics and Fire Fighters. I received the vaccine and sat down in the chairs to wait the required 15 minutes. Within 2-3 minutes my face got very hot. I could feel the heat under my mask. Another minute or two, just below my knees to my toes started tingling. Another two minutes or so, I felt like my eyes were swelling. I took my glasses off and looked at my husband and asked if my eyes are swelling, he said, they sure are and called over one of the paramedics that were there. They directed me to a more private are and put me on a monitor and monitored my vital signs. My blood pressure which is well controlled on my meds (which I did take that morning) climbed and climbed to 200s/100s. My chest was tight and uncomfortable and getting more difficult to breath. They put and 02 mask on and gave me Benadryl IM. By that time the squad was there and took me to the local hospital ER. In the squad my tongue started to swell. At the hospital they gave me Solumedrol IV which took care of it all. The swelling quickly went away in my tongue and face, the chest pressure went away, and all the other little annoyances like the tingling. The hospital did a chest x-ray and bloodwork. I went home after 3-4 hours with a prescription for Prednisone 50 mg daily for 5 days. No further reactions after that.
56 2021-03-30 hypotension Shortly after vaccine administration, the pt honked her car horn for help and was noted to be minim... Read more
Shortly after vaccine administration, the pt honked her car horn for help and was noted to be minimally responsive. Initial BP was noted to be 60/palp. She was promptly given a dose of epi (epipen) at appx. 0830. She did not improve immediately and required a second dose of epi. Prior to transport by EMS, she improved slightly and denied any respiratory symptoms or skin involvement. She complained of feeling weak and tired only. SP02 was 89% and HR was in the 70s and regular. 02 was administered by EMS and she was given a dose of Benadryl, 25mg as well. While EMS was still on scene with the pt, BP improved to 130 systolic and she was noted to be significantly improved. She had a significant period of hypotension for appx. 20 minutes however (prior to improvement). Unclear if she had a prolonged vasovagal response or possibly anaphylaxis. She did not have clear mucosal, respiratory or GI involvement to suggest a definite diagnosis of anaphylaxis. She was transported to local ER by EMS in improved condition.
56 2021-03-31 palpitations she wakes herself up with anxiety; Heart racing; felt like she was clunked over the head; she was ti... Read more
she wakes herself up with anxiety; Heart racing; felt like she was clunked over the head; she was tired and sleepy; she was tired and sleepy; right thigh area in the muscle feels throbbing and pain; Fluttering Heart Beat; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two patients. This is the first of two reports. A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in the right arm on 18Mar2021 at 08:15 (batch/lot number: ER2613) as a single dose for COVID-19 immunisation (also reported as "preventing COVID-19 virus"). Medical history included ongoing rheumatoid arthritis diagnosed 15 years ago, type 2 diabetes from Jun2019 and ongoing, and ongoing high blood pressure diagnosed about 25 years ago. Concomitant medications included adalimumab (HUMIRA) taken for rheumatoid arthritis from 2020 (started it a year ago) and ongoing; insulin detemir (LEVEMIR) taken for type 2 diabetes from 2019 and ongoing; insulin aspart (NOVOLOG) taken for type 2 diabetes from 2019 and ongoing. The patient previously took tofacitinib citrate (XELJANZ) prior to adalimumab. The patient stated that she has a question. She received her first dose today at the in (City name). Stated they gave out a fact sheet upon leaving after vaccine. She stated the sheet stated that she should mention if she was immunocompromised or on medication that compromises the immune system. Asked should she be expecting something different. Stated no one asked her or told her before she got the vaccine. On 18Mar2021, she stated that she felt a fluttering heart beat that lasted for a half hour. She stated that she got the vaccine at 08:15, and about a half hour after (08:45) that she had a racing heart. She stated that she felt like she was clunked over the head, she was tired and sleepy but that has passed. She stated that her brother mentioned he had this too after his vaccine but resolved. Stated her right thigh area in the muscle feels throbbing and pain, nothing excruciating. Stated it was nothing to notice, her brother said he felt the same thing after his vaccination 2 days ago. For the event fluttering heart beat, stated that she had to sit down because she didn't know what was happening but it went away. For the event right thigh area in muscle throbbing and pain, stated it could be muscle of thigh, pain throbbing, not injection site. For the event tired and sleepy, stated that when she got home she first wanted to lay down and take a nap but thought she needed to stay awake. Stated sometimes she wakes herself up with anxiety or maybe it was side effects but she felt like she was starting to come around. She stated that she only has 10 minutes before she needed to walk out the door for an appointment. She still wanted to speak with Medical Information so she wanted to be transferred since she doesn't have much time before she needs to go. The outcome was recovered on 18Mar2021 for the events "fluttering heart beat" and "heart racing", and recovering for the rest of the events.; Sender's Comments: Linked Report(s) : PFIZER INC-2021307886 same reporter/drug/events, different patient
56 2021-04-02 blood pressure increased her throat itches; she could not breath; her pressure raised to 230; throat started to close; This i... Read more
her throat itches; she could not breath; her pressure raised to 230; throat started to close; This is a spontaneous report from a contactable consumer (patient's husband). A 56-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported) at the age of 56-year-old, via an unspecified route of administration on 07Mar2021 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The husband commented that both of them got the first dose of the Pfizer covid vaccine on 07Mar2021 and some minutes later, the patient started having a reaction that she had to be taken into the ER with an ambulance: her throat started to close, she could not breath and her pressure raised to 230. Until today, she has not fully recovered, and they have been getting in and out of the ER, in fact they just arrived home from there. Physicians only prescribed antiallergy medications and the patient was still having the same problem and her throat itches on an unspecified date. The physicians they have consulted have contradictive opinions about how she should do: one recommended her not to get the second dose while another recommended her to get started again on the series. The husband wants to know what they can do about this. The outcome of the events was unknown. Information about lot/batch number has been requested.
56 2021-04-08 chest pain 57 y/o with Past Medical History of Rheumatoid Arthritis on Methotrexate and a biologic medication ... Read more
57 y/o with Past Medical History of Rheumatoid Arthritis on Methotrexate and a biologic medication completed her 15 minute observation period post administration of her 2nd Pfizer COVID vaccination. As she walked out and she began listing to the right side. She sat down, confused, and complaining of chest pain. She also noted pruritus over her face and scalp. No c/o Shortness of Breath, wheezing or nausea. She was immediately evaluated by me and EMT's . Vital signs demonstrated a HR of 74 in sinus rhythm, O2 Sat of 98% and BP was 192/104. She did not have a rash but was scratching at pruritic areas on scalp and face. See continuation page...
56 2021-04-10 heart rate increased, blood pressure increased, chest pain, blood glucose increased, fast heart rate sinking sense of doom-death; high heart rate; BP is spiking to 165/100; mile fever; sore arm; Severe... Read more
sinking sense of doom-death; high heart rate; BP is spiking to 165/100; mile fever; sore arm; Severe headache; blood sugar spikes of 200 fasting; Increased tahcycardiaI suffer from that) but it was more frequent and severe; chest pains; This is a spontaneous report received from a contactable consumer (patient) reported for herself. A 56-year-old female patient (patient was not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EM6199) via an unspecified route of administration, administered in Arm Left on 10Mar2021 at 12:00 at a single dose for covid-19 immunisation. Medical history included had covid from 30Jun2020. Concomitant medication patient received within 2 weeks of vaccination included Metoprolol ER 25 mg cyclic, Armour Thyroid 30 mg cyclic. The patient previously took fluoroquinolones and experienced known allergies. The patient reported that on 13Mar2021 on Day 3 of vaccine BP starts to go up. My average is 100/50. By day 4 BP is spiking to 165/100 with a mile fever and sore arm, and a sinking sense of doom-death). Severe headache and continued blood pressure spikes throughout week along with blood sugar spikes of 200 fasting. I'm not diabetic. Increased tahcycardiaI suffer from that) but it was more frequent and severe. Blood pressure spiked to 187/167, I took extra BP meds (which was low dose more for my tachycardia)to help with insane BP. Went to hospital and stayed for 2 days. No heart attack, Just insane BP with chest pains and high heart rate. Day 18 after shot and BP is going down and so is blood sugar. Every once in a while, it will spike to 160/100--last for about 1 hour and then drop to my normal BP before the shot. The events were considered serious with seriousness criteria hospitalization and medically significant. The patient was hospitalized for 2 days. Adverse events resulted in Emergency room/department or urgent care, Hospitalization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. No treatment was received for the adverse event. The patient underwent lab tests and procedures which included Nasal Swab: negative on 23Mar2021. The patient was recovering from all the events. Follow up needed, further information has been requested.
56 2021-04-12 nosebleed, heart rate increased elevated resting heart rate; dizziness; nausea; Injected arm went numb; bad stomach cramps; fever; s... Read more
elevated resting heart rate; dizziness; nausea; Injected arm went numb; bad stomach cramps; fever; smell altered on and off; taste altered on and off; muscle pain; headache; all over pain first 36 hours preventing sleep; a little bleeding from bowel at 24 hrs and nose at 36 hrs; Burning like fire at injection site; Hair follicle pain; a little bleeding from bowel at 24 hrs and nose at 36 hrs; extreme armpit pain like torn muscles; no use of arm first two days; fatigue; This is a spontaneous report from a contactable consumer (patient). A 56-year-old non-pregnant female patient received first dose of BNT162B2 (Covid shot, PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number ER 8733) via an unspecified route of administration at left arm on 27Mar2021 15:15 at a single dose for Covid-19 immunization. Medical history of patient was not reported. She did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included multivitamin, calcium and fish oil (other medications the patient received within 2 weeks of vaccination). Patient stated as injected arm went numb within 15 minutes and stayed that way 48 hrs, extreme armpit pain like torn muscles began at 48hrs, bad stomach cramps first 24 hours, a little bleeding from bowel at 24 hrs and nose at 36 hrs, no use of arm first two days could not even put a robe on, fever that climbed to 101.7 until breaking first 48 hrs, smell and taste altered on and off. Burning like fire at injection site 12 hours later that came and went in waves for another 36 hrs. Hair follicle paint at 12 hrs when headache started, headache lasting 72 hours, all over pain first 36 hours preventing sleep, nausea began within first hour lasting about 40 hours, muscle pain first 48 hrs, fatigue begins at 36 hrs and continues, elevated resting heart rate since first night, dizziness and light headedness from 1st hour. The patient underwent lab tests and procedures which included body temperature was 101.7 and heart rate was elevated (elevated resting heart rate since first night) on 27Mar2021. Prior to vaccination, the patient was not diagnosed with COVID-19 and also not been tested for COVID-19 after vaccination. The outcome of event was recovering.
56 2021-04-17 cerebrovascular accident bleeding on the brain; she had a stroke; couldn't hardly remember anything; smile was stuck; she's w... Read more
bleeding on the brain; she had a stroke; couldn't hardly remember anything; smile was stuck; she's walking, but her right leg is hard to lift up; still in a lot of pain; This is a spontaneous report from a contactable consumer. A 56-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration, administered in Arm Left on 22Mar2021 11:30 (at 56-year-old) as single dose for COVID-19 immunization. Medical history included ongoing high blood pressure. Vaccination Facility Type: Hospital. Concomitant medication included lisinopril (LISINOPRIL) taken for high blood pressure from an unspecified start date and ongoing. Caller states he is calling for his fiance, she's in the hospital. Caller states she had this vaccine done on the 22MAR2021 and had some side effects. Caller states she had a stroke (27Mar2021, hospitalized) and when he went online, he googled it about the shots, it actually said that COVID, the medicine, can cause the stroke, he actually watched a video about it. Caller states patient did good for two days then after two days, she woke up and couldn't remember hardly anything (25Mar2021, hospitalized) and he was questioning her like what month it was. Caller states he thought patient was playing with him, he waited a day and then her smile was stuck (25Mar2021, hospitalized) and when he got to the hospital, the doctor told him what happened. Caller states they actually want to keep her in a facility for therapy or rehab but she doesn't want to stay in the hospital and so they are seeing about getting therapy to come to the house. Caller states he works as a security officer. Prescribing Healthcare Professional: Caller states the healthcare she has is (state). Caller states he set up an appointment for her that she will be going. Caller states the patient hasn't gone there yet, she will be a new patient, on the 06 or 07. Caller states they are still at the hospital right now and all the information is at home. That doctor will be her new family physician. Caller states patient had the vaccine 22Mar2021 and she did good. Caller states then the next days she was not herself. He later clarified it was 25Mar2021 where she couldn't hardly remember anything, she was talking real funny. Caller states he's been around someone with strokes and he just wasn't sure so he told her he was going to take her to the hospital if she didn't get no better. Caller states she didn't get any better so she had bleeding on the brain (27Mar2021, hospitalized) and a stoke. Caller states the doctors told us what was going on and she was fine until she got the shot. Caller states it was about three days out from the shot. Caller states he would say she's not improving. Caller states the speech therapist came in, and wanted her to have therapy, they are really wanting to admit her. Caller states they told her she would have to get better. Caller states they talked to them about 40 minutes ago and he told them she didn't want to agree to that and they were trying to set it up where someone can come to the house for speech therapy and for her walking, she's walking but her right leg is still hard to lift up and just her memory, she doesn't remember her age. Caller states they said it could be up to six months before it gets better and if it don't, it's not gonna get better. Caller states on 27Mar2021, that's when they went to the ER and they did the CAT scan, that is when found out had a stroke and bleeding on the brain. Caller states he doesn't have the card she was given when she was received the shot, caller states that's at home. Outcome of stroke, bleeding on the brain, cannot remember anything : Caller states she has improved a little but everything is really about the same. Caller states she is still in a lot of pain and her memory's just not the same. Caller states they come in and they do tests on her, a word test, spelling test, she gets it right, she just has problems remembering her what her age is, what the month is, and what year it is. Caller states patient is supposed to get the second shot next week sometime, caller is unsure of the exact date. He mentioned he sees second dose it is within 2-3 weeks. No additional details provided. Caller states she was tested, they tested her there at the hospital, she just decided she wanted to get it. Caller states she didn't have the COVID any time. Caller states she had a CAT scan that showed bleeding on the brain and a stroke. Caller also reports she had a X-ray of the Chest, not sure of the results from that. Caller also states she had blood work done but doesn't know what it was or the results. Caller states he has to catch one of those doctors when they came in, but there was a lot of callers before him and they missed them. Time of Onset (24-hour clock) of Adverse Event was in the morning. Caller states they always get up, gets coffee started, 3-11 he does security. Caller states it was that morning, say around, she got up about 9:15AM (unspecified). It was also reported that she had Emergency Room visit. The outcome of the events she had a stroke, couldn't hardly remember anything, and bleeding on the brain was recovering; while for other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
56 2021-04-20 hypertension, loss of consciousness Blacked out; feel light headed; unbalanced; Having trouble to focus with my eyes; Head feels full; L... Read more
Blacked out; feel light headed; unbalanced; Having trouble to focus with my eyes; Head feels full; Lymph nodes in head, neck and under arms swollen; very high blood pressure; This is a spontaneous report from a contactable consumer or other non hcp. A 56-years-old non pregnant female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 17Mar2021 10:45 (Batch/Lot Number: EN6207) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient not received any other vaccines within 4 weeks prior to the COVID vaccine. Six days after the vaccine (on 23Mar2021 10:15 ), the patient started to feel light headed, unbalanced. Blacked out on March 23rd for a very short time. Having trouble to focus with his eyes. Head feels full. Lymph nodes in head, neck and under arms swollen. Very high blood pressure and now needing medication for that. These last two weeks have been a nightmare and thinking he was going to die and was in the Emergency room. No treatment was received for the events. Event blacked out seriousness was medically significant. The events outcome was not recovered.
56 2021-04-20 heart rate irregular, palpitations I have had heart palpitations and what feels like an irregular heartbeat. It began , I believe a da... Read more
I have had heart palpitations and what feels like an irregular heartbeat. It began , I believe a day or so after receiving the 1st Pfizer vaccine although I can?t recall with absolute certainty if it started just before or shortly after being vaccinated.
56 2021-04-21 hypertension 55 y/o female, with no past medical history, who presents with Right arm tingling post vaccination. ... Read more
55 y/o female, with no past medical history, who presents with Right arm tingling post vaccination. Patient states that this is her first dose in the two-dose series. Patient denies previous vaccination reactions. Patient received her vaccination to the Right arm. Patient states that she also feels anxious and nervous. Patient denies sore throat, difficulty swallowing, chest pain or difficulty breathing. NP and Paramedics at patient side. Patient provided with a bottle of water and legs were elevated. Within 3 minutes patient stated that tingling resolved. Patient noted to be hypertensive (172/104) with all other vital signs normal. Patient denies medical history of hypertension. Patient moved to the partitioned off area and placed on cot. Patient vitals monitored every 5 mins for 1 hour. Patient became normotensive and stated that symptoms had resolved. Patient discharged home in stable condition.
56 2021-04-27 chest discomfort Angioedema; chest tightness; SOB; This is a spontaneous report from a contactable nurse (patient). T... Read more
Angioedema; chest tightness; SOB; This is a spontaneous report from a contactable nurse (patient). This nurse reported similar events for different doses. This is the second of two reports. A 56-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: ER8734) administered in right arm on 07Apr2021 at 18:00 (at the age of 56-years-old) at single dose for COVID-19 immunisation. Medical history included prior history of idiopathic angioedema, several other antibiotics allergies - rash, hornet and wasp sting allergies; no chronic health conditions. Patient was not pregnant. No COVID prior vaccination; no COVID tested post vaccination. Concomitant medication included diphenhydramine hydrochloride (BENADRYL) taken at 50 mg for 3 for 12 hours pre-dose; no other vaccine received in four weeks. The patient previously took ZITHROMAX and experienced allergies - anaphylactic; the patient received the first dose of BNT162b2 (lot number: EP7534) on 17Mar2021 at 06:00 pm (at the age of 56-years-old) administered in the right arm for COVID-19 immunisation and experienced angioedema. The patient experienced angioedema, chest tightness, shortness of breath (SOB); initial reactions started around 12:00 noon on 08Apr2021, slowly continued to get worse throughout the day. Had to go to emergency room (ER) that evening. Angioedema reoccurred the following night and again on 10Apr2021. Another trip to ER on 10Apr2021 due to angioedema, chest tightness and SOB. The events were treatment with BENADRYL, SOLUMEDROL IV, PEPCID IV, nebulizer. The patient had recovered from the events in Apr2021.; Sender's Comments: Based on a positive temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported Angioedema, Chest Tightness and shortness of Breath. Consider also possible contributory effects from patient's medical history The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate. ,Linked Report(s) : US-PFIZER INC-2021330573 same patient, vaccine different dose
56 2021-04-28 blood pressure increased, palpitations heart rate 60bpm/Bradycardia; b/p 156/106; shortness of breath; series of palpitations; very light h... Read more
heart rate 60bpm/Bradycardia; b/p 156/106; shortness of breath; series of palpitations; very light headed; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, on Mar2021 14:00 (Lot Number: EN6207) at the age of 56-years-old, as a single dose in the left arm for COVID-19 immunisation. Medical history included hypertension, type 2 diabetes and hyperthyroidism. The patient had no other vaccine in four weeks. The patient's concomitant medication included other unspecified medications which she has been taking in two weeks. The patient previously received LEVAQUIN and NORVASC on unspecified dates and experienced allergies. The patient was not pregnant at the time of vaccination. The patient reported that two weeks after initial dosage, on 30Mar2021 she woke up at 2 AM to a series of palpitations. The patient's b/p (blood pressure) was 156/106, bradycardia/heart rate: 60 bpm, very light headed and with shortness of breath. The patient's normal average b/p was 125/85, sitting heart rate 80-85 bpm. The patient went to the emergency room (ER). Electrocardiogram (EKG) and chest X-ray results were nothing, she was sent home. The patient continued to have same symptoms for two weeks. After three more ER visits and 2 more EKG's, CT Scan on abdomen, 2 chest X-rays; multiple lab bloodwork including Troponin, two different cardiologist, Bluetooth heart monitor, echocardiogram even a gastroenterologist, thus far no explanation for bradycardia. The reported adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No treatment was received. The patient had no COVID prior vaccination. The patient was tested for COVID post vaccination which was a nasal swab/COVID-19 (STANDARD NAA) with negative result on 09Apr2021. The outcome of the events was not recovered. No follow up attempts are possible. No further information expected.
56 2021-04-28 excessive bleeding it was not liquid coming out of my rectum but a grey/taupe very soft stool; gassy; my stomach and ba... Read more
it was not liquid coming out of my rectum but a grey/taupe very soft stool; gassy; my stomach and back side were very pain full; sour belches; vomited; having dark liquid diarrhea pouring out of my rectum; I could not sleep; my entire stomach area was swollen and in extreme pain just to touch; my entire stomach area was swollen and in extreme pain just to touch; my back side was raw and bleeding; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in left arm on 08Apr2021 18:45 (Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included blood pressure (BP), sleeping, cholesterol. Patient had no covid prior vaccination. Concomitant medications included calcium and unspecified Multi Vitamin. No other vaccine in four weeks. The patient previously took erythromycin (EMYCIN) and experienced allergies, hydrocodone bitartrate/paracetamol (VICODIN) and experienced allergies. The patient experienced her back side was raw and bleeding on 12Apr2021, sour belches on 12Apr2021 08:00, vomited on 12Apr2021 08:00, having dark liquid diarrhea pouring out of her rectum on 12Apr2021 08:00, could not sleep on 12Apr2021, her entire stomach area was swollen and in extreme pain just to touch on 12Apr2021, her stomach and back side were very pain full on 13Apr2021, it was not liquid coming out of her rectum but a grey/taupe very soft stool on 14Apr2021, gassy on 14Apr2021. No treatment received. No covid tested post vaccination. Clinical course: She received the first Pfizer vaccine on 08Apr2021 evening, she thought it was easy, no problems. 12Apr2021 morning driving to work she started having sour belches, she got to work and ran to the bathroom, she vomited #6 times while having dark liquid diarrhea pouring out of her rectum, it finally stopped, 3 hours later it started again, she vomited 4 more times with more dark liquid pouring out of her rectum. Her boss sent me home. At home she was running back and forth to the bathroom the rest of the day with dark liquid diarrhea and another vomiting session throwing up #5 more times for a total of #15 Times. She could not sleep as her entire stomach area was swollen and in extreme pain just to touch and her back side was raw and bleeding. 13Apr2021 morning she vomited 3 times along with still having dark liquid diarrhea pouring out of her rectum and her stomach and back side were very pain full. 14Apr2021 she could not go to work again, she had no vomiting but continued with the on going dark liquid until 3:00 PM, she went to the bathroom and it was not liquid coming out of her rectum but a grey/taupe very soft stool. Her stomach area continued to hurt, she was still gassy. She only ate a banana, toast and Gatorade per the Dr. This was such a horrible experience. After the first shot she was praising the Pfizer Shot, now she would not. She did no really want the second shot after this experience. She was a new widow struggling, she had no one to help her, she had no phone as she had thrown up on her new phone and ruined it. This was such a terrible experience. The outcome of the events was recovering. Information on the lot/batch number has been requested.
57 2021-01-02 blood pressure increased Patient received vaccine and was fine through her 15 minute observation period. She left the clinic ... Read more
Patient received vaccine and was fine through her 15 minute observation period. She left the clinic and came back about 40 minutes later complaining of tingling in her tongue and weakness in her legs and felt like she needed to sit down. Her blood pressure was taken and it was elevated and a decision to take her to the ED was made. In the ED, she denied shortness of breath and did not have any other signs of anaphylaxis. She was given diphenhydramine 50 mg (at 11:36AM), famotidine 20 mg (@11:36AM) and prednisone 50 mg (at 11:43AM). At 12:23PM, documentation from the ED notes that tongue symptoms resolved, but patient still felt weak.
57 2021-01-03 pallor 10 minutes after injection, patient reported numbness of bottom of the feet, hands, and is experienc... Read more
10 minutes after injection, patient reported numbness of bottom of the feet, hands, and is experiencing hot/cold episodes, shaking, and pallor of lips. She also reported intermittent nausea. No changes in mental status. Patient was transferred to the ER. In the ER, she denied shortness of breath, facial swelling, hives, vomiting or diarrhea. No chest pain or voice changes. Her EKG was unremarkable. Her symptoms resolved with time, and was discharged on prednisone 20 mg PO for 4 days
57 2021-01-03 palpitations, blood pressure increased I felt like I was having palpitations, and my blood pressure shot up to 169/119.
57 2021-01-03 blood pressure increased, fast heart rate Numbs hands and feet, elevated blood pressure and tachycardia.
57 2021-01-03 palpitations Pfizer-BionTECH Covid-19 Vaccine EUA Patient reports headache beginning approximately 2 hours after ... Read more
Pfizer-BionTECH Covid-19 Vaccine EUA Patient reports headache beginning approximately 2 hours after vaccination and present continuously since vaccination date (12/21/20) to date of report (1/4/21). She notes that is has been present constantly and is worse at times but is not relieved despite use of ibuprofen, acetaminophen, naproxen, Excedrin Migraine, or eletriptan 40 mg dose. She states that this headache is similar to the headache she had with previous Covid infection in March 2020 and July 2020, which also was not relieved with any medications that she tried. Also reported heart palpitations awakening from sleep on 12/30/20. Advised to seek medical care from primary care provider. On 1/4/21 patient states that she believes headache is improving but is not resolved.
57 2021-01-04 loss of consciousness 01/04/2021 pt was feeling light headed and not "herself"' prior to 09:00PM pt fell and loss conscio... Read more
01/04/2021 pt was feeling light headed and not "herself"' prior to 09:00PM pt fell and loss consciousness. Pt was aroused by Spouse to awake after fall and checked pt blood pressure 115/63 and sugar levels 93. Pt feeling weakness afterwards, pain in back and neck from fall. Awaiting calls from PCP and Neurologist for appointments.
57 2021-01-04 pallor Dizziness, Chills and Pale
57 2021-01-04 palpitations First day I was unable to work due to severe headache. BP went crazy. I was having palpitations. I ... Read more
First day I was unable to work due to severe headache. BP went crazy. I was having palpitations. I also experienced headache, nausea, diarrhea and fever. I continue to have tingling in my face. I called employee health, and they told me to isolate. Because they were trying to rule out if it was COVID, but test was negative.
57 2021-01-04 chest discomfort, palpitations I had most of side effects described. My ears hurt, like inside, but the most that bothers me today ... Read more
I had most of side effects described. My ears hurt, like inside, but the most that bothers me today is that my heart feels like its beating and racing fast, sometimes feels like its pounding. Very uncomfortable, my chest feels.
57 2021-01-04 palpitations I had most of the side effects listed, but the one that is still bothering me til this day is that m... Read more
I had most of the side effects listed, but the one that is still bothering me til this day is that my heart feels like its racing, beating fast and sometimes feels likes its pounding, very uncomfortable.
57 2021-01-04 blood pressure increased, palpitations Patient received her vaccination then started to feel palpitations as she was waiting for 15 minutes... Read more
Patient received her vaccination then started to feel palpitations as she was waiting for 15 minutes. Then the patient felt dizzy and her BP was elevated (SBP ~135 mmHg) than her normal which is around 90/60 mmHg.
57 2021-01-04 heart rate increased Rhonchi, frothy sputum, low grade temp, elevated HR, 12/30 MD assessed 1:00PM and increased predni... Read more
Rhonchi, frothy sputum, low grade temp, elevated HR, 12/30 MD assessed 1:00PM and increased prednisone and added Cefdinir. Sent to hospital 12/30 at approximately 6:30PM with worsening symptoms
57 2021-01-04 hypotension, heart rate decreased, chest pain Shortly after vaccination developed dizziness and nausea. Within 30 minutes had low blood pressure a... Read more
Shortly after vaccination developed dizziness and nausea. Within 30 minutes had low blood pressure and pulse. Taken to ER. Also developed vomiting. Treated with epinephrine. Initially improved, then after 40 minutes heart rate dropped to low 40's and developed chest pain. Treated with 4 mg solumedrol, benadryl and more IV fluids. Slow recovery and observed over 5 hours. Went home.
57 2021-01-05 nosebleed Nosebleed
57 2021-01-05 palpitations, oxygen saturation decreased Racing heart within 15 min. and kind of whoozy. And then okay. Came back to office and developed a h... Read more
Racing heart within 15 min. and kind of whoozy. And then okay. Came back to office and developed a headache about one hour after. Took 1000 mg of Tylenol; and I was feeling okay. Just arm was sore. Not extremely sore. 8 pm at night - started shaking; knees were knocking together; severe chills; and it took a few minutes to recognize what was happening - took temp. 99.4; took another 1000mg tylenol; went to bathroom and without notice - puked; woke up an hour after going to bed with worsened chills; 10:30 pm - temp 102.4; too early to take more Tylenol and so took pharmacy's version of Nyquil. Slept through the night after Nyquil but woke up with chills continuing - temp 103. 8 at 4:30 am; and then sat at side of bed and took tylenol 1000 mg and got up to go to bathroom and couldn't walk forward and felt my arm hurt really really bad; couldn't walk forward; I leaned against the wall and bounced against the next wall and kept walking and grabbed a bedroom doorknob and got into the bathroom and fell on toilet and then crawled to couch because I couldn't walk straight. Stayed on a couch for two hours and then it was gone. Fever and chills continued that whole day on 24th. Didn't eat/had no appetite. Christmas day -no fever. Felt shaky though - like I'd been super sick. No appetite still. Felt woozy and shaky inside (felt shaky inside) and that lasted for several days. Appetite still remains poor. 02 stats were low through all of it - four liters (up two liters than normal. Contacted: a pulmonologist - Dr. and she helped with O2 questions.
57 2021-01-05 heart rate increased Rapid heart rate, shakiness, headache, rash, scratchy throat, raspy voice, dizziness, extreme weakn... Read more
Rapid heart rate, shakiness, headache, rash, scratchy throat, raspy voice, dizziness, extreme weakness
57 2021-01-06 hypertension Vomiting/threw up; Headache; muscles got rigid and tight in her neck; muscles got rigid and tight in... Read more
Vomiting/threw up; Headache; muscles got rigid and tight in her neck; muscles got rigid and tight in her neck; sick; She doesn't know if she had the flu bug or not; She also had very high blood pressure. It was through the roof/Blood pressure was high and she was concerned she would have a stroke; Muscle soreness; Arm soreness; This is a spontaneous report from a contactable healthcare professional (physical therapist). A 57-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), intramuscular on the left arm on 21Dec2020 08:15 at a single dose for COVID-19 immunisation; and sumatriptan from 25Dec2020 to an unspecified date at unknown dose and frequency (standard unknown dose/ She only gets 9 pills a month) for migraine. Medical history included ongoing migraine, obesity (She would say she was kind of obese), coeliac disease (She had Celiac disease and cannot eat gluten which was diagnosed since she was 4), chronic back pain (this was diagnosed a couple of years before she took the COVID vaccine), spinal stenosis (this was diagnosed a couple of years before she took the COVID vaccine), and pain (she took hydrocodone for pain but did not take any that day). Concomitant medication included hydrocodone for pain. Prior Vaccinations (within 4 weeks) and events following prior vaccinations were none. The patient had the vaccine on 21Dec2020, and she got sick on Christmas day. She was vomiting at 14:00 and did not know if it was a side effect or not. She did have arm soreness muscle soreness at 15:00, that evening and the next day too. She normally gets a migraine once a month. She does not normally throw up with a headache though. The vomiting started when she threw up twice on 25Dec2020, then once on morning of 26Dec2020. She also had very high blood pressure. It was through the roof. She did not know if that was related to drug for migraine or vaccine. She also had the headache at 14:00 the whole time. She believed she threw up before she took Sumatriptan. The muscles got rigid and tight in her neck and she doesn't think she took it. She threw up and then she took it. She did not have a lot or expiration. There was no ER nor physician's office required. She would have it if her car was not buried in snow. Her blood pressure was high and she was concerned she would have a stroke. It was usually around 110/70 and was always very low usually. She did not know if it was accurate, but it was 165/124 at one point and she did know her pulse was accurate. She did not provide her pulse rate. She did not know if she was throwing up because her blood pressure was high and did not know if blood pressure was high because of Sumatriptan. She only gets 9 pills a month. She did not know if high blood pressure was one of the side effects. It was not a real safe medication to take once a day. She only took it once a month and only once that day. She had never thrown up with migraines before and was just concerned. She doesn't usually take her blood pressure and doesn't know if the Sumatriptan always makes it go up or not. She doesn't know if she had the flu bug or not. The action taken in response to the events for bnt162b2 was not applicable, while for sumatriptan was unknown. Clinical outcome of sickness and influenza was unknown, for headache was recovered on 27Dec2020, while for the other events was recovering. Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the elevated BP and other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
57 2021-01-07 heart rate increased Elevated heart rate, shortness of breath, headache
57 2021-01-07 nosebleed Nose bleeds; she had allergies; This is a spontaneous report from a contactable nurse (patient). A 5... Read more
Nose bleeds; she had allergies; This is a spontaneous report from a contactable nurse (patient). A 57-year-old female patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine), Batch/lot number: EJ1685, via an unspecified route of administration on 04Jan2021 15:30 at single dose in right deltoid for COVID-19 immunization. Medical history was none. There were no concomitant medications. The patient received the Covid-19 vaccine on 04Jan2021 at 3:30pm. They monitored her for 30 minutes after she received it because she had allergies. After she got home she had a nose bleed on 04Jan2021. This morning (05Jan2021) at 5:00am she went downstairs to fix herself some food. She felt her nose running. She touched her nose with a paper towel and saw that it was bleeding. It was bleeding now. She had never had a nose bleed before. The patient had no lab tests. The outcome of the event "nose bleed" was not recovered, and of "she had allergies" was unknown.
57 2021-01-07 palpitations burning upper nose/throat; burning upper nose/throat; heart racing; headache; numbness; tingling swe... Read more
burning upper nose/throat; burning upper nose/throat; heart racing; headache; numbness; tingling swelling in left arm; tingling swelling in left arm; pain left groin left leg with muscle weakness; pain left groin left leg with muscle weakness; vomiting; tiredness; weak; This is a spontaneous report from a contactable Nurse. This 57-year-old female Nurse (patient) received dose one of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: unknown; Expiration date was not reported) on 29Dec2020 08:00 (at the age of 57-years) as single dose, Intramuscular in left arm for COVID-19 immunization. Medical history included allergies to penicillin. Prior to vaccination, the patient was diagnosed with COVID-19. The patient was not pregnant. Concomitant drugs included ASA (ASA), Famotidine (FAMOTIDINE), ergocalciferol (VIT D), ascorbic acid (VIT C), zinc (ZINC), magnesium (MAGNESIUM). The patient did not receive any other vaccines within 4 weeks prior to BNT162B2. The patient did not test for COVID-19 after vaccination. On 29Dec2020 15:00 the patient experienced 'Burning Upper Nose/Throat', 'Heart Racing', 'Headache', 'Numbness', 'Tingling Swelling in Left Arm', 'Pain Left Groin Left Leg with Muscle' 'Weakness', 'Vomiting', 'Weak', and 'Tiredness'. The patient did not received treatment as a result of the event. The outcome of event 'Burning Upper Nose/Throat' was recovered on unspecified date, 'Heart Racing' was recovered on an unspecified date, 'Headache' was recovered on unspecified date, 'Numbness' was recovered on unspecified date, 'Tingling Swelling in Left Arm' was recovered on unspecified date, 'Pain Left Groin Left Leg with Muscle' was recovered on unspecified date, 'Weakness' was recovered on unspecified date, 'Vomiting' was recovered on unspecified date, 'Weak' was recovered on unspecified date, and 'Tiredness' was recovered on unspecified date. Information on the lot/batch number has been requested.
57 2021-01-09 fast heart rate Mild General whole body Itchiness ; tachycardia; body tingling sensation Administered 50mg Benadr... Read more
Mild General whole body Itchiness ; tachycardia; body tingling sensation Administered 50mg Benadryl 4mg Dexamethasone 1-10-21 @ 11:28am monitored and resolved by 12pm
57 2021-01-10 blood pressure increased experienced symptoms of TIA; Severe aphasia; blurred vision; confusion; short term memory loss; elev... Read more
experienced symptoms of TIA; Severe aphasia; blurred vision; confusion; short term memory loss; elevated blood pressure; This is a spontaneous report from a contactable Other-HCP(Patient). A 57-year-old female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at right arm, on 22Dec2020 08:15 at single dose for COVID-19 immunization. The patient was not pregnant. Medical history included herpes simplex on lips, post menopause, elevated cholesterol w/lifestyle changes. Known allergies reported as no. Concomitant medication included varicella zoster vaccine rge (cho) (SHINGRIX) for immunization. On 04Jan2021 08:30, the patient experienced symptoms of transient ischaemic attack(TIA), severe aphasia, blurred vision, confusion, short term memory loss, elevated blood pressure. The patient admitted to (Hospital name) (still here, hospitalization days reported as 2). Symptoms resolved except very mild aphasia. The patient had very few risk factors for TIA but did have family history of cardiovascular(CV) disease at young age, low density lipoprotein(LDL) was 192. The patient did not have diabetes, HTN, or known heart disease. She did not have severe anxiety. She did not smoke or use any substances. She walked about five miles 4x a week. Weigh reported as 157. Events reported as serious due to hospitalization. The patient had no Covid prior vaccination. Covid(nasal swab) was tested post vaccination on 04Jan2021, Covid test result was Negative. The event resulted in emergency room/department or urgent care. Treatment received for the adverse event included clopidogrel bisulfate(PLAVIX), acetylsalicylic acid (ASPIRIN), statin; potassium, CT, MRI, "telemet". The outcome of the events was recovering. Information on the lot/batch number has been requested.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported symptoms of transient ischaemic attack(TIA), severe aphasia, blurred vision, confusion, short term memory loss, elevated blood pressure and the administration of BNT162B2, based on the reasonable temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, Agency, as appropriate.
57 2021-01-11 fibrin d dimer increased Patient had mild bilateral knee and hip pain 1 month ago, then she received her 1st dose of COVID va... Read more
Patient had mild bilateral knee and hip pain 1 month ago, then she received her 1st dose of COVID vaccine on 12/14/20. Her joint pain worsened then on 1/4/21 she received her 2nd dose of COIVD vaccine on 1/4/21 and then her pain increased in spread up to her shoulders. She was seen at immediate care on 1/11/21 because her joint pain had worsened throughout and her shoulder pain was making it difficult to raise her arms above the level of her shoulders. Her pain was made worse w/ movement.
57 2021-01-11 palpitations pt reported flusing sensation, face felt normal. Felt heart racing, h was 90's. some mild tingling a... Read more
pt reported flusing sensation, face felt normal. Felt heart racing, h was 90's. some mild tingling around lips, pt was calm sitting on chair
57 2021-01-12 hypertension Patient received shot at 10:18 AM, started experiencing nausea at 11:09 AM, was administered epi-pen... Read more
Patient received shot at 10:18 AM, started experiencing nausea at 11:09 AM, was administered epi-pen at 11:30 AM followed by 50mg of benadryl. Noted that patient had headache, nausea, high blood pressure, trouble breathing and went by ambulance to ER
57 2021-01-12 fast heart rate severe tremors,tachycardia
57 2021-01-13 chest discomfort This staff member, with a known history of severe allergies and history of anaphylaxis, experienced ... Read more
This staff member, with a known history of severe allergies and history of anaphylaxis, experienced tightness in chest and cough starting about 15 minutes after receiving the covid vaccine. Tightness in chest continued to worsen and she was administered her own Epi pen at 10:42AM. EMS was called and she was transported to the emergency department for further observation.
57 2021-01-14 pallor low grade fever Shakes Cold numb hands fingers blanch white blood pressure drop 70/40 severe body ac... Read more
low grade fever Shakes Cold numb hands fingers blanch white blood pressure drop 70/40 severe body aches diarrhea nausea
57 2021-01-15 palpitations COMPLAINTS OF HEART RACING; 126/80; 104HR; 96%; 22 NL OBSERVED ADDITIONAL 15 MIN. REPEATT HR 98 SYMP... Read more
COMPLAINTS OF HEART RACING; 126/80; 104HR; 96%; 22 NL OBSERVED ADDITIONAL 15 MIN. REPEATT HR 98 SYMPTOMS RESOLVED
57 2021-01-16 blood clot Constant headache began approximately 1 hr after receiving vaccine. Awoke this morning with blood cl... Read more
Constant headache began approximately 1 hr after receiving vaccine. Awoke this morning with blood clots on my tongue
57 2021-01-16 heart rate increased Patient c/o rapid heart rate about 40 minutes after vaccination. HR was 140. No other symptoms--no C... Read more
Patient c/o rapid heart rate about 40 minutes after vaccination. HR was 140. No other symptoms--no CP, no SOB, no dizziness.
57 2021-01-18 hypertension, palpitations Palpitations, high blood pressure requiring higher doses of meds. Still the BP is staying up.
57 2021-01-18 hypertension Patient experienced hypertension, dizziness, nausea, thick secretions in throat, and itchy throat. W... Read more
Patient experienced hypertension, dizziness, nausea, thick secretions in throat, and itchy throat. Was treated with a single dose of Dexamethasone 10 mg IV. Symptoms resolved and patient was sent home.
57 2021-01-19 chest pain Chills, body aches, fatigue, headache, chest pain. Went to ER on 1/19 for chest pain. Cardiac workup... Read more
Chills, body aches, fatigue, headache, chest pain. Went to ER on 1/19 for chest pain. Cardiac workup neg. Was advised that chest pain may be muscular pain from vaccine. Chest pain resolved. Continues to have fatigue, headache.
57 2021-01-19 palpitations, pallor Systemic: Nausea, Systemic: Vomiting, Systemic: palpitation, sweating, tingling on arms and hands, f... Read more
Systemic: Nausea, Systemic: Vomiting, Systemic: palpitation, sweating, tingling on arms and hands, face turned pale for few mins, hyperventilating
57 2021-01-20 chest discomfort, heart rate increased Body aches; Heaviness in her chest; Pulse is in the 90s; Now her temperature was 101.2 degrees F; So... Read more
Body aches; Heaviness in her chest; Pulse is in the 90s; Now her temperature was 101.2 degrees F; Soreness in her left arm; Chills; Not feeling too well/flu-like feeling; Not feeling too well/flu-like feeling; Slight headache / headache; This is a spontaneous report from a contactable consumer (patient). This 57-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231), via an unknown route, on 10Jan2021 at 15:00 at single dose in the left arm for COVID-19 immunisation. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EZ0140) administered in the upper left arm on 20Dec2020 (at 14:45-15:00) and developed a little headache, soreness and was tired (reported under AER 2021026236). Relevant medical history included thyroid, cholesterol and blood pressure (as reported). The patient was taking concomitant medications for underlying medical history. No other vaccine was received in four weeks. In the evening yesterday she was not feeling too well. She had a slight headache; body aches and she could get rid of the headache. She clarified that last night she felt chilly, she had the chills. By 10am this morning she did not feel well, she had a pretty bad headache and felt like she had a temperature. Her temperature earlier today was 99.4 degrees F and now her temperature was 101.2 degrees F. Her whole body feels like she was having aches, stated it is like a flu-like feeling, she had heaviness in her chest, her pulse will not go out of the 90s. She took her oxygen level and it was between 97-99%. She had also soreness in her left arm. She asked if these are common side effects, or something to be concerned about. Therapeutic measures taken as result of the events included ibuprofen (ADVIL). The outcome of the events was unknown.
57 2021-01-20 hypertension, blood pressure increased Elevated BP 200/120 known history of hypertension. Headache, Nausea and headache
57 2021-01-20 chest discomfort presented to vaccine clinic - received vaccination and while waiting - observer noted person was swa... Read more
presented to vaccine clinic - received vaccination and while waiting - observer noted person was swallowing frequently and asked if she was doing okay - she stated she felt a pressure in her chest "like my asthma" - relayed she thought she needed some Benadryl. Person was masked - observing staff asked for her to remove her mask and they noted where her mask was a pink to red outline of a fine rash. Person was subsequently taken to the ED for further evaluation and any needed treatment. ED notations: Patient is a pleasant 57 year old female with a history of asthma, eczema, obesity, LE edema presenting for vaccine reaction. Patient states she was upstairs at SCB getting her first COVID shot. She was sitting in the waiting area after receiving injection and noted to have sensation of chest tightness "similar to my asthma" within 10 minutes of receiving the vaccine. She was noted by nursing staff to also have redness to her face. Patient denied any difficulty breathing or swallowing, no raised rash/bumps to her face or body, no palpitations or fast heart rate, no swelling more than her usual baseline LE edema. She denies headache, feeling light headed, nauseous, or any symptoms of abdominal discomfort. Patient has a history of allergies to sulfa drugs and seasonal allergies, no food allergies/intolerances, or previous reactions to vaccines. Patient was determined to not be in anaphylactic shock but did have immediate symptoms after injection suggesting an allergic Type I hypersensitivity, redness and sensation in her chest improved with 50 mg of benadryl. The patient was reassured after an observational period of about 1 hour and no additional symptoms. She was notified that CDC guidelines are that even with a mild allergic reaction to the vaccine, that she should avoid getting the 2nd in series, continuing to practice other preventative measures against COVID, maintaining social distance and wearing a mask.
57 2021-01-21 fainting Patient felt faint after 10 minutes. Fainted x 3 in lobby with Involuntary movements of right uppe... Read more
Patient felt faint after 10 minutes. Fainted x 3 in lobby with Involuntary movements of right upper extremity. EMS called. Patient transferred to ER.
57 2021-01-21 chest discomfort Patient immunized approximately at 0748. Patient complained of difficulty breathing and throat irri... Read more
Patient immunized approximately at 0748. Patient complained of difficulty breathing and throat irritation while in waiting area. Monitor personnel promptly identified patient?s condition and notified the team while staying with the patient ensuring she kept talking while the provider arrived. Officer in Charge was notified during the process and was at patient?s side approximately 0756; provider followed within seconds. Decision was made for immediate transport to ED. While in route patient stopped talking, coughed and grabbed throat prompting CPT to deliver x1 dose of Epinephrine to left deltoid at 0758 with provider?s consent. Shortly after dose administration patient resumed speech but continued to complain of dry and tight throat. Patient was able to continued speaking reciting ABCs and personal information when prompted. Patient did not experience altered mental status or loss of consciousness. Arrived to Emergency Department (ED) at 0805; report given to nurse and patient was checked in promptly. ED provider plan included observation until 1100 and discharge pending follow up assessment.
57 2021-01-21 chest discomfort received the first dose of vaccine/tested positive for COVID-19; received the first dose of vaccine/... Read more
received the first dose of vaccine/tested positive for COVID-19; received the first dose of vaccine/tested positive for COVID-19; irritable all day; the sun had been bothering her eyes as she was driving, it was some eye sensitivity going on.; eyes were also hurting; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1284; expiration date not provided), via an unspecified route of administration on 04Jan2021 at SINGLE DOSE for COVID-19 immunisation. Medical history included allergies. The patient's concomitant medications were not reported. The patient reported that she received the first dose of the vaccine on 04Jan2021 and yesterday (11Jan2021) she tested positive for COVID-19. Patient would like to know if she should follow-up for the second dose of the vaccine on 25Jan2021. Patient mentioned that maybe she should follow up with the second dose. It was also reported that the patient wanted to know if the vaccine could have given her COVID-19 and tested positive. Patient further clarified it to be the Pfizer BioNTech COVID-19 Vaccine. Patient mentioned she is a caregiver and received the vaccine on last Monday (04Jan2021). On Friday (08Jan2021), the patient started to notice she was getting headaches. The headache started in the morning. Patient realized she was irritable all day and as a caregiver, this is not an attitude to have. Patient did not feel great that day. Patient also realized that the sun had been bothering her eyes as she was driving, it was some eye sensitivity going on. That night patient got home and was able to eat, but the next day on Saturday (09Jan2021), she did not have any sense of taste or smell. Patient had lost her sense of taste and smell. Patient realized this when she woke up at 6 am for coffee and could not taste or smell it. Patient was calling to find out if there was any way one could get Coronavirus only after the first shot and if she still needs to go and get her follow-up vaccine on 25Jan2021. Patient stated she forgot the name of her HCP. Patient also mentioned she has chest pressure. Patient noticed it about an hour ago, later stated it was like 11 something. It comes and goes. Patient mentioned that it was like shortness of breath. Patient would breathe in a little bit and it will bring the chest pressure back down. Patient would also walk around a bit to get the blood pumping back through. Patient also added, that due to these symptoms, she's locked off in a different room away from her husband. Patient stated they are both quarantining since her husband was exposed too and has not had the shot yet. Patient's eyes were also hurting, but that is due to the headache. Patient also stated that her eyes hurting has gone away. Patient will be getting to get a Coronovirus test done later today. When probed for the time of vaccination, patient that she was not sure. She knew she had to wait 30 minutes under observation because she had allergies. Patient initially stated that she would guess she received the vaccine thirty minutes prior to 3:55. Patient later clarified and stated it was possibly 2 something when she got it. Patient tested positive for COVID-19 on 11Jan2021 (COVID-19 virus test positive). Outcome of the event 'eyes were also hurting' was recovered, while unknown for the remaining events.
57 2021-01-24 chest discomfort Since receiving vaccine I have been having chest discomfort, but what's new is on Jan. 12, 2021, I s... Read more
Since receiving vaccine I have been having chest discomfort, but what's new is on Jan. 12, 2021, I started becoming SOB, while walking or doing simple tasks. Prior to vaccine I was fine, started symptoms after vaccine but SOB didn't happen right away, chest discomfort was there. Dds see my primary doctor on Jan. 18, prior to that I did see a doctor on Jan. 7, for chest discomfort that was bothering me. I was started on prednisone on Jan. 18, and to do neb tx at home.
57 2021-01-25 blood pressure increased Episode of Nausea,Elevated BP 207/100 1 Hour following Vaccine administration
57 2021-01-25 palpitations, fast heart rate Patient reported during her 15 minute observation to the medic that she is feeling dizzy and her hea... Read more
Patient reported during her 15 minute observation to the medic that she is feeling dizzy and her heart is racing. Patient was taken to the medic location. VS= 192/116, HR 152, O2 sat=99%
57 2021-01-25 hypertension, chest pain, fast heart rate, palpitations Tachypnea, Palpitations, HYPERtension & Angina Narrative: 12 HOURS AFTER VACCINE PT DEVELOPS TACHYCA... Read more
Tachypnea, Palpitations, HYPERtension & Angina Narrative: 12 HOURS AFTER VACCINE PT DEVELOPS TACHYCARDIA, CHEST PAIN, AND SHORTNESS OF BREATH. TREATMENT AT ER/ HOPSPITALIZATION FOR TWO DAYS.
57 2021-01-27 chest discomfort Developed shortness of breath, chest tightness and cough in addition to severe fatigue, sore throat,... Read more
Developed shortness of breath, chest tightness and cough in addition to severe fatigue, sore throat, joint/muscle pain, nausea and abdominal discomfort with diarrhea. Fatigue, fever, joint/muscle pain began the next day. Shortness of breath, chest tightness, cough and sore throat started on the second day after receiving the vaccine. Fever resolved by day 3. Shortness of breath, chest tightness, sore throat and cough resolved on the 6th day. Fatigue, muscle/joint pain resolved by day 7. Developed nasal congestion by day 5 which resolved on day 10. Treatment was rest, fluids, Tylenol, and Claritin.
57 2021-01-27 pallor generally weak; Pale; Headache; migraines; feels foggy; Hard time concentrating; pain in her shoulde... Read more
generally weak; Pale; Headache; migraines; feels foggy; Hard time concentrating; pain in her shoulder, she thought it was cause of the injection site/muscle pain from the injection; pain in shoulder immediately after getting the injection and it was really swollen; body is in pain/lot of pain all of her body; achy like she is having flu like symptoms; injection was administered higher in her left shoulder; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration on 12Jan2021 (16:00) at single dose for Covid-19 immunization. The patient received the first dose of BNT162B2 (lot number: EK9231) injection in left deltoid/shoulder on 22Dec2020 at single dose for Covid-19 immunization. The patient's medical history was reported as "none". There were no concomitant medications. It was reported that the patient received the first dose on 22Dec2020 and the second dose on 12Jan2021. After she received the second dose of the vaccine, she immediately had pain in her shoulder, she thought it was cause of the injection site (12Jan2021 16:00). She had the pain in shoulder immediately after getting the injection and she got it at 4pm, and it was really swollen now. She mentioned this injection was administered higher in her left shoulder (pending clarification) and it feels like they may have gotten the injection in more of the arm muscle and she was thinking that is why she had muscle pain from the injection. She added that it was like her body is in pain, achy like she is having flu like symptoms that started the evening she got the vaccine, like 6PM or 7PM. The next day, yesterday (13Jan2021), she had a lot of pain all of her body. She also started to have a headache yesterday at noon (13Jan2021 12:00PM). The headache started at noon on 13Jan2021 and it continued for at least 8 hours and it was constant. It started to subside over the next 12 hours. She mentioned she also suffers from migraines (pending clarification). It feels like she is having residual migraine, like she is coming off of having a migraine. It is presenting, but she is not in severe pain. It is a feeling like she is coming off her migraine medication even though she did not take her migraine medication. She went to work yesterday (13Jan2021) even though she did not feel like it. She went home a few minutes early. She let her supervisor know she was in severe pain and had a headache. She was advised to stay home today and has not gotten better. However, the headache subsided. She feels foggy, like she could not just quite wake up. It is like she is in a daze or haze. She is having a hard time functioning. She continued to reiterate she was having a hard time concentrating. Now (14Jan2021) she is generally weak and is pale. In addition, the pain has not gone away. She stated she is weak, very weak. She felt it most of the day and it is worse today. She feels like she can hardly stand. She is trying to get fluids in her and trying to make coffee, however, it is a struggle. She stated, she has not gone yet, but she will call her doctor's office next and the health nurse as well to advise them she has been having symptoms. She stated she did not have a fever last night. Her temperature during the call was normal for her, 97.3. The outcome of events vaccinations site pain, vaccination site swelling, general body pain, flu like symptoms, weak, and pale was not recovered; while the outcome of other events was unknown. Information on lot/batch has been requested.
57 2021-01-28 blood pressure increased, chest discomfort Chest pressure in middle of chest and around back. Blood pressure went high. Went to er
57 2021-01-28 oxygen saturation decreased fever 103.9F at 12 hours; Constant Coughing; severe body pain; numbness in hand (vaccine affected ar... Read more
fever 103.9F at 12 hours; Constant Coughing; severe body pain; numbness in hand (vaccine affected arm); numbness in hand (vaccine affected arm) with edema of hand; broke all the blood vessels in both eyes; O2 saturation's dropped to 86%; Headache within 1 hour; This is a spontaneous report from a contactable nurse. A 57-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), via an unspecified route of administration on arm right from 14Jan2021 12:00 to 14Jan2021 12:00 at SINGLE DOSE for covid-19 immunisation. Medical history included End-Diastolic Heart Failure, osteopenia and arthritis. Concomitant medication included losartan, furosemide (LASIX [FUROSEMIDE]), metronidazole (FLAGYL [METRONIDAZOLE]) and omeprazole. The patient took his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), from 22Dec2020, 09:00 AM to 22Dec2020, 09:00 AM on Left arm (patients age: 57 years). The patient previously took tetracycline and erythromycin and had known allergies. On 14Jan2021, the patient had headache within 1 hour, then also on 14Jan2021, at 23:00 the patient also had fever 103.9F at 12 hours, constant coughing, O2 saturation's dropped to 86%; broke all the blood vessels in both eyes; severe body pain; numbness in hand (vaccine affected arm) with edema of hand. Outcome of the events was recovering.; Sender's Comments: Based on temporal association, a possible contributory role of suspect BNT162B2 cannot be excluded for reported events broken blood vessel in eye and oxygen saturation low. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
57 2021-01-28 heart rate increased increased heart rate after that it started getting worse; a warm feeling in her chest like tingling;... Read more
increased heart rate after that it started getting worse; a warm feeling in her chest like tingling; kind of short of breath; left hand start swelling up first a little bit and then her left arm start swelling up/ her right hand start very, very mild swelling in her right hand; Chills; Fatigue; GI problems; still have some issue, did not feel good, off and on; SARS Covid antibodies test says positive; This is a spontaneous report from a contactable other nurse (patient) from a Pfizer sponsored program Pfizer First Connect. A 57-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Dec2020 at single dose (lot number: EJ1685) on Deltoid Left for covid-19 immunisation. Medical history included Paroxysmal supraventricular tachycardia. The patient's concomitant medications were not reported. The patient experienced a warm feeling in her chest like tingling; kind of short of breath, it went away like she said it was just breath it was like for couple of minutes and then it went away and then she was just fine till it's been long here honestly about 3 or 4 days later; got shot in her right arm but left hand start swelling up first a little bit and then her left arm start swelling up and it's just and then that's the base and then her right hand start very, very mild swelling in her right hand. The hospital think there as some clot or something weird but she did not and then that started going down after that it just started going down and went away and never had swelling since then but this was going to long but this was something weird happened to her. She got chills, She got fatigue. She had increased heart rate after that it started getting worse. She had Paroxysmal supraventricular tachycardia, she had that always but it's been control. She walked 5 miles daily a day, she was in shape, she had lot since then, so it's been under control, she never had problem with it until after she got the shot, her heart rate was she had to add medication, she never have to add. She took metoprolol (Treatment) so she added that and she added more and that's thing get it under control and then she take herself back off because she felt like it was under control but she had GI problems since, now she was getting better now, still have some issue, did not feel good, off and on. The patient underwent lab tests and procedures which included blood test: good on 04Jan2021 (blood work to see if something was going on to her heart, because she had short breath, and everything was good), weight: 166 or 164, SARS Covid antibodies test IgM on 04Jan2021: positive. Treatment: Nurse stated, "No, not now, I had a heart-rate monitor, it's what for see what is my heart rate, to locate and see what's going on." Outcome of left hand start swelling up first a little bit and then her left arm start swelling up/ her right hand start very, very mild swelling in her right hand was recovered.; Sender's Comments: There is not a reasonable possibility that event heart rate increased is related to BNT162B2. The event is most likely due to underlying paroxysmal supraventricular tachycardia. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
57 2021-01-31 chest discomfort Started with temp on Monday night 103.8, headache, chills, dizziness, sweats, fever, flutter in my c... Read more
Started with temp on Monday night 103.8, headache, chills, dizziness, sweats, fever, flutter in my chest off and on. Got worse Tuesday with the same symptoms. Took Ibuprofen to help with fever. Wednesday went to ER with flutter in chest. Was Frequent PVC?s. Had fever, headache, and dizzy until Sunday. So far today Monday 2-1-21 no fever just dizzy and flutter in chest off and on.
57 2021-02-01 hypertension Subconjunctival hemorrhage of right eye due to new onset hypertension; Subconjunctival hemorrhage of... Read more
Subconjunctival hemorrhage of right eye due to new onset hypertension; Subconjunctival hemorrhage of right eye due to new onset hypertension; headache; This is a spontaneous report from a contactable Nurse. This nurse reported for self that the 57-year-old female patient received second dose of bnt162b2 (BNT162B2, COVID 19, Pfizer, lot number: EK9231, exp date and batch were not reported) via unknown route of administration on 13Jan2021 10:00 AM on Left arm at a single dose for covid-19 immunization. She is not pregnant. Medical history included known allergies: Sulfa (Sulfonamide Antibiotics), Hypothyroidism, Hx Atrial Flutter ablation resolved, Hx Hysterectomy. Concomitant medications included Estradiol, Propranolol, levothyroxine/liothyronine (NP THYROID), Aspirin [acetylsalicylic acid], MVI. The patient previously took first dose of bnt162b2 (BNT162B2, COVID 19 Covid-19 mRNA vaccine/Pfizer, lot number: EK5730, exp date and batch were not reported) via unknown route of administration on 23Dec2020 08:00 AM on Right arm at a single dose for covid-19 immunization. Facility type vaccine was Hospital. No other vaccine in fourweeks. The patient experienced Subconjuctival hemorrhage of right eye due to new onset hypertension, headache from 13Jan2021 06:00 PM. Ae resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Treatment received and started on Lisinopril. No covid prior vaccination. Covid tested post vaccination. The outcome of the event was recovering. Covid test post vaccination included covid test type post vaccination was Nasal Swab, covid test name post vaccination was Covid rapid test on 15Jan2021 with covid test result: Negative. on 17Jan2021, covid test type post vaccination was Nasal Swab, covid test name post vaccination was Covid with covid test result: Negative.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the events conjunctival haemorrhage and hypertension cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
57 2021-02-04 loss of consciousness I woke up in the middle of the night with a headache and body aches. I got up to take ibuprofen and ... Read more
I woke up in the middle of the night with a headache and body aches. I got up to take ibuprofen and when I was in my bathroom, I collapsed. I do not remember actually falling but I heard the thud when I hit the floor. I tried to get up and had absolutely no strength in any part of body. My husband came to help me up but I could not even lift up my head. He was finally able to help me up and I took a few steps and collapsed/fainted again. This has never happened to me in my life.
57 2021-02-04 chest discomfort, palpitations Patient developed chest tightness, palpitations, and SOB approximately 8 min after vaccination. At 1... Read more
Patient developed chest tightness, palpitations, and SOB approximately 8 min after vaccination. At 12min post-vaccination patient developed throat tightness/itching. 0.3mL epinephrine auto-injector was administered at the vaccination site and the patient was transported to the emergency department for further treatment. Patient reported epinephrine made her symptoms worse. Emergency Department provider diagnoses symptoms as anxiety and gave a dose of lorazepam which improved the patient's condition. The patient was discharged from the ED after being monitored for 4 hours with improvement in symptoms. No further treatment was given.
57 2021-02-05 palpitations Heart began racing suddenly, to about 120-140 bpm. No shortness of breath, chest pain, sweating or a... Read more
Heart began racing suddenly, to about 120-140 bpm. No shortness of breath, chest pain, sweating or any other symptoms. Lasted approximately 2-3 minutes after which heart rate returned to normal (72-76 bpm).
57 2021-02-07 chest pain At midnight the same day after the vaccine she awakened feeling cold, sweating, and had a temp of 10... Read more
At midnight the same day after the vaccine she awakened feeling cold, sweating, and had a temp of 101.6 F. Pt had fever for 24 hours. She took Tylenol at that time. Her face was also red after the second vaccine and has remained red around the lower half of her face. Her face tingles at times. She feels like bugs are walking on her face and body at times, get itchy at times, gets hot, then gets cold. Pt felt a zap like electricity in her bosom for on 1 day in her left breast/ chest fleetingly. She feels it, zaps, sometimes in other places in her body since then rarely, not daily.
57 2021-02-07 chest discomfort Pt reports chest tightness, tongue numbness, normal EKG. Pt recovered
57 2021-02-07 chest pain SOB with chest pain, headache
57 2021-02-07 chest discomfort Ten minutes after the vaccine was administered the patient started with a persistent nonproductive c... Read more
Ten minutes after the vaccine was administered the patient started with a persistent nonproductive cough, hoarseness, chest tightness, shortness of breath. Vital Signs BP 128/77: P=96: R=19: O2 sat=100% Oxygen was administered by nasal cannula, Solumedrol 125mg IV and nebulizer therapy with Atrovent 0.2 x 1. Was kept under observation and after one hour the patient had recovered. Per the patient.
57 2021-02-08 heart rate increased Immediate tingling of LA/face/leg; BP 152/82 (pulse 94), BP 146/77 (pulse 102). Called 911.
57 2021-02-09 fast heart rate Tachycardia; dizziness; flushed feeling; sweating to hands and back of neck; This is a spontaneous r... Read more
Tachycardia; dizziness; flushed feeling; sweating to hands and back of neck; This is a spontaneous report from a contactable nurse reporting for herself. A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot:Ek4176), via an unspecified route of administration on the left arm on 12Jan2021 17:30 at a SINGLE DOSE for covid-19 immunisation. Medical history included hypertension, melanoma in situ, diverticulosis, allergies to sulfa, betadine and reacted to depo-medrol injection. Concomitant medication included lisinopril (LISINOPRIL), estradiol (ESTRADIOL), ibuprofen (MOTRIN) and cyanocobalamin (B12). The patient experienced tachycardia, dizziness, flushed feeling and sweating to hands and back of neck on 12Jan2021 17:30. Therapeutic measures (Benadryl 25mg) were taken as a result of the events. The outcome of the events was recovered on an unspecified date in Jan2021.
57 2021-02-09 chest pain her upper chest, the medial aspect of her left arm and down her upper arm initially pain; her upper ... Read more
her upper chest, the medial aspect of her left arm and down her upper arm initially pain; her upper chest, the medial aspect of her left arm and down her upper arm initially pain/fingers ached; down her upper arm initially pain; About 15 minutes later her wrist and fingers ached/joint pain; a gradual increase of body aches; nausea; feeling 'hot'; Big time tired, fatigue the patient would go to bed early; This is a spontaneous report from a contactable Nurse (patient). A 57-year-old female patient received first dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine), via an unspecified route of administration at Arm Left on 25Jan2021 14:15 at the 57 years old at single dose for COVID-19 immunization. The medical history included FAP (Familial adenomatous polyposis), hernia repair, ankylosing spondylitis, bipolar disorder II, chronic depression, PTSD(Post-traumatic stress disorder), anxiety, GERD, Penicillin allergy, Adhesive tape allergy, Antiemetics allergy. The concomitant medications were amlodipine, ASA, HCTZ, lamotrigine (LAMICTAL), losartan, naproxen. The patient previously took Ciprofloxacin and experienced allergy, Ativan and experienced allergy. Right after the patient received the shot on 25Jan2021 14:30, her left side of her upper chest, the medial aspect of her left arm and down her upper arm initially pain. About 15 minutes later her wrist and fingers ached. From then on 25Jan2021 14:30, a gradual increase of body aches and joint pain, some nausea feeling 'hot' but not 'hot flashes' no sweats, Big time tired, fatigue the patient would go to bed early. She was keeping very hydrated. There was no other vaccine in four weeks. There was no treatment for the adverse events. There was no covid prior vaccination. There was no covid tested post vaccination. The outcome of the events was recovering. Information about lot/batch number has been requested.
57 2021-02-10 hypertension Blood pressure was also a little elevated on 22Jan2021, 196/106/ 179/101 on 27Jan2021; severe left ... Read more
Blood pressure was also a little elevated on 22Jan2021, 196/106/ 179/101 on 27Jan2021; severe left facial swelling; facial abscess; This is a spontaneous report from a contactable health care professional (nurse practitioner). A 57-Year-old female patient received her 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on an unknown date in Jan2021 for Covid-19 immunization. Medical history included hypertension diagnosed for years as of 27Jan2021, and dental cleaning (also reported unsure if it was after or before vaccine). Concomitant drug was reported as "none". She not sure of the exact date of administration, stated patient came in to the office to be seen on Friday morning, 22Jan2021. Patient told caller at that time that she had the vaccine last week as of 27Jan2021, was seen for severe left facial swelling, onset of symptom was on Wednesday 20Jan2021. She was treated for facial abscess with Clindamycin 300mg 4 x a day for 10 days, she took first dose of treatment on Friday 22Jan2021. She followed up with doctor on 27Jan2021 and was improved, about 75%better. Her Blood pressure was also a little elevated on 22Jan2021 visit, it was 196/106 and on 27Jan2021 it was 179/101, did not know if this related to vaccine or symptoms. Patient reported that she went to dentist and had cleaning, unknown exact date of cleaning, unsure if it was after or before vaccine. She stated that doctor thought the symptoms could be due to dental cleaning not the vaccine. Patient went to ENT on Monday 25Jan2021 and they cleared her of anything ENT related from her neck up; scoped her and looked at her sinuses, and everything was fine. The ENT doctors told the patient that it appeared to be a reaction to the vaccine and advised her not to get the second dose. The reporter inquired whether patient should get the second dose. No Investigation Assessment was performed. The event severe left facial swelling was reported as serious with seriousness criteria of other medically important condition. Outcome of the event severe left facial swelling and facial abscess was resolving. Outcome of the other event was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the outcome of treatment, the reported events severe left facial swelling, facial abscess, and elevated BP are likely intercurrent medical conditions and are unrelated to suspect drug BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
57 2021-02-12 blood clot Fever, Diarrhea, 1/20/21 SYMPTOMS BEGAN. ADMITTED TO HOSPITAL & CONTACTED EOH 1/27/21 WITH FEVER, CH... Read more
Fever, Diarrhea, 1/20/21 SYMPTOMS BEGAN. ADMITTED TO HOSPITAL & CONTACTED EOH 1/27/21 WITH FEVER, CHILLS,SOB, COUGH., DIARRHEA, BLOOD CLOTS, FLUID AROUND HEART. Narrative: Other Relevant History:
57 2021-02-14 chest pain Nerve Damage Symptoms; its achy all on the left side; shoulder pain; Being lower back pain; the pain... Read more
Nerve Damage Symptoms; its achy all on the left side; shoulder pain; Being lower back pain; the pain in shoulder went to the arms, back across to the front of the chest; dull aching pain; she didn't sleep; groggy; The pain in shoulder went to the arms, back across to the front of the chest; This is a spontaneous report from a contactable consumer (patient). A 57-year old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE lot number EK9231) (at the age of 57-years-old), via an unspecified route of administration on 20Jan2021 as a single dose for covid-19 immunization. The facility where COVID-19 vaccine was administered was at a hospital and anatomically located on the left arm. The patient medical history included acid reflux She has been good for last 2 months. She was on Pepcid but not anymore; uterine polyp removal in 2019 (reported as 2 years ago) polyps removed from uterine wall, it was done outpatient but they still put her to sleep, but it had took her 2 weeks to get over the reaction of being put to sleep, it was the anesthesia, it wasn't pain, but she was very tired and groggy after. She does not know the name of the Anesthesia or have any Lot or Expiry; receives flu shot every year with no issue. The patient was not taking any concomitant medications. She has had No positive antibody or Covid test prior to the vaccine. She took the first shot last Wednesday 20Jan2021, she had a weird, not the usual reactions like she had read about. She even went to the Nurse Practitioner yesterday because of it. She was told she has nerve damage from the shot and a high immune response to the shot, which is a good thing, but her question is does she take the second shot. The nerve damage started at 10 o clock that night causing shoulder pain, back pain, being lower back pain, because of it she didn't sleep, only 3 hour Thursday night. She's a teacher and even had to miss school on Friday. It is just a constant dull aching pain. She was groggy. Some symptoms were typical. She never ran a fever, the pain in shoulder went to the arms, back across to the front of the chest, she can follow with the hand here, its achy all on the left side. She went to the Nurse Practitioner and she said it sounds like nerve damage. The NP did not do any test, she really just left the office hoping that it would resolve on its own. Caller states that this is not going away. She actually read to not even take Tylenol or Advil 2 days prior as it can lessen the effectiveness of the vaccine. That's why she didn't take Tylenol till Friday Afternoon on 22Jan2021. She toughed it out for 2 days. The doctor told her she can take Advil right now. The clinical outcome of the event: Low Back pain recovered; event Nerve damage was recovering; events achy all on the left side, Dull aching pain, shoulder pain, chest pain, Pain in arm, she didn't sleep, groggy unknown. She is scheduled for the second dose on 10Feb2021.
57 2021-02-21 hypotension, heart rate increased Rapid heart rate Burning through body Cold sweat Felt low blood pressure
57 2021-02-22 pallor Approximately 10 minutes after vaccination (during post vaccination observation), patient reported f... Read more
Approximately 10 minutes after vaccination (during post vaccination observation), patient reported feeling ?off? and that her throat hurt. I was contacted via radio to aid with assessment. Upon my arrival, patient reported that that she was experiencing slight difficulty swallowing, was feeling ?off? and felt ?like her head was in a fog?. Assessment of vitals revealed an intial vital signs of respiration rate of 18 breaths per minute, pulse of 74 beats per minute, 97% oxygen saturation levels. Blood pressure was obtained prior to arrival and was reported as 121/74. Lungs were clear to auscultation bilaterally. Clear S1 and S2 were present upon cardiac auscultation with no mumurs or gallops noted. Patient appeared slightly pale with a slightly hoarse voice. Patient did not have noticeable pharyngeal edema upon examination. Patiney had no increased work of breathing and was not using accessory Muscles for breathing. Patient was given a swallow test using bottled water and then solid food and demonstrated intact ability to swallow with no regurgitation, choking or drooling noted. Continuous oxygen saturation monitoring revealed 02 that never fell below 96%. Continuous pulse monitoring revealed a pulse that was between 74-79. Given the stability the vital signs, demonstrated ability to swallow and inappropriately labeled IM medication in emergency kit (ie three loose syringes were not drawn up by myself. Medications were labeled by hand with no expiration date, route or dose), I elected to give the patient 25 mg of oral diphenhydramine. Patient declined to seek emergency medical attention several times. Patient?s daughter was then called so that the patient could be driven home. Patient was advised to seek emergency medical attention if her symptoms worsened, she developed increased difficultly breathing or otherwise felt unwell. Advised to follow up with PCP within next 24 hours.
57 2021-02-23 palpitations, lightheadedness I felt like I was going to pass out; suddenly all over my body under my skin was burning everywhere;... Read more
I felt like I was going to pass out; suddenly all over my body under my skin was burning everywhere; my heart was pounding so fast; dizzy; seeing blurry; tongue was stinging; eye lids were burning; I didn't feel right the whole rest of the night.; This is a spontaneous report from a contactable consumer. A 57-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231/212080597001), the first dose, via an unspecified route of administration on 31Dec2020 18:30 at single dose for covid-19 immunisation. Medical history included High Cholest. Type 2 Diabetes, High Blood Pressure, Fatty Liver, Overweight, and allergies to medications: Penicillin. Concomitant medication included levothyroxine sodium (UNITHROID), olmesartan medoxomil (BENICAR), rosuvastatin, empagliflozin, linagliptin (GLYXAMBI), escitalopram oxalate (LEXAPRO). After injections (on 31Dec2020) when to sit down, suddenly all over my body under my skin was burning everywhere and my heart was pounding so fast I thought it was going to come out of my chest. I got dizzy and was seeing blurry. At the end my tongue was stinging and my eye lids were burning. I felt like I was going to pass out. Then finally subsided but I didn't feel right the whole rest of the night.Therapeutic measures were taken as a result of all events. The outcome of events was recovered.Prior to vaccination, the patient did not diagnosed with COVID-19.Since the vaccination, the patient has not been tested for COVID-19. The case considered non-serious (Seriousness criteria-Results in death: No;Life threatening: No;Caused/prolonged hospitalization: No;Disabling/Incapacitating: No;Congenital anomaly/birth defect:No). Follow-up attempts are completed. No further information is expected.
57 2021-02-23 chest pain Sore arm; Pain in chest to her left upper sternal border area (under collar bone); Pain in the neck,... Read more
Sore arm; Pain in chest to her left upper sternal border area (under collar bone); Pain in the neck, its an aching pain, a nuisance type of pain; This is a spontaneous report from a contactable healthcare professional (patient). A 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK9231; Expiration date was not reported), intramuscularly on the left deltoid on 28Dec2020 (07:15) at a single dose for COVID-19 immunization at the hospital. The had no relevant medical history and concomitant medications. On an unspecified date, after the first dose of vaccination, the patient had sore arm; pain in chest to her upper sternal border area (under the collar bone); and pain in the neck (further described as "an aching pain, a nuisance type of pain"). The patient had chest x-ray on 25Jan2021 (results were not provided). The patient had received paracetamol (TYLENOL), naproxen sodium (ALEVE) and ibuprofen as treatment for the reported events. The outcome of the events was not recovered for 'pain in chest to her upper sternal border area (under the collar bone)'; and was unknown for 'sore arm' and 'pain in the neck'. The patient had received the second dose of vaccination on 14Jan2021. The reporter believed that it was "highly coincidental" (pertaining to causality) considering the events happened with both vaccine doses. No further information was provided or obtained.
57 2021-02-23 heart attack The roof of my mouth shedded (was raw) and bleed for a few days; The roof of my mouth shedded (was r... Read more
The roof of my mouth shedded (was raw) and bleed for a few days; The roof of my mouth shedded (was raw) and bleed for a few days; I felt like I was having a heart attack; This is a spontaneous report from a contactable other healthcare professional (patient). A 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number and expiration date were unknown), intramuscularly on 29Jan2021 at 09:30 AM at a single dose for COVID-19 immunisation. The patient's medical history included asthma and known allergies to medication. Concomitant medications included paracetamol (TYLENOL) and metoprolol, which were reported as medications in two weeks. It was reported that other vaccines in four weeks were prescribed. On 31Jan2021 at 09:00 AM, the patient experienced the roof of her mouth shedded (was raw) and bled for a few days. A few days later (2021), she felt like she was having a heart attack. There was no treatment for the events. The patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. The outcome of the events was recovered on 2021. Information about lot/batch number has been requested.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event myocardial infarction cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
57 2021-02-23 chest pain arm is sore; pain in her chest as she had before/pain in chest to her left upper sternal border area... Read more
arm is sore; pain in her chest as she had before/pain in chest to her left upper sternal border area (under collar bone); fatigued; chills; fever; body aches, it was more like body cramping; body aches, it was more like body cramping; This is a spontaneous report from a contactable nurse (patient). A 57-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231 and expiry date: unknown), intramuscular on the left deltoid, on 14Jan2021 07:15 at a single dose for COVID-19 immunization. The first dose was received on 28Dec2020 (lot number: EK9231), intramuscular on the left deltoid and patient experienced sore arm, and left upper (under collar bone) pain in her chest. The patient medical history was not reported. There were no concomitant medications. She received the vaccine around 7:15 in the morning and by midnight on 15Jan2021 (she works nights), she started to feel the pain. By that point, she was like "ooh, my arm is sore". She also started to have the same pain in her chest as she had before (pain in chest to her left upper sternal border area (under collar bone). Her doctor ordered a chest x-ray on 25Jan2021. Patient stated it was not cardiac. It's just there. The pain was annoying and she can feel it when she moves or when she goes to get up, it's an ache. Its a pain in the neck. On Friday, 15Jan2021, she was real fatigued, had chills, a little bit of a fever, and body aches. She clarified it was more like body cramping and her body hurt so bad. She over that by Sunday.All of her symptoms resolved by Sunday 17Jan2021, except for the pain she was experiencing in her chest which was still ongoing and persisting. She had taken Tylenol, Aleve, and Ibuprofen, but it doesn't resolve the pain at all. Outcome of the event of sore arm was unknown, for pain in chest was not recovered while for the remaining events was recovered on 17Jan2021.
57 2021-02-26 hypotension, pallor Immediately after being vaccinated the patient requested to lie on the floor because she felt dizzy.... Read more
Immediately after being vaccinated the patient requested to lie on the floor because she felt dizzy. RN place patient in a reclining position and requested evaluation of patient by NP.Patient was pale, and diaphoretic.Patient denied chest pain, SOB, N/V, negative rash, negative facial swelling,Pt was Hypotensive.EMS was activated .Repeat V/S 3 minutes later were WNL pt remained A&O throughout encounter.Pt stated " this has happened before". Patient was transported to Hospital Via EMS
57 2021-03-03 heart rate increased, blood pressure increased Swollen neck area now about 5 cm diameter. Has increased over time. Back of neck - starts at base of... Read more
Swollen neck area now about 5 cm diameter. Has increased over time. Back of neck - starts at base of skull just under hairline. Tender to touch. Limits mobility range (hard to turn head, tilt forward and back). Started with small 1m area Sunday night on 2/28 and has continued to grow. No fever. No pain anywhere else on body
57 2021-03-04 blood pressure decreased, loss of consciousness The patient went unconscious and was having slight involuntary muscle jerks while on dialysis. The p... Read more
The patient went unconscious and was having slight involuntary muscle jerks while on dialysis. The patients blood pressure dropped to 63 systolic. Shortly after a 500ml saline bolus, patient stabilized. Patient left on ambulance by request. This is not believed to be an allergic reaction to the vaccine, but due to the timing, is being reported as an adverse event for review.
57 2021-03-07 haemoglobin decreased Vaccine received from off site facility. Unknown site or lot number. Patient started to experience... Read more
Vaccine received from off site facility. Unknown site or lot number. Patient started to experience joint pain the evening of vaccine. Joint pain leading to joint swelling in both knees, wrist and elbow. No fever. Lower leg swelling. Complaint of extreme pain.
57 2021-03-08 chest pain Anaphylaxis - rash and hives from head to toes, severe itching, difficulty breathing, and chest pain... Read more
Anaphylaxis - rash and hives from head to toes, severe itching, difficulty breathing, and chest pain. Oxygen Saturation was at 87 when I arrived. Treated with dexamethasone sod phosphate PF last given at 5:45 PM, diphenhydrAMINE (Benadryl) last given at 5:45 PM, EPINEPHrine last given at 5:45 PM, famotine last given at 6:08 PM, GI cocktail oral suspension last given at 6:44 PM, hydrocortisone last given at 8:18 PM, LORazepam last given at 5:48 and 6:45 PM, ondansetron last given at 5:48.
57 2021-03-11 palpitations, heart rate increased First dose I felt go to my heart 20 min after getting it. Second dose day after receiving had very r... Read more
First dose I felt go to my heart 20 min after getting it. Second dose day after receiving had very rapid heart rate and hard pounding
57 2021-03-16 heart rate increased, blood pressure decreased Levels of TSH, among other indicators that pointed towards onset of hyperthyroidism. My doctor told ... Read more
Levels of TSH, among other indicators that pointed towards onset of hyperthyroidism. My doctor told me that this was acute thyroiditis. My heart rate was very high (122 bpm) when I visited my doctor's office and it was 130 bpm when I was triaged in the Emergency Room. Upon my doctor's advice, I went to the ER in the afternoon of 03/12/2021 where I was further tested. I was given medications to counteract inflammation, nausea and headache. In addition, I was given medication (beta blocker) to lower my heart rate. When my blood pressure was taken after a couple of hours, the readings revealed that my pressure had also started to fall. I spent overnight in the telemetry unit of the ER - I was given 2 liters of IV fluids to stabilize my vitals. The following day (03/13/2021), I met with endocrinologists who told me to what extent my thyroids were affected and what further medications to take. I had told them and other ER doctors as to what precipitated all of this. I was given anti inflammatory medication and a beta blocker that day before I was discharged in the evening. I have no history of thyroid issues or heart issues. I do not suffer from any chronic illness. I was not sick before I took the second dose of the vaccine. I started to feel ill within 5 hours of taking the vaccine shot, and the symptoms worsened over nearly the following two weeks. Now, following medical intervention, I am continuing treatment with various medications. I don't feel well yet, and I understand that the process towards recovery is going to be slow and unpredictable. I wanted to report this, since I feel that scientists and researchers should have this knowledge that thyroiditis can happen as an adverse reaction to the COVID-19 vaccine (Pfizer/BioNTech).
57 2021-03-21 hypertension High BP variation and sodium level dropped
57 2021-03-23 chest discomfort throat and chest tightening, severe headache, dizzy
57 2021-03-27 chest pain left scars to her left breast still, that look like white crust on them/scars on her left breast; le... Read more
left scars to her left breast still, that look like white crust on them/scars on her left breast; left scars to her left breast still, that look like white crust on them; bumps on her chest that won't heal up; skin blistered up like shingles centered to her left breast in the middle; spots were white and puffy, and some left a bump around; pain in her left chest still from the middle to her arm down to her elbow; pain goes from her front to the back of her shoulder blade and around; nerve pain; every once in a while she loses her grip with her left hand though not too much and she can grab again what was slipping; bumps on the left side of the chest/still has lumps, some were white and some have busted open; broke out with what thought as a nurse was shingles; arm swelling after the injection; pain/stabbing pain/nagging pain; pain in her arm that went to her chest area/Under her arm and going down she feels a pinching sensation; Her left arm was swollen at the injection site; This is a spontaneous report from a contactable nurse (patient) from the medical information team. A 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration, administered in the left arm on 22Jan2021 at a single dose (at the age of 57-years-old) for COVID-19 immunisation. The patient was given the vaccine in a pharmacy/drug store. Medical history included diabetes and hypertension. There were no concomitant medications. The patient experienced arm swelling after the injection, then a little later on in the day experienced pain. The next day or so, she got bumps on the left side of the chest. Thought it was shingles and was given medicine for shingles but ended up not being shingles. She still has lumps, some were white and some have busted open, approximately 4. She still had arm pain and back. Arm was still swollen. Went back to doctor on 10Mar2021 and gave another round of antibiotics. Still has a stabbing pain from the from to the back. "1 cm to 1.5 cm." She had scheduled for a breast screening done. She was still having pain almost 2 months later. The patient provided further information: the patient only got her first dose of the vaccine. Her side effects began that day then gradually got worse. Her left arm was swollen at the injection site since 22Jan2021 and was still swollen at the time of the report. A couple of hours afterwards as the day went on, she had pain in her arm that went to her chest area. The next day (23Jan2021), she broke out with what thought as a nurse was shingles, but was just in one little spot, so she went to the doctor and gave her medicine, antibiotics, and then she took those for 7 days three times a day. The first antibiotic she was on when they thought it was shingles was azithromycin (ZITHROMAX). After then, the pain would not go away and has left scars to her left breast still, that look like white crust on them. She has pain in her left chest still from the middle to her arm down to her elbow. She has two different types of pain, and when she went back to the doctor a day before (10Mar2021), she was given more antibiotics. The pain goes from her front to the back of her shoulder blade and around and was a stabbing pain. Under her arm and going down she feels a pinching sensation that won't go away, and was all the time. They wouldn't give her the second vaccine dose while she was on antibiotics that appointment reached its due. The pharmacist came on 05Mar2021 which would be her third appointment to get the vaccine and told the pharmacist her reaction to the COVID shot. The pharmacist asked to look at her injury and then wouldn't give the vaccine to her. Her doctor gave her some pain medication that would be good for nerves. She can't take gabapentin and doesn't like to take pain pills for the nerve pain, so she does paracetamol (TYLENOL) and ibuprofen every other time to relieve the pain. She says she has been taking paracetamol 500mg extra strength twice a day by mouth, and ibuprofen 400mg twice a day by mouth. She was wondering if there was any information on if her pain would get better since she doesn't want to stay the same or for it to get worse that what it is. It was a nagging pain that she can't seem to get rid of and every once in a while she loses her grip with her left hand though not too much and she can grab again what was slipping. The gabapentin for her nerve pain gave her side effects, she was taking 300 mg one pill four times a day. She took about three days worth and starting in Feb2021 she thought. The new antibiotic given on 10Mar2021 that she takes for the bumps on her chest that won't heal up was cefdinir 300 mg. She says after her vaccine her skin blistered up like shingles centered to her left breast in the middle, which she thought originally would spread all around but it didn't, it stopped right there. She says that the spots were white and puffy, and some left a bump around in them where they healed up. She says her doctor wanted her to get a mammogram done, which is scheduled for the first Monday in Apr2021. No labs were done, "they just looked at them". The patient felt bumps on the left side of the chest was medically significant because the scars and bumps have been there a while and several were not healing well. The patient has not recovered from the events. Information on the lot/batch number has been requested.
57 2021-03-29 heart rate increased, atrial fibrillation Fast heart rate/ atial Fib went to the emergency on 3/8/2021 at 8pm
57 2021-03-30 pulmonary embolism Diagnosed in ER with 4 subsegmental pulmonary embolisms on 18Mar2021 shown with CT Scan with contras... Read more
Diagnosed in ER with 4 subsegmental pulmonary embolisms on 18Mar2021 shown with CT Scan with contrast; Shortness of Breath; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: En5318), via an unspecified route of administration, administered in left arm on 04Feb2021 10:00 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. The patient was not pregnant at the time of report. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: El3249) administered on the left arm on 14Jan2021 10:00 AM for COVID-19 immunization. The patient was diagnosed in Emergency room (ER) with 4 subsegmental pulmonary embolisms on 18mar2021 16:00 shown with CT scan with contrast and experienced shortness of breath on 18Mar2021 16:00. Prior to vaccination, the patient was not diagnosed with COVID. Patient was tested COVID post vaccination. The patient underwent lab tests and procedures which included CT scan with contrast: 4 subsegmental pulmonary embolisms on 18Mar2021, and nasal swab: negative on 14Jan2021. Therapeutic measures were taken as a result of the events and included treatment with apixaban (ELIQUIS). Facility type vaccine was Nursing Home. The event resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent case, life threatening illness (immediate risk of death from the event). The outcome of the events were recovering.
57 2021-04-06 hypertension Around 48 hours after vaccination, blood pressure was very high, 173/105; This is a spontaneous repo... Read more
Around 48 hours after vaccination, blood pressure was very high, 173/105; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EP6955), via an unspecified route of administration administered in left arm at a pharmacy or drug store facility on 19Mar2021 12:30 as SINGLE DOSE for COVID-19 immunisation. The patient had no other vaccine in four weeks. The patient was not pregnant at the time of vaccination. Medical history included hypertension which was controlled and never had it been over 155/98. The patient had no known allergies. The patient had no COVID prior vaccination and was not COVID tested post vaccination. Concomitant medications included levothyroxine sodium (SYNTHROID), losartan, and sertraline. On 21Mar2021 at 12:15 PM, around 48 hours after vaccination, blood pressure was very high, 173/105. Contacted doctor a took 2 additional dosage of losartan 25 mg. Two hours after 3rd pill BP was 192/114. The patient had not consumed salt or alcohol and did not have any preoccupations or anxiety. The event caused hospitalization on an unspecified date. The event resulted in emergency room and physician office visits. Therapeutic measures were taken as a result of the event includes had electrocardiogram (EKG) and waited more time until losartan lower. On an unspecified date, the patient recovered from the event.
57 2021-04-08 loss of consciousness PATIENT REPORTS BEING IN A PARKING LOT 2.5 HOURS AFTER RECEIVING VACCINE AND BLACKING OUT AND WHEN S... Read more
PATIENT REPORTS BEING IN A PARKING LOT 2.5 HOURS AFTER RECEIVING VACCINE AND BLACKING OUT AND WHEN SHE CAME TO, SHE WAS IN THE HOSPITAL AFTER HAVING TO HAVE CHEST COMPRESSIONS FOR 30 MINUTES TO BRING HER BACK. AFTER HOSPITAL EVALUATION, THE ONLY THING THE HOSPITAL COULD ATTRIBUTE HER EPISODE TO WAS THE VACCINE AS NOTHING ELSE SHOWED ON LAB WORK AND EXAMINATION AND PATIENT DID NOTHING ELSE DIFFERENTLY.
57 2021-04-12 blood pressure increased Blood pressure was elevated; Started with sweating then light headed nausea and dizzy. 30 minutes a... Read more
Blood pressure was elevated; Started with sweating then light headed nausea and dizzy. 30 minutes after injection broke out with hives on neck and chest rash on face. Blood pressure was elevated.; Started with sweating then light headed nausea and dizzy. 30 minutes after injection broke out with hives on neck and chest rash on face. Blood pressure was elevated.; Started with sweating then light headed nausea and dizzy. 30 minutes after injection broke out with hives on neck and chest rash on face. Blood pressure was elevated.; Started with sweating then light headed nausea and dizzy. 30 minutes after injection broke out with hives on neck and chest rash on face. Blood pressure was elevated.; Started with sweating then light headed nausea and dizzy. 30 minutes after injection broke out with hives on neck and chest rash on face. Blood pressure was elevated.; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 57-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: Ep7533) via an unspecified route of administration at arm left on 30Mar2021 10:00 as single dose for COVID-19 immunization. The patient has other medical history and concomitant medications was not reported. The patient was not diagnosed with COVID-19 prior to vaccination. Patient had known allergies. The patient experienced started with sweating then lightheaded nausea and dizzy, 30 minutes after injection broke out with hives on neck and chest rash on face and blood pressure was elevated on 30Mar2021 10:15. Therapeutic measures were taken as a result of started with sweating then lightheaded nausea and dizzy 30 minutes after injection broke out with hives on neck and chest rash on face and blood pressure was elevated and was taken to hospital for observation. The outcome of the events was recovering.
57 2021-04-12 chest pain Patient received 1st dose of Pfizer COVID vaccine on 3/31/21. Patient developed COVID symptoms ~ 4/3... Read more
Patient received 1st dose of Pfizer COVID vaccine on 3/31/21. Patient developed COVID symptoms ~ 4/3 and tested positive for COVID on 4/9/21. Patient was exposed to someone who was also found to be COVID positive. Patient presented to the ER with fever, cough, congestion, chest pain, body aches, and shortness of breath on 4/10/21 and was admitted to the hospital for COVID treatment.
57 2021-04-13 heart attack, atrial fibrillation, troponin increased Patient awoke in the middle of the night (1:20am) with severe discomfort in the neck and throat. Ex... Read more
Patient awoke in the middle of the night (1:20am) with severe discomfort in the neck and throat. Excess saliva. As the pain persisted the pain radiated to the left arm/shoulder. We sought help at our local emergency department where she was found to be in new onset atrial fibrillation. A battery of tests were ordered including a troponin which was noted to be: 1.48. She was transported via ambulance to the hospital to be admitted and undergo left heart cardiac catheterization with the presumptive diagnosis of NSTEMI.
57 2021-04-17 atrial fibrillation Atrial fibrillation; This is a spontaneous report from a contactable consumer (patient). A 57-year-... Read more
Atrial fibrillation; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 25Mar2021 10:30 (Lot Number: ER8733), at the age of 57-years at vaccination, as SINGLE DOSE for COVID-19 immunisation. Medical history included High blood pressure. The patient is not pregnant at the time of vaccination. The patient did not have COVID-19 prior vaccination. Concomitant medications included lisinopril taken for an unspecified indication, start and stop date were not reported; colecalciferol (D3) taken for an unspecified indication, start and stop date were not reported; zinc taken for an unspecified indication, start and stop date were not reported; aspirin [acetylsalicylic acid] (ASPIRIN) taken for an unspecified indication, start and stop date were not reported; fexofenadine hydrochloride (ALLEGRA) taken for an unspecified indication, start and stop date were not reported; amoxicillin taken for an unspecified indication, start and stop date were not reported. On 29Mar2021 12:15, the patient experienced atrial fibrillation 4 days after injection. The event includes emergency room visit and physician office visit. The patient underwent lab tests and procedures which included sars-cov-2 test (Nasal Swab): negative on 29Mar2021. The outcome of the event was unknown. Therapeutic measures were taken as a result of the event which includes IV medication.
57 2021-04-17 blood clot tip of left ring finger turned white and numb/finger was completely white and the rest of her hands ... Read more
tip of left ring finger turned white and numb/finger was completely white and the rest of her hands were blue and red and white and yellow; tip of left ring finger turned white and numb; her finger felt funny; Reynauds phenomenon; sore arm; fever; chills; headache; swollen lymph node in the armpit of the arm she got her Covid 19 vaccine in; swollen lymph node started with a sharp pain and it's very sore; left foot, it was pulsing and throbbing all night; feet were modeled red, blue; feet were modeled red, blue; very sick; needed her glasses trying to give her primary care doctor's phone number; has something like gout in her foot; The swollen lymph node started with a sharp pain and could be a blood clot as far as she knows; This is a spontaneous report from a contactable consumer (patient) via the medical information team. A 57-year-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot: EW0150; expiry: 31Jul2021), via an unspecified route of administration in left arm on 31Mar2021 01:30 as single dose for covid-19 immunisation. The vaccination facility type was a warehouse. The vaccine was not administered at a military facility. No previous immunization with the Pfizer vaccine considered as suspect. No vaccines administered on same date with the Pfizer vaccine considered as suspect. No prior vaccinations (within 4 weeks) and no following prior vaccinations. Medical history included covid-19 in Nov2020. The patient had no concomitant medications. The patient had the first dose of bnt162b2 on 31Mar2021 and 12 hours later (on 01Apr2021), sore arm, fever, chills and headache. Got a swollen lymph node in armpit, same arm as injection left side, today tip of left ring finger turned white and numb. She thinks it was Reynauds phenomenon. The patient called and told nurse in her doctor's office and they said if it was painful, it could be a pain clot. It was painful at first, that lymph node started 24 hours later with a sharp pain, and then she just assumed it could be a lymph node. Swollen lymph node started with a sharp pain and it was very sore. The nurse told the patient to call Pfizer. The patient was fine until the tip of her finger happened. The patient said If it was painful it could be a blood clot, would need an x ray and asked if did the shot cause this. The complete ring finger left hand, the patient looked it up and it said it could happen to her feet and she looked, and her feet were modeled red, blue it was bizarre. Never happened before. The patient was not happy about getting the vaccine, she already had covid in November of last year (2020). The patient wouldn't have called if it wasn't for her finger. Not just her feet, her hands got like this too. The patient didn't want to get the second shot. The patient asked if there was any information or mandate on timing information for the second dose, should she needed to postpone it. The patient asked if what was the efficacy after first dose as she felt like she was immune because she had the virus and now the vaccine. She was very hesitant to get the Covid 19 vaccine. She thinks her body created Covid 19 antibodies. A couple days ago she was very sick. The swollen lymph node started with a sharp pain and could be a blood clot as far as she knows (in 2021). Even putting on deodorant she can tell it's there, it was very sore and there's a lump. Today (on 01Apr2021), she noticed the tip of her finger got white it was numb. She looked it up online and she thinks it was Reynaud's phenomenon. She has a picture if Pfizer needed it. The finger was on the same arm that she received her vaccine in. It was the ring finger on left hand. Once it started happening her finger felt funny and felt numb. She put her finger under warm water. She reported that the white color was maybe a third of the way down towards her knuckle. She was asking if this was normal or has this been reported. She had called her doctor today and spoke with the nurse who told her to call the CDC and report her symptoms. She needed her glasses trying to give her primary care doctor's phone number. The patient wanted to add that she has something like gout in her foot and on that side too, the left foot, it was pulsing and throbbing all night. She's had this pain in her left foot, she thinks its gout because it was all the symptoms of gout and she had it for a while, it hurts off and on but that night it was hurting and throbbing. She has not been diagnosed with gout in that left foot. She still has a headache but today she felt good except for her finger turning white and going numb. The lymph node in her armpit hurts. Her doctor's nurse told her if its painful to the touch it could be a blood clot so she was nervous about that. The tip of her finger was completely white and the rest of her hands were blue and red and white and yellow. She reported that her finger was back to normal now. She didn't want to get too inoculated since she also had the Covid 19 virus. The events did not require visit to emergency room nor physician office. The outcome of the events was unknown for thrombosis, Raynaud's phenomenon, erythema, cyanosis, illness, visual impairment, and gout while for the remaining events was recovering.
57 2021-04-24 platelet count decreased Swelling at the injection site; Her arm was the size of an egg and it was hard; A significant drop i... Read more
Swelling at the injection site; Her arm was the size of an egg and it was hard; A significant drop in her platelet level; She was tired for 24 hours; This is a spontaneous report received from a contactable consumer (patient) and via a Pfizer-Sponsored program. A 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 25Mar2021 (at the age of 57-years-old) as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On 27Mar2021 the patient experienced a significant drop in her platelet level and on unspecified dates the patient experienced swelling at the injection site, her arm was the size of an egg and it was hard and she was tired for 24 hours. The patient stated that she received the first dose of the Pfizer COVID-19 vaccine on 25Mar2021 and she then had routine blood work done on 27Mar2021 (also reported as 29Mar2021) which showed a significant drop in her platelet level. She stated that she normally had a platelet count on the lower side, but the platelets were quite a bit lower than the last bloodwork she had done. She stated that she had blood work last on 24Mar2021 which is why she knew. She stated that her platelets dropped after she got the first dose. She checked the internet for side effects of the vaccine and she did see that some people had reported that a lowered platelet count could happen. She stated that she was doing research to investigate if this was truly a side effect of the vaccine. She wanted to know if this had been reported before. She would like to know before she got the second vaccine. The patient also stated that she also had swelling at the injection site, her arm was the size of an egg and it was hard, and she was tired for 24 hours. The patient wanted to know if she would still need to wear a mask after having received both doses if she decided to go out in public or visit others and she wanted to know how effective the first dose was if she decided not to receive the second dose. The clinical outcomes of the events a significant drop in her platelet level, swelling at the injection site, her arm was the size of an egg and it was hard and she was tired for 24 hours were all unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
57 2021-04-24 fainting possible seizure; fainting; chills; headache; joint and long bone pain; dizziness; Right abdominal p... Read more
possible seizure; fainting; chills; headache; joint and long bone pain; dizziness; Right abdominal pain; temperature spike at 101; unquenchable thirst; sweating; This is a spontaneous report from a contactable consumer (patient) reported for herself that the 57-year-old female patient received second dose of bnt162b2 (BNT162B2), intramuscular, administered in Arm Right on 08Apr2021 04:00 PM (Lot Number: EW0151) at single dose for covid-19 immunization. Medical history included multiple allergies from an unknown date and unknown if ongoing, asthma from an unknown date and unknown if ongoing, chronic obstructive pulmonary disease from an unknown date and unknown if ongoing, orthostatic hypotension from an unknown date and unknown if ongoing , traumatic lung injury from an unknown date and unknown if ongoing , metaplasia from an unknown date and unknown if ongoing , hiatus hernia from an unknown date and unknown if ongoing , polyp from an unknown date and unknown if ongoing , diverticulum intestinal from an unknown date and unknown if ongoing , exposure to toxic agent from an unknown date and unknown if ongoing. Concomitant medications included pantoprazole taken for an unspecified indication, start and stop date were not reported; famotidine taken for an unspecified indication, start and stop date were not reported; cyclobenzaprine taken for an unspecified indication, start and stop date were not reported; calcium carbonate;soya isoflavones;vitamin d nos taken for an unspecified indication, start and stop date were not reported; ibuprofen;phenylephrine hydrochloride taken for an unspecified indication, start and stop date were not reported. The patient previously took firs dose of bnt162b2 (BNT162B2) intramuscular, administered in Arm Right on 18Mar2021 04:15 PM(Batch/Lot Number: ER2613) at single dose for covid-19 immunisation. The patient experienced possible seizure on 08Apr2021 20:00 with outcome of recovering , chills on 08Apr2021 with outcome of recovering , headache on 08Apr2021 with outcome of recovering , joint and long bone pain on 08Apr2021 with outcome of recovering , dizziness on 08Apr2021 with outcome of recovering , fainting on 08Apr2021 with outcome of recovering , right abdominal pain on 08Apr2021 with outcome of recovering , temperature spike at 101 on 08Apr2021 with outcome of recovering , unquenchable thirst on 08Apr2021 with outcome of recovering , sweating on 08Apr2021 with outcome of recovering. The patient underwent lab tests and procedures which included body temperature: temperature spike at 101 on 08Apr2021. Therapeutic measures were taken as a result of possible seizure. She is not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The clinical course was reported as follows: 4 hrs post vax: chills, sub normal temperature drop >96 f oral, eat, and airmpit , sub normal low BP, headache, joint and long bone pain, dizziness, 2 episodes of warned fainting (vasovagal); followed by temperature spike at 101 F oral onset @21 hrs. post vax riggors and falls, with warned loss of consciousness & possible seizure, followed by lower right abdominal pain w/rebound tenderness, sweating, unquenchable thirst, until fever broke 30 hrs post onset. At febrile onset 400 mg ibuprofen, followed by 200 mg every 8 hrs until symptom resolution. The adverse event result in any of the following Doctor or other healthcare professional office/clinic visit. Treatment was received for the adverse event included Public Health RN telephone consult, ibuprofen see. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Allergies to medications, food, or other products:Yes a long list that does not include PG. Other diagnosed illnesses/medical history/chronic health conditions:IMMUNE SYSTEM: multiple allergies including anaphylaxis; R.A., reactive asthma; CARDIOPULMONARY: reactive asthma, chemical exposure lung injury scaring, COPD, orthostatic hypotension; GI: Barrets esophagial metaplasia, hiatal hernia, colonic polyps adenocarcinoma, diverticula. Follow-up (20APR2021): Follow-up attempts completed. No further information expected.
57 2021-04-24 palpitations symptoms were intensified by first COVID vaccine; heart pain; severe fatigue; pain in head; heart pa... Read more
symptoms were intensified by first COVID vaccine; heart pain; severe fatigue; pain in head; heart palpitation; brain fog; This is a spontaneous report from a contactable consumer (patient). A 57-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in the left arm on 19Mar2021 12:30 (lot number and expiration date were not reported) as single dose (at the age of 57-years-old) for COVID-19 immunisation. Medical history included gastrooesophageal reflux disease (GERD), irritable bowel syndrome (IBS), asthma, allergies, early bone loss, allergy to penicillin, latex, lactose and sugar; all from an unknown date and unknown if ongoing. Concomitant medications included ascorbic acid, ergocalciferol, nicotinamide, retinol, riboflavin, thiamine hydrochloride (VITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;NICOTINAMIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]) and unspecified allergy medications. The patient previously took codeine and experienced allergies. The patient had no other vaccine in four weeks prior to vaccination. It was unknown if the patient had COVID prior to vaccination. On 23Mar2021, the patient experienced heart pain, severe fatigue, pain in head, heart palpitation and brain fog. The patient described the events as having "long hauler" symptoms since 23Oct2020. The symptoms were intensified by first COVID vaccine. Four days after the first shot, the patient had severe fatigue, heart palpitation, heart pain, pain in head through out day which comes and goes and brain fog. The symptoms intensified and remained for 18 days after first shot. The patient had the second shot on 09Apr2021 on the left arm (lot number was unknown) and had no head pain for the first time since last Oct2020. The patient was not COVID tested post vaccination. The patient had a visit to a doctor or other healthcare professional office/clinic. There were no treatment given. The patient recovered with lasting effects on an unspecified date. Information on the lot/batch number has been requested.
57 2021-04-28 cerebrovascular accident Diagnosed with cryptogenic posterior cerebellar CVA; severe dizziness; vomiting; arm pain; severe ge... Read more
Diagnosed with cryptogenic posterior cerebellar CVA; severe dizziness; vomiting; arm pain; severe general back pain; This is a spontaneous report from a contactable healthcare professional (patient). A 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL9261), via an unspecified route of administration, administered in left arm on 20Jan2021 13:30 (at the age of 57 years old) as single dose for COVID-19 immunisation, at a workplace clinic. Medical history included hypertension (HTN) and depression, both from an unknown date and unknown if ongoing. The patient has no history of COVID prior vaccination. The patient has no known allergies. Concomitant medications included sertraline hydrochloride (ZOLOFT); and benazepril hydrochloride, hydrochlorothiazide (BENAZEPRIL/HCTZ) both taken for an unspecified indication. On 22Jan2021 the patient experienced arm pain and severe general back pain. On 23Jan2021, the patient experienced severe dizziness and vomiting. She went to urgent care and symptoms were treated. The patient was advised to have follow-up with the patient's professional care provider; she had MRI and CT angio of head on an unknown date with unknown results. The patient was diagnosed with cryptogenic posterior cerebellar CVA on 23Jan2021. Due to the events, the patient was recommended to have full diagnostic working including cardiac and neuro workup as treatment. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, and hospitalization for three days. The patient underwent lab tests and procedures which included CT angio of head and magnetic resonance imaging (MRI): both with unknown results on an unknown date, and Nasal Swab: negative on 12Apr2021. The patient was recovering from the events.; Sender's Comments: Based on the information provided by the reporter, it appears unlikely that vaccine BNT162B2 contributed to the reported events; these are likely intercurrent medical conditions in this patient with underlying hypertension. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
58 2020-12-31 palpitations Hands turned red with slight swelling. Face and chest with red blotches. Nausea and pounding heart ... Read more
Hands turned red with slight swelling. Face and chest with red blotches. Nausea and pounding heart rate. This is the same symptoms I experience if I drink alcohol. I drank water and it got better in an hour. At night, my scalp was itching all nite. My scalp was red on the right side only which was the site of the vaccine. It is now 2 days later; the itching is gone but scalp has red blotches although they have faded at lot.
58 2021-01-03 heart attack, heart rate increased 12/17/2020 VACCINE 12/18/2020 SWOLLEN LYMPHNODES IN GROIN, FATIGUE 12/21/2020 EXPERIENCED A STEMI;... Read more
12/17/2020 VACCINE 12/18/2020 SWOLLEN LYMPHNODES IN GROIN, FATIGUE 12/21/2020 EXPERIENCED A STEMI; RUSHED TO ER; FELT LIKE COULDN'T BREATHE, INCREASED HR CARDIAC CATH
58 2021-01-03 blood pressure increased, chest discomfort 15- 20 min following injection - heaviness in chest, 2-3 hours later - became flush, elevated blood ... Read more
15- 20 min following injection - heaviness in chest, 2-3 hours later - became flush, elevated blood pressure 169/92, pulse 100. Increased difficulty breathing.
58 2021-01-03 palpitations, chest pain, fast heart rate 30 minutes after receiving vaccine, patient reported heart racing, dizziness, flushing, burning pain... Read more
30 minutes after receiving vaccine, patient reported heart racing, dizziness, flushing, burning pain in her chest, dizziness. tachycardia, nausea and throat tightness; 30 minutes after receiving vaccine, patient reported heart racing, dizziness, flushing, burning pain in her chest, dizziness. tachycardia, nausea and throat tightness; 30 minutes after receiving vaccine, patient reported heart racing, dizziness, flushing, burning pain in her chest, dizziness. tachycardia, nausea and throat tightness; 30 minutes after receiving vaccine, patient reported heart racing, dizziness, flushing, burning pain in her chest, dizziness. tachycardia, nausea and throat tightness; 30 minutes after receiving vaccine, patient reported heart racing, dizziness, flushing, burning pain in her chest, dizziness. tachycardia, nausea and throat tightness; 30 minutes after receiving vaccine, patient reported heart racing, dizziness, flushing, burning pain in her chest, dizziness. tachycardia, nausea and throat tightness; 30 minutes after receiving vaccine, patient reported heart racing, dizziness, flushing, burning pain in her chest, dizziness. tachycardia, nausea and throat tightness; This is a spontaneous report from a contactable pharmacist. A 58-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number= EH9899), intramuscular on 19Dec2020 07:00 at SINGLE DOSE at Left arm for covid-19 immunization. Medical history included breast cancer female and allergies to shell fish and Latex. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. 30 minutes after receiving vaccine on 19Dec2020 07:30 am, patient reported 'heart racing, dizziness, flushing, burning pain in her chest, dizziness. tachycardia, nausea and throat tightness. Patient was taken to the ED where she received IV Benadryl and was observed for 4 hours. Patient was discharged home and symptoms subsided. The events resulted in emergency room/department or urgent care. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. Outcome of the events was recovered in Dec2020.; Sender's Comments: There is a plausible temporal relationship between immunization and onset of allergic reaction in a subject with a positive medical history for allergy to food (shellfish); causality cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
58 2021-01-04 heart rate increased Elevated heart rate, headache; Elevated heart rate, headache; This is a spontaneous report from a co... Read more
Elevated heart rate, headache; Elevated heart rate, headache; This is a spontaneous report from a contactable other Healthcare Professional (HCP, patient). This 58-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EK5730), intramuscular, on 29Dec2020 at 12:30 PM at single dose for COVID-19 immunisation. Vaccine location was right arm. The patient was vaccinated at hospital, age at vaccination was 58-years-old. No other vaccine was received in four weeks. Medical history was unknown. Concomitant medications included rosuvastatin calcium (CRESTOR) and lisinopril. On 29Dec2020 at 04:00 PM, the patient experienced elevated heart rate, headache. The event was reported as non-serious. Outcome was recovered on Dec2020. No treatment was received for the event. No follow up attempts are possible. No further information is expected.
58 2021-01-04 cardiac arrest, fainting Vaccine received at about 0900 on 01/04/2021 at her place of work, Medical Center, where she was emp... Read more
Vaccine received at about 0900 on 01/04/2021 at her place of work, Medical Center, where she was employed as a housekeeper. About one hour after receiving the vaccine she experienced a hot flash, nausea, and feeling like she was going to pass out after she had bent down. Later at about 1500 hours she appeared tired and lethargic, then a short time later, at about 1600 hours, upon arrival to a friends home she complained of feeling hot and having difficulty breathing. She then collapsed, then when medics arrived, she was still breathing slowly then went into cardiac arrest and was unable to be revived.
58 2021-01-04 palpitations intermittent Heart palpitations that began at 0800; Severe fatigue that began 4 hours post injection... Read more
intermittent Heart palpitations that began at 0800; Severe fatigue that began 4 hours post injection and lasted approx 48 hrs; This is a spontaneous report from a contactable nurse (patient). A 58-year-old female patient received their first dose of BNT162B2 (lot number: Ek 5730; expiry date not reported), intramuscularly on the right arm on 26Dec2020 at 08:30 at single dose for COVID-19 immunization. Medical history included known allergies to milk and eggs. Concomitant medication included lisinopril. The patient experienced severe fatigue that began 4 hours post injection and lasted approx. 48 hrs on 26Dec2020 and intermittent heart palpitations that began at 08:00 on 28Dec2020. The patient recovered from severe fatigue on an unspecified date in Dec2020 (reported as approx. 48hrs) while the outcome of intermittent heart palpitations was unknown.
58 2021-01-05 palpitations, blood pressure increased, fast heart rate Tachycardia, palpitations, elevated blood pressure, feeling faint, nausea, flushing
58 2021-01-06 heart rate increased, palpitations Approx 2 min after getting vaccine I felt lightheaded. I noticed my heart was pounding and racing. ... Read more
Approx 2 min after getting vaccine I felt lightheaded. I noticed my heart was pounding and racing. I got help and Sat in office with nurse. My pulse was 140's ,I felt sweaty and shaky. Whole episode lasted approx 10 minutes
58 2021-01-07 heart rate increased 5 minutes after injection, face red, sudden onset of flushing sensation in chest followed by dizzine... Read more
5 minutes after injection, face red, sudden onset of flushing sensation in chest followed by dizziness and a feeling of rapid heart beat. Throat tightness and difficulty swallowing. Flushing sensation and feeling of rapid heart beat resolved within a few minutes, but left with nausea, flushing and difficulty swallowing/throat tightness.
58 2021-01-10 fainting Fatigue, muscle aches, mental fogginess, syncope, cold hands
58 2021-01-10 loss of consciousness tired; no energy; low back pain; her fingers are hurting; passed out on toilet; Nauseated; hit head ... Read more
tired; no energy; low back pain; her fingers are hurting; passed out on toilet; Nauseated; hit head on wall, head just hurts; hit head on wall, head just hurts; Chills; she was very cold; could not sleep good; site of vaccine was sore; Muscle pain; Joint pain; This is a spontaneous report from a contactable consumer. A 58-year-old female patient started to receive first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: EK9231) by injection once to left arm, via an unspecified route of administration on 04Jan2021 12:30 at single dose for covid-19 immunisation. Medical history included thyroid disorder. Concomitant medication included levothyroxine sodium (SYNTHROID) for thyroid disorder; patient started it after she had her son, and her son is 18 years old. The patient had her vaccine yesterday (04Jan2021) at 12:30, and at nighttime, around 22:00, she started having chills, she was very cold, so she went to bed, she could not sleep good, she kept waking up, and the site of vaccine was sore, she had muscle pain, joint pain, she didn't have fever, but she got up late today (05Jan2021), around 11:00, and had breakfast and felt nauseated, so she stopped eating, and she went to the bathroom and passed out on the toilet, when she woke up, she had her nightgown inside the toilet, it was all wet, she felt better, so she stood up and then she woke up again, and was inside the tub, her legs were inside the basin, she was lying down with her back inside the tub, she thinks she hit her head on the wall, and it just hurts, it didn't bleed or nothing. The patient stated she had the paper she was given. Again stated she can not even function. Patient still feels Chills a little bit, not as bad as last night. She is awake now, but she feels very very tired, like she has no energy, she is laying down on couch right now. She kept waking up and noticed this morning, she had low back pain, in the muscles, even her fingers are hurting. Regarding hitting her head on the wall, states she has a terrible headache, not a little pain, she thinks it is because she hurt her head. The patient is supposed to get second vaccination on 25Jan2021. The outcome of events Chills, Joint pain and nauseated was recovering; of events site of vaccine was sore and muscle pain was not recovered; of other events was unknown.
58 2021-01-11 loss of consciousness Chattering teeth, chills, fever 100.4, lightheaded, dizzy, black out fall to floor, body aches, mild... Read more
Chattering teeth, chills, fever 100.4, lightheaded, dizzy, black out fall to floor, body aches, mild headache, cotton headed, fatigue, left arm pain, neck/shoulder aches
58 2021-01-11 blood pressure increased Vaccine Adverse Event Reporting System, I received the first Pfizer Vaccine (EH9899) on 12/19/20. ... Read more
Vaccine Adverse Event Reporting System, I received the first Pfizer Vaccine (EH9899) on 12/19/20. A few days later, I felt like my head, on the side of my right ear, had a great deal of pressure in it and it felt "funny " but it did not really hurt. It was uncomfortable and distracting. I waited to see if it would go away. I noticed my hearing was decreased . On 01/06/20 when I woke up, my hearing was completely gone in my right ear. I could hear nothing out of that ear. I had a noise in my head. Just a loud roaring noise. I had severe vertigo and could not walk across the room. I describe this as I felt like I was on a merry-go-round and someone was spinning me really fast. (continue) Additional information for Item 18: Vaccine Adverse Event Reporting System, continued: I also experienced severe vomiting and could not stop. My husband took me to the doctor. Since I could not get in to my regular doctor that day, we went to an ear doctor I had visited a couple of years ago because that was the only person I could find to see me on short notice. I had regular hearing test in the past and my hearing was normal last time he checked it. After doing a hearing test, he verified my Hearing was severely decreased in my right ear. I explained to him, I also feel "foggy" and I have problems concentrating, was having vertigo, and vomiting. I am not sure if that is because of the constant sound in my ear that distracts me but it is a definite problem and interferes with my work. I cannot concentrate. He started me on Steroids (Prednisone) 60 mg a day for 7 days, then 40 mg for 3 days, then 20 mg for three days, Antivert 12.5 mg three times a day as needed, and Zofran for the vomiting if I needed that. I have not experienced anymore vomiting and the Vertigo has been very limited. Mostly when I lay down now instead of when I stand up. My blood pressure has also been slightly elevated, but it could be from the Steroids. I was scheduled to take the 2nd Pfizer Vaccine on 01/09/21. Since I was receiving the high doses of Steroids, I was concerned that the vaccine would not be effective or may interact with the steroids so I went to my family doctor 01/08/21, for a visit. He said he would check and let me know if it was contraindicated for me to take the Vaccine on high doses of steroids. When I did not hear from him, because I had to take the vaccine the next day, I called the Pharmacy and talked to someone there and they told me the agency was still recommending you take the Vaccine even if you are on the steroids. I received the second Pfizer Vaccine on 01/09/21. My hearing is now coming and going but I can hardly hear anything out of that right ear. . There is a constant noise, like a roaring, in my head and I still have problems concentrating. I have had no more vomiting and my vertigo has hot been as severe but I have experienced some at times. I reported to the Pharmacy the day I received my vaccine, 01/09/21, about the things I had experienced this since my first vaccine. They took my information and said they would call me but today is 01/12/21 and I have not heard from them yet so I thought I would go ahead and report this. I am concerned this was an adverse reaction to the vaccine. I return to the doctor 01/20/21 for a repeat hearing exam. The Doctor expressed this condition could be a permanent and disabling issue but currently being treated and will follow up with more testing. I am also concerned about how the second vaccine affected me because I was receiving the high doses of Steroids at the time I received it. I am sending this from a work email so if you reply, please reply to personal email.
58 2021-01-12 hypotension Systemic: Chills-Mild, Systemic: Vomiting-Mild, Systemic: hypotensive, heat flashes, dizziness, (pat... Read more
Systemic: Chills-Mild, Systemic: Vomiting-Mild, Systemic: hypotensive, heat flashes, dizziness, (patient recovered before leaving for ER, only sent due to past cardiovascular events)
58 2021-01-13 palpitations Heart Palpatations started first lasted about 15 minutes, then sore throat, congestion, body aches ... Read more
Heart Palpatations started first lasted about 15 minutes, then sore throat, congestion, body aches and severe fatigue, injection site pain and chills.
58 2021-01-13 blood pressure increased Within minutes of receiving first COVID vaccine, patient experienced a feeling of warmth, lighthead... Read more
Within minutes of receiving first COVID vaccine, patient experienced a feeling of warmth, lightheadedness and elevated blood pressure of 210/110. BP down to 170/100 at the time of leaving appointment (20 minutes after shot). The next day she felt nausea, Ha, body aches and burning sensation down the arm of the injection.
58 2021-01-14 palpitations Pt stated that she felt her heart racing. She denied any other symptoms. She was walked over to the ... Read more
Pt stated that she felt her heart racing. She denied any other symptoms. She was walked over to the EMS area and placed on heart monitor and monitored for another 20 minutes.
58 2021-01-15 chest discomfort The patient received the vaccine and went to sit for a 15 minute rest period. 5-10 minutes after she... Read more
The patient received the vaccine and went to sit for a 15 minute rest period. 5-10 minutes after she sat down, she stated she had swollen fingers and hands, and felt chest tightness. She was then transported to the ED in a wheelchair.
58 2021-01-17 fainting Sore arm x 2-3 days, itching arm started on 1/15 through 1/16, tingling lips for the first hour afte... Read more
Sore arm x 2-3 days, itching arm started on 1/15 through 1/16, tingling lips for the first hour after vaccine, felt fatigued the day of the vaccine for about an hour after, On 1/14 at 0530 woke up with a horrible right calf cramp was relieved by massage. Sat at side of bed began feeling extremely nauseated, diaphoretic then syncopal episode that lasted approximately 5 seconds.
58 2021-01-18 chest pain Severe generalized muscle pain and weakness, general bone pain, general organ pain, short of breath,... Read more
Severe generalized muscle pain and weakness, general bone pain, general organ pain, short of breath, itching, severe chills alternating with fever, chest pain, facial nerve numbness, blurry vision, sore throat, nausea, diarrhea. Treatment was a Medrol Dose pack for 6 days. Outcome was severe symptoms decreased after 4 hours of taking first dose (6 tabs) of prednisone. As the prednisone dose decreases each day there is increased muscle pain and shortness of breath/lung tightness with activity, and severe fatigue
58 2021-01-19 pulmonary embolism, heart attack, deep vein blood clot 1/4/21- Patient stated she had tenderness on the back of her left lower leg with redness then 1/8/21... Read more
1/4/21- Patient stated she had tenderness on the back of her left lower leg with redness then 1/8/21 started to have shortness of breath and made a doctor's appointment for 1/13/21. Seen by provider on 1/13/21 and was sent to ED and admitted to the hospital [ICU] with NSTEMI, acute deep, occlusive venous thrombosis left femoral vein and saddle embolus of pulmonary artery. Transferred to another acute care hospital for removal of thrombosis. Patient started on Eliqus and no intervention for removal of the thrombosis.
58 2021-01-19 loss of consciousness I began to pass out and yelled for my husband, he said when he came in I was sitting on the toilet w... Read more
I began to pass out and yelled for my husband, he said when he came in I was sitting on the toilet with my head back, eyes rolling back not responsive.; I had my 2nd vaccine at work early Sat the 9th and felt increasingly worse all day; I woke up at midnight and felt extreme malaise; I was covered in sweat; vomited; I checked my temp and it was 99.7°F; sore; I think I had either a seizure or a vasovagal response.; This is a spontaneous report from a contactable nurse (patient). This 58-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot EJ1685 or FJ1685), intramuscular at single dose in the left arm on 09Jan2021 06:00 for Covid-19 immunisation. Medical history included atrial fibrillation on unknown date (1 episode), allergic to Keflex. There were no concomitant medications. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot EJ1685 or FJ1685), intramuscular in the left arm on 22Dec2020 for Covid-19 immunisation. On 10Jan2021 01:00 AM, the patient experienced: I began to pass out and yelled for my husband, he said when he came in i was sitting on the toilet with my head back, eyes rolling back not responsive (loss of consciousness) (medically significant), I had my 2nd vaccine at work early sat the 9th and felt increasingly worse all day (feeling abnormal), Iwoke up at midnight and felt extreme malaise (malaise), I was covered in sweat (hyperhidrosis), vomited (vomiting), I checked my temp and it was 99.7°F (pyrexia), sore (pain), I think I had either a seizure or a vasovagal response (seizure). No treatment required. The outcome of the events was recovered. The events were described as follows: I am healthy RN with no active medical problems. I had my 2nd vaccine at work early Sat the 9th and felt increasingly worse all day, I expected this so was not alarmed and went to bed around 10pm. I woke up at midnight and felt extreme malaise and went to the bathroom in case I might vomit, etc. and I tried to have a BM. I began to pass out and yelled for my husband, he said when he came in I was sitting on the toilet with my head back, eyes rolling back not responsive. He yelled at me for about 10 seconds and I came to, I was covered in sweat. I asked him to walk me back to the bedroom where I again passed out, fell to the floor and hit the bed, then was unresponsive again for about 10 seconds then came to again and vomited. After this I felt completely relieved of my malaise. I checked my temp and it was 99.7°F. After this I was sore but otherwise completely okay, the next day I had a temp of 99.5°F. Today I am back to normal. I think I had either a seizure or a vasovagal response. The vaccine was administered at Hospital Facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient was not pregnant at the time of vaccination.; Sender's Comments: Based on the close temporal relationship, the association between the event "began to pass out" with BNT162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
58 2021-01-19 chest discomfort, chest pain Mild pain & mild pressure on left side of chest
58 2021-01-21 blood pressure increased Lightheadedness, dizziness, blurred vision, elevated BP with normal respiration and pulse, nausea, v... Read more
Lightheadedness, dizziness, blurred vision, elevated BP with normal respiration and pulse, nausea, vomiting, chills, drop in body temp to 96F. Onset 10 mins post injection, increasing over the subsequent hour, subsiding x 1 hr then peaking 5 hrs later, resolved after 12 hours.
58 2021-01-21 heart rate increased This is a spontaneous report from a contactable other healthcare professional (Patient). A 58-year-o... Read more
This is a spontaneous report from a contactable other healthcare professional (Patient). A 58-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number provided as: LAB-1451-0.7), via an unspecified route of administration on 06Jan2021 14:30 at single dose in Left arm for COVID-19 immunization. Medical history included covid-19 from Mar2020 to an unknown date (the patient was sick with the COVID and was super tired). There were no known allergies. The patient's concomitant medications were none (there were no other medications received in two weeks). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced Itching more in the arm in the shot area, extreme joint pain, bones pain, headache, first 2 days dizziness, tiredness extreme, a little cough which all started from 06Jan2021 14:30. The patient also had pain on 2nd and 3rd day (onset date: 07Jan2021). The patient experienced heart beat fast everyday which started from 06Jan2021 14:30. The patient still had her left arm itching and hot as of 11Jan2021 but better with other side effects. Event onset date for her left arm hot was in Jan2021. No treatment received for the adverse events Itching more in the arm in the shot area, extreme joint pain, bones pain, headache, dizziness, tiredness extreme, a little cough, pain, heart beat fast, left arm hot. The patient stated she got the vaccine on Wednesday (06Jan2021) and after that she was feeling this thing but she was thinking was because of the Normal Saline, but in a little bit in the night she was very tired, super tired. Next day on 07Jan2021 she was to getting pain in her bones, very hard on her leg like when she was sick with the COVID last. The next day on 08Jan2021, she was having pain in her joints and her bones and muscles and she got the pain in her arm where she got the vaccine and was red and was like a big bump in her arm there. And next day she thought it was a Sunday morning on 10Jan2021, she had a little red, she had like redness in her face and itchy all her arms. So, and the patient feel very tired, super tired like when she was sick with this COVID-19 last March. She felt much better on 10Jan2021, the pain was a little less and her arm was much better and still itchy. The patient underwent lab test which included heart beat: fast on an unknown date. The outcome of events heart beat fast, got the pain in arm where the patient got the vaccine and was red and was like a big bump in her arm there and Redness of face, pain in muscles was unknown, the outcome of event itchy all her arms was not recovered, the outcome of the other events was recovering. This case reported as non-serious.
58 2021-01-21 blood pressure increased itching all over my face; elevated blood pressure; increased breathing rate
58 2021-01-23 troponin increased, chest pain, palpitations On Jan 22 I had fever, body aches and headache. Woke up on Jan23 and felt fine, no symptoms. At ar... Read more
On Jan 22 I had fever, body aches and headache. Woke up on Jan23 and felt fine, no symptoms. At around 2:30 on Jan 23 I had an argument with someone and felt my heart race for a minute and then chest pain radiating to my back. Went to the hospital at 7pm and was being ruled out for an MI.
58 2021-01-24 chest pain Fatigue, nausea, diarrhea, chest pain
58 2021-01-24 nosebleed On the second day on 12/29/2020 in the afternoon I started feeling fatigue, I hade nose bleeding, fe... Read more
On the second day on 12/29/2020 in the afternoon I started feeling fatigue, I hade nose bleeding, fevers & headaches. On the third day on 12/30/2020 I had hives I had them in my face they were the size of a dime they are lumping I had them on my eyebrows & on my right cheek, & continued nose bleeding, fever continued, fatigue continued, headaches continued, pain on my arm & I felt with no energy. I had a lot of nose bleeding. On 12/30/2020 I called the doctor and they gave me an appointment for 12/31/2020 & they gave me a zoom meeting. The doctor said every symptom I had was a normal reaction to the covid vaccine except the nose bleeding. The symptoms continued but the nose bleeding is the only thing it has stopped.
58 2021-01-25 heart rate increased Felt Lightheaded with fast Heart rate.
58 2021-01-27 palpitations It's an idiosyncratic reaction that happens periodically; flushing; palpitations; shaking chills (vi... Read more
It's an idiosyncratic reaction that happens periodically; flushing; palpitations; shaking chills (violent shaking); difficulty breathing; This is a spontaneous report from a contactable pharmacist. A 58-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection, lot number: EL3246; expiration date not provided), via an unspecified route of administration on 12Jan2021 16:30 at a single dose at left arm for COVID-19 immunisation, glatiramer acetate (COPAXONE), via an unspecified route of administration from an unspecified date at an unknown dose and frequency for unspecified indication. Medical history included multiple sclerosis, hypothyroidism and osteoporosis. The patient was not pregnant. The patient received the first dose of BNT162B2 (lot number: EKS730) on 22Dec2020. The evening after the patient had her second Covid vaccine, the patient gave herself Copaxone shot. On 14Jan2021, the patient stated that there was an idiosyncratic reaction that happens periodically. Symptoms were flushing and palpitations. It ends quickly. About 15 minutes after that occurred, the patient had shaking chills (violent shaking) and difficulty breathing. The symptoms lasted about 1 hour. During that hour, the patient had someone drive her to the hospital but during the drive the symptoms calmed down. The patient spoke with one of the nurses that does screening in the lobby and they said many people had been reacting to their second shots, so she didn't really need to be seen in the ED since her symptoms had resolved. No treatment was received. The action taken in response to the event for glatiramer acetate was unknown. The outcome of the events was recovered on an unspecified date.
58 2021-01-28 heart rate increased Headache; Chills; not feeling well; tingling all over her arms, face and legs; severe fast heartbeat... Read more
Headache; Chills; not feeling well; tingling all over her arms, face and legs; severe fast heartbeat; Dizziness; difficulty breathing; This is a spontaneous report from a contactable consumer. A 58-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL0142, expiry: Mar2021), via an unspecified route of administration on 03Jan2021 at a single dose for covid-19 immunization. The patient has no medical history and no concomitant medications as the patient reported she was healthy. The patient experienced severe reactions, she was in the hospital twice. On 10Jan2021, the patient experienced difficulty breathing, severe fast heartbeat and dizziness. On 13Jan2021, patient had headache, chills, not feeling well, and tingling all over her arms, face and legs. The patient further stated that a week after getting the vaccine, last Sunday, she had a severe reaction and was hospitalized twice due to the events. Exactly one week after receiving the vaccine, on Sunday 10Jan2021, patient ended up in an ambulance due to dizziness, fast heart rate, and difficulty breathing which all started on 10Jan2021. She confirms that she was admitted to the hospital that day, and she was discharged the next day, on 11Jan2021 in the afternoon. On 13Jan2021, in the afternoon, the other symptoms of headache, chills, not feeling well, and tingling all over her arms, face and legs, started. Patient went back to a different hospital, to the emergency room, on Wednesday 13Jan2021, but was not admitted at that time. Patient mentioned the difficulty breathing was okay, but she does not want to say it was 100% better because she was still having a little bit of difficulty. Caller states that the dizziness and fast heart rate are still pretty serious. It was reported that the patient was hospitalized for the event fast heart rate from 10Jan2021 to 15Jan2021, and chills, not feeling well, and tingling all over her arms, face and legs on unspecified date. Patient was due to get the second dose on 24Jan2021, and she does not know if she should because she had side effects to the first dose. Patient seen several doctors and she had a cardiologist that was monitoring her, and she has had a stress test and labs and those are all normal. patient confirms that the product was no specifically prescribed to her, but it was given via workplace policy as she works for a hospital. The outcome of the events difficulty breathing was recovering and not recovered for all the other events. No follow-up attempts are possible; information about batch number has been obtained.
58 2021-01-28 hypertension Left sided weakness, headache, chills, hypertension (normally hypotensive), bradycardia.
58 2021-01-29 fainting 15 seconds after injection patient felt tired and like she was going to pass out. Patient was anxiou... Read more
15 seconds after injection patient felt tired and like she was going to pass out. Patient was anxious appearing. Patient taken to the Emergency Room for further evaluation. Upon presentation to the ER, patient diagnosed with vasovagal syncope, treated with fluids and zofran and discharged home.
58 2021-01-30 cardiac arrest After being observed for approximately 20 minutes and patient walked to her car without assistance I... Read more
After being observed for approximately 20 minutes and patient walked to her car without assistance I was called to assess the patient in the parking lot for troubles breathing. EMS was called as I made my way outside. Upon my arrival patient was leaning out of the car and stating that she could not breath. She was able to tell me that she was allergic to penicillin. Oxygen was immediately placed on the patient with minimal relief. Lung sounds were coarse throughout. She then began to vomit about every 20-30 seconds. Epipen was administered in the right leg with no relief. Patient continued to complain of troubles breathing and vomiting. A second epipen was administered in the patients right arm again with no relief. A few minutes later patient was given racemic epinephrine through the oxygen mask. There appeared to be mild improvement in her breathing as she appeared more comfortable, but still complaining of shortness of breath and vomiting. When EMS arrived patient was unable to transport herself to the stretcher. When EMS and clinical staff transferred patient to the stretcher she became unresponsive. She appeared to still be breathing. She did not respond to verbal stimuli. Per ED report large amount of fluid was suctioned from the patients lungs following intubation in the ambulance. When patient arrived to the ED she was extubated and re-intubated without difficulty and further fluid was suctioned. At that time patient was found to be in PEA, shock was delivered. Shortly thereafter no cardiac activity was found and patient pronounced dead.
58 2021-01-31 fast heart rate Fever up to 102.4, tachycardia to 140, fatigue, chills, pain under left axilla, weakness, generalize... Read more
Fever up to 102.4, tachycardia to 140, fatigue, chills, pain under left axilla, weakness, generalized body aches
58 2021-01-31 platelet count decreased Idiopathic thrombocytopenia Onset Jan 27; platelets dropped to <3000. Good response to decadron wi... Read more
Idiopathic thrombocytopenia Onset Jan 27; platelets dropped to <3000. Good response to decadron with rise to 100,000 by feb 1. No significant bleeding
58 2021-01-31 chest pain Metalic taste in throat Burning in chest lips swelling tongue swelling with swallow difficulty
58 2021-01-31 palpitations Patient received the Pfizer COVID vaccine dose #1 on 1/14/2021 and within 5 minutes of administratio... Read more
Patient received the Pfizer COVID vaccine dose #1 on 1/14/2021 and within 5 minutes of administration the patient developed itching and a flushed feeling, tingling lips, racing heart rate, and headache. Patient reports these symptoms lasted several hours and then resolved.
58 2021-01-31 chest discomfort chest tightness, shortness of breath, then went to throat sore throat, hoarseness patient received E... Read more
chest tightness, shortness of breath, then went to throat sore throat, hoarseness patient received EPIPEN 0.3 mg 3 doses 5 min apart. then went to ER had two breathing treatments, albuterol, epinephrine, solumedrol one injection, 50 mg Benadryl reports rash at IV site from (Benadryl?) No rash anywhere else. Prednisone tapering dose and Benadryl 50 mg at night and 25 during day time. To follow up with PMD. Headache.
58 2021-02-01 chest pain felt a strong pain in the chest; injection site was color purple; injection site was color red, swol... Read more
felt a strong pain in the chest; injection site was color purple; injection site was color red, swollen and with pain; injection site was color red, swollen and with pain; injection site was color red, swollen and with pain; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number not reported, via an unspecified route of administration from 14Jan2021 to 14Jan2021 as SINGLE DOSE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient stated that 2 days after the administration, the injection site was color red, swollen and with pain; 3 days after the administration the injection site was color purple; and 4 days after the administration she felt a strong pain in the chest. The outcome of the events was unknown. Information on lot/batch has been requested.
58 2021-02-03 chest discomfort Fever 101.9 at 18 hours, body aches, headaches, chills, tight chest/throat post 48 hours. Fevers an... Read more
Fever 101.9 at 18 hours, body aches, headaches, chills, tight chest/throat post 48 hours. Fevers and chills back at 48 hours with headaches again.
58 2021-02-03 blood pressure increased patient felt lightheaded within 5 minutes of arriving in observation areas. Vitals upon initial symp... Read more
patient felt lightheaded within 5 minutes of arriving in observation areas. Vitals upon initial symptom reporting BP 158/101, HR 66, O2 sat 97%, temperature 36.9. Patient reported not eating anything this morning prior to arrival at vaccination site. Water, crackers provided. Feet elevated for 30 min and ice packs provided. Vitals 30 min later noted BP 170/78, HR 60, O2 sat 99%. Patient transported to ED via wheelchair with RN for further monitoring.
58 2021-02-03 fainting synopcal event
58 2021-02-04 fainting Syncope 5 - 10 seconds , Nausea, slight head ache, weakness after syncope 2/3 @ 10:15 am Hospita... Read more
Syncope 5 - 10 seconds , Nausea, slight head ache, weakness after syncope 2/3 @ 10:15 am Hospitalized on 2/3 @ 11:30 am on 2/3/2021 2/5 @ 4 :30 pm Primary Care visit @ 3:30 pm on 2/5/2021
58 2021-02-04 hypertension, heart rate increased Systemic: Abdominal Pain-Severe, Systemic: Nausea-Severe, Systemic: Other- High blood pressure and h... Read more
Systemic: Abdominal Pain-Severe, Systemic: Nausea-Severe, Systemic: Other- High blood pressure and heart rate
58 2021-02-08 palpitations, fast heart rate, atrial fibrillation Atrial fibrillation; palpitations; tachycardia/heart rate 141; This is a spontaneous report from a c... Read more
Atrial fibrillation; palpitations; tachycardia/heart rate 141; This is a spontaneous report from a contactable healthcare professional (HCP). This HCP reported similar events for 2 patients. This is 1st of two reports. This 58-year-old female HCP (patient) reported for herself that received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK4176) on 10Jan2021 at 0.3 mL single by intramuscular injection left arm for COVID-19 vaccination. Medical history included ongoing hypertension and diabetes type 2, both diagnosed about 10 years ago (2011). Concomitant medications were not reported. The patient previously received first dose of BNT162B2 (Lot number: EH9899) on 21Dec2020 at single dose for COVID-19 immunisation. The patient reported that a few days after receiving the 2nd dose (on 14Jan2021), she went into atrial fibrillation and had been having palpitations ever since. She had a cardiology appointment in a few weeks and they started her on apixaban (ELIQUIS). Lab data on 14Jan2021 included EKG: normal sinus and Kardiamobile (a medical grade ECG): it showed tachycardia and at least one other time showed atrial fibrillation, heart rate 141. The outcome of palpitations was not recovered, outcome of other events was unknown. Reporter seriousness for atrial fibrillation and palpitations was medically significant.; Sender's Comments: Considering the temporal association, a causal association between administration of BNT162B2 and the onset of atrial fibrillation cannot be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. ,Linked Report(s) : US-PFIZER INC-2021111803 same reporter/drug, similar events, different patient
58 2021-02-10 haemoglobin decreased Hypovolemic shock due to acute intrabdominal hemorrhage of uterine fibroid. Exploratory laparotomy ... Read more
Hypovolemic shock due to acute intrabdominal hemorrhage of uterine fibroid. Exploratory laparotomy and total abdominal hysterectomy and bilateral salpingo-oophorectomy completed within 12 hours of presenting symptoms
58 2021-02-17 cerebrovascular accident admitted to hospital for a stroke
58 2021-02-21 heart rate increased The first symptoms was pain in the injection site. Then felt pain traveling down to my left arm and ... Read more
The first symptoms was pain in the injection site. Then felt pain traveling down to my left arm and fingers. I was told I was only to stay 15 minutes after the shot. On my way home from the vaccination about 30 minutes after the shot, I felt sick. I had a rapid heart rate and itch red hives on my left chest and left palm of my hand. My husband stopped along the road and gave me benadryl. I still had hives the next day. On the third day I had vaginal spotting and I am in menopause and I had extremely bad pain in my left hip, left thigh and left buttocks for 2 weeks. I could not sit or stand up to get relief. I cried with pain and thought I would never recover. I visited a urgent care and he suggested I see a neurologist for the pain. I was tested for covid at that time and was negative. I went to an allergist to see if I am allergic to the PEG in the vaccine. I am not allergic to the compound. She believes my body had a very strong immune response to the vaccine which caused all the symptoms described above. All symptoms were strictly limited to just the left side of my body. I do not know what to do about taking the second dose because I am afraid it will be worse.
58 2021-02-22 chest discomfort Received second Covid vaccine at ~1:45pm and was monitored x 15 minutes without difficulty. She repo... Read more
Received second Covid vaccine at ~1:45pm and was monitored x 15 minutes without difficulty. She reports that about 2:15pm while she was on her way home, she developed some chest fullness/tightness and some mild SOB. She returned to Vaccine clinic for evaluation. She was able to park and walk-in unassisted. Denies throat itching/swelling No rash Vitals: Initial set 115/66, HR 70, RR 18, O2 sat 99% Continuous pulse oximetry with oxygen sats 99-100% and HR 70-75.   Gen: WDWN WF NAD, conversing easily without dyspnea. CV: RRR no MGR Resp: CTA bilaterally, no increased WOB Skin: warm, dry, not diaphoretic, no rash Neuro: afocal,MAE   Fingerstick glucose: 89   Monitored x 15 minutes with significant improvement and resolution of chest discomfort and SOB Discussed with medical director and transferred to employee health for additional 30 minutes of monitoring. Monitored x 30 minutes in SEH. Complete resolution of symptoms. Vitals q 15 minutes x 2 @1513 133/69 HR 71 @ 121/65 HR 72 Cleared to return home. Discussed signs necessitating emergent treatment including chest pain, SOB, throat swelling/itching.
58 2021-02-23 fainting Fainted twice on the sidewalk within an hour and a half of shot. Ambulance was called.
58 2021-02-23 deep vein blood clot, pulmonary embolism Left upper extremity DVT and pulmonary embolism diagnosed 2/24/2021. Arm swelling started 02/23/2021... Read more
Left upper extremity DVT and pulmonary embolism diagnosed 2/24/2021. Arm swelling started 02/23/2021.
58 2021-02-25 chest pain After the second vaccination employee experienced minor symptoms on day 1 and day 2 with headaches, ... Read more
After the second vaccination employee experienced minor symptoms on day 1 and day 2 with headaches, feeling hot/cold alternating, arm pain, muscle aches. Day 3-5, employee became more sick with mild intermittent chest pains, extreme exhaustion, muscle aches and spasms, dizziness, headaches, feeling hot and cold alternating, but no fevers noted. Day 7, employee started to feel better, but symptoms continued with fatigue which persisted for a several days until she was back to baseline
58 2021-02-28 fainting Dizziness, sweating, flushed followed by Syncopal episode, EMS called
58 2021-03-01 blood clot Blood clot in lower left leg; This is a spontaneous report from a contactable consumer (patient hers... Read more
Blood clot in lower left leg; This is a spontaneous report from a contactable consumer (patient herself). A 58-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration on the left arm, at age 58 years, first dose on 23Jan2021 14:00 at single dose for COVID-19 vaccination. Medical history was reported as none. Patient had no known allergies. The patient is not pregnant. There were no concomitant medications. There were no other vaccines administered in four weeks and no other medications taken in two weeks. On 30Jan2021, patient experienced blood clot in lower left leg. ER doc indicated that patient had no reason to have formed a clot given the medical history, health, weight, age, diet, no surgeries, no prior injury, etc. Facility type vaccine was administered at a Public Health Clinic/Veterans Administration facility. Event resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of the event includes rivaroxaban (XARELTO) as blood thinner. The outcome of the event was not recovered. Information about lot/batch number has been requested.
58 2021-03-02 blood pressure increased High temp, ache all over, severe headache,, head to toe all over body edema, systemic body rash and ... Read more
High temp, ache all over, severe headache,, head to toe all over body edema, systemic body rash and itching. Took Benadryl and caused elevated b/p. Went to ER and had steroids.
58 2021-03-02 chest discomfort Swollen tongue, tingling and pain in tongue, difficulty swallowing, heaviness in chest and upper bac... Read more
Swollen tongue, tingling and pain in tongue, difficulty swallowing, heaviness in chest and upper back within 5-10 minutes of injection 1-2 days after, continued tingling, pain, and swelling in tongue, hives/rash on face with itching and difficulty swallowing Benadryl was administered at the testing site. Continued Benadryl with Zyrtec and Pepcid daily for adverse reaction through 3/3/21. Called PCP?have appt 3/4/21.
58 2021-03-02 fainting, hypotension Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Hypotens... Read more
Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Hypotension-Severe, Systemic: Weakness-Severe
58 2021-03-03 oxygen saturation decreased After vaccine, patient developed persistent cough, shortness of breath, and fevers. Was diagnosed wi... Read more
After vaccine, patient developed persistent cough, shortness of breath, and fevers. Was diagnosed with COVID via POCT on 2/25/21 and was discharged from ED given lack of symptoms. Returned 2/27/21 after oxygen saturation found to be ~50% at home. Admitted for severe COVID infection requiring dexamethasone and remains inpatient.
58 2021-03-03 chest pain between the first dose on 1/20/21 a week later I experience pain under my left rib cage and trouble ... Read more
between the first dose on 1/20/21 a week later I experience pain under my left rib cage and trouble catching my breath which I thought was due to shoveling heavy snow, then received my 2nd dose on 2/9/21 and on 2/14/21 I couldn't breathe and pain was so intense and went to Hospital at 9:30 PM and stayed overnight
58 2021-03-04 palpitations Heart palpitations, very cold feeling, chills. Wore full winter clothing in my house and while sleep... Read more
Heart palpitations, very cold feeling, chills. Wore full winter clothing in my house and while sleeping with blankets and a space heater
58 2021-03-04 chest pain Pulse in 160s ... leveled at 150 ... dizziness, confusion, feeling faint, nausea, chest pain, hard t... Read more
Pulse in 160s ... leveled at 150 ... dizziness, confusion, feeling faint, nausea, chest pain, hard to swallow, hard to breath. Taken to ER via ambulance.
58 2021-03-09 palpitations Heart palpitations; sore injection site; body aches in the back; headache; This is a spontaneous rep... Read more
Heart palpitations; sore injection site; body aches in the back; headache; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 58-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number: 013L20A) via an unspecified route of administration on 05Feb2021 08:45 in left arm at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. There was no other vaccine in four weeks. The patient had heart palpitations after vaccine - only lasting a few seconds, sore injection site and body aches in the back - both of which were relieved with naproxen sodium (ALEVE), small headache - went away shortly after getting out of bed. Event onset date reported as 05Feb2021 12:30. Treatment received for the events. The outcome of the event heart palpitations was recovered on 05Feb2021, of other remain events was recovered in Feb2021.
58 2021-03-17 chest discomfort extremely weak; right shoulder pain; temp started rising & by 2PM it was up to 102.4; legs were like... Read more
extremely weak; right shoulder pain; temp started rising & by 2PM it was up to 102.4; legs were like jelly; felt unsteady & like I would fall; felt so bad/felt awful/talking about end of life wishes; no appetite; chest tightness; This is a spontaneous report from a contactable other health care professional reported for herself. A 58-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not available), via an unspecified route of administration on 09Feb2021 16:30 (at the age of 58-year-old) at single dose in left arm for covid-19 immunization. Medical history included Heart Failure, Sarcoidosis, Asthma, Obesity and Covid from Apr2020 to an unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19, since the vaccination, the patient had not been tested for COVID-19. Concomitant medications the patient received within 2 weeks of vaccination included prednisone, carvedilol (COREG), spironolactone (ALDACTONE), hydrochlorothiazide, lisinopril (LISINOPRIL/HCTZ). The day of injection on 09Feb2021 at 16:30 PM that same night 8 pm the patient started experiencing some chest tightness. Since the patient live in country when she left work(hospital). At that point she took 50mg of P.O. benadryl (diphenhydramine). So the patient just took time and hung around town. She went to family dollar then publix. She felt better at 9 pm so and went home. The next morning (on 10Feb2021 her legs were like jelly when she woke up to go to bathroom. She felt unsteady and like she would fall. Next thing she just felt so bad and no appetite so she ate nothing that day. Her temp started rising and by 2PM on 10Feb2021 it was up to 102.4, the patient felt so awful then the feeling of doom set in so she was talking about end of life wishes. She had Covid back in Apr2020 and it was like reliving it again. On 11Feb2021 she felt better but had to call out low grade 99.4 only she was able to eat some but extremely weak and right shoulder pain (moderate). Friday (on 12Feb2021) she went to work but still felt weak. She felt better over the weekend (Feb2021). Here we were 17Feb2021 and still not completely there but 90% better. The adverse events result in doctor or other healthcare professional office/clinic visit. No treatment received for other adverse event. The patient underwent lab tests and procedures which included body temperature: 102.4 on 10Feb2021, body temperature: 99.4 on 11Feb2021, Nasal Swab Covid-19/SARS: negative on 16Feb2021. The outcome of the events was reported as recovered in Feb2021. Information on the lot/batch number has been requested.
58 2021-03-18 atrial fibrillation night before (second dose) she was in atrial fibrillation; was tired but she didn't sleep the night ... Read more
night before (second dose) she was in atrial fibrillation; was tired but she didn't sleep the night before second dose/exhausted; was tired but she didn't sleep the night before second dose/exhausted; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9269; Expiration Date: 31May2021), intramuscularly, administered in left arm on 29Jan2021 as single dose for COVID-19 immunisation. Medical history included ongoing atrial fibrillation (has a pre existing atrial fibrillation), patient also has under active thyroid from unspecified date. The patient's concomitant medications included magnesium taken daily from an unspecified date and for unknown indication, an unspecified medication for atrial fibrillation and an unspecified low dose medicine for cholesterol. The patient previously received the second dose of unspecified shingles vaccine on an unspecified date for immunization and felt sore arm maybe a little under the weather. On 22Feb2021, the night before the second dose of vaccine, patient reported she was in atrial fibrillation, she was tired but she didn't sleep the night before second dose because she was in atrial fibrillation and was exhausted. She took extra of her atrial fibrillation medications. She does not think she took Tylenol after first one. Does not think arm was sore after the first one. The patient was vaccinated at a mass vaccination site. The events did not require emergency room or physician's office visit. The outcome of the events was unknown.
58 2021-03-22 fainting faint; blurred vision; vomit; diarrhea; hot sweats; weakness; This is a spontaneous report from a co... Read more
faint; blurred vision; vomit; diarrhea; hot sweats; weakness; This is a spontaneous report from a contactable consumer (patient herself). A 58-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; batch/lot number and expiration date were unknown), via an unspecified route of administration, administered in the left arm on 05Mar2021 at 16:00 as a single dose for COVID-19 immunization. The vaccination facility type was reported as health clinic. Relevant medical history included overweight from an unknown date and unknown if ongoing. The patient had no known allergies. Concomitant medications included fluoxetine hydrochloride (PROZAC) and omeprazole (PRILOSEC); both were taken for an unspecified indication, start and stop date were not reported. The patient had no other vaccine in four weeks. The patient was not pregnant at the time of vaccination. The patient had no COVID prior vaccination. The patient was not tested for COVID post vaccination. On 05Mar2021 at 21:15, the patient experienced faint, blurred vision, vomit, diarrhea, hot sweats, and weakness. The patient did not receive any treatment for the adverse events (AE). The patient was recovering from all the events. Information on the batch/lot number has been requested.
58 2021-03-28 platelet count decreased She received the vaccine on March 23. On March 28 she felt unwell and early on March 29, 2021 devel... Read more
She received the vaccine on March 23. On March 28 she felt unwell and early on March 29, 2021 developed severe headache and came to the Medical Center ER. She had a large intracranial hemorrhage. Platelet count was 4,000. She had a normal platelet count in December 2020. She had not received chemotherapy for her breast cancer, only radiation. The hemorrhage rapidly expanded. She was intubated and admitted to the ICU under my care. Her husband opted for palliative extubation and she died soon after.
58 2021-03-30 blood pressure increased Extreme pain in left side of back below ribs, prescribed a pain medication Myalgia swelling in feet ... Read more
Extreme pain in left side of back below ribs, prescribed a pain medication Myalgia swelling in feet and legs bleeding in left eye conjunctiva hemorrhage I was tested by blood urine and CT of Aorta and nothing was found to be the cause of the pain or bleeding except the blood pressure was elevated. I told Doctor I had the covid shot and began experiencing the symptoms the next day. I took all my medications and did not have a problem with the pressure. She could find no physical outside of covid cause and sent me home the next morning.Symptoms began 3/27/21 and I was in the ER by 6pm on 3/29/21 and stayed until 3/30/21.
58 2021-03-30 chest discomfort, troponin increased Patient felt pressure on chest & weakness on inside of left are in the bicep area shortly after gett... Read more
Patient felt pressure on chest & weakness on inside of left are in the bicep area shortly after getting up at 6 am 3/29/2021. Slight light-headedness was felt shortly afterwards. Symptoms did not change after moving around & on the advice of patient's insurance company's Nurse Line, she went to the Emergency Room shortly after 7 am. Patient underwent a heart catheterization that day (3/29/2021) and a cardiac MRI the following day (3/30/2021). Cardiologist informed patient he suspected either Stress Cardiomyopathy or Myocarditis. Patient was discharged 3/31/2021 with 4 medications and follow-up appointments scheduled
58 2021-03-30 pulmonary embolism bilateral pulmonary emboli; This is a spontaneous report from a contactable Physician. A 58-year-old... Read more
bilateral pulmonary emboli; This is a spontaneous report from a contactable Physician. A 58-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration Date: unknown) via intramuscular in the left arm on 05Mar2021 10:15 AM at single dose for COVID-19 immunization. The patient's medical history included psoriatic arthritis and asthma. Patient had no known allergies. Concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration Date: unknown) on 12Feb2021 for COVID-19 immunization. On 09Mar2021 17:00 (5.00 PM), the patient experienced bilateral pulmonary emboli, which resulted in emergency room/department or urgent care, life threatening illness (immediate risk of death from the event), disability or permanent damage. The patient received blood thinners as treatment for the event. The outcome of the event was not recovered. Information on the lot/batch number has been requested. ; Sender's Comments: Based on current information available, the event bilateral pulmonary emboli mostly represented intercurrent condition in this patient with advanced age, unrelated to Bnt162b2. Relevant medical history and concurrent treatments are missing for a medically meaningful assessment.
58 2021-04-01 hypotension 3/22/2021 - took double usual dose of hydrocortisone (20mg) prior to receiving vaccine, 7 hours afte... Read more
3/22/2021 - took double usual dose of hydrocortisone (20mg) prior to receiving vaccine, 7 hours after vaccination - chills, body ache, headache, lethargy. 3/23/2021 - woke with nausea and anorexia, took triple usual hydrocortisone dose (30mg) with yogurt, very lethargic, brain fog with cognitive difficulty, anorexia, stayed in bed all day, eating drinking veyr little. 3/24/2021 - woke with worsening lethargy, generalized weakness, nausea, took hydrocortisone 30mg with yogurt. by noon, very dizzy and weak, unable to get out of bed, friend drove her to Hosp. Emergency Room. Noted hypotension systolic BP 80, clinically dehydrated, Na 129, K 3.2, cr 1.2 (nl 0.97) Diagnosed Adrenal Crisis admitted 3 days to 3/27
58 2021-04-04 chest pain, troponin increased 4am, 4/3/21, chest pain unresponsive to 2 chewed Gaviscon. 5 baby ASA taken po and drove to hospita... Read more
4am, 4/3/21, chest pain unresponsive to 2 chewed Gaviscon. 5 baby ASA taken po and drove to hospital ED at 4:30am. First EKG negative for changes. First tryponin lab 0 and negative. Approximately noon, 2nd tryponin elevated at 0.54. Right radial access heart catheterization at approximately 1pm shows small branch of LAD with SCAD. Medical management with IV heparin, Plavix, and daily baby ASA 81mg. Discharged to home 4/4/21.
58 2021-04-09 loss of consciousness developed acute delirium; redness in arm; Right arm swelling; After that very wild, I was screaming.... Read more
developed acute delirium; redness in arm; Right arm swelling; After that very wild, I was screaming. Very scary. My memory was gone; she passed out at home; she is very depressed has anxiety; she is very depressed has anxiety; panic attack; gained 16 pounds; vomited; loss of appetite; body ache/pain; This is a spontaneous report from a contactable Other HCP (patient). A 58-years-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: NN6206 and expiration date: Not available), via an unspecified route of administration in the right arm on 04Mar2021 12:00 as a single dose for COVID-19 immunisation. Medical history included removed brain tumor, she has sciatic nerve damage on left arm and left leg and is paralyzed, coma, chronic body aches, seizures, bad vision, high blood pressure and three brain surgery, short term memory. The patients historical vaccine included Flu vaccine injection in right arm deltoid muscle. The patient's concomitant medications included Oxycodone (5mg three times a day tablet) been taking for 3 years since she has brain tumor removed and for chronic body aches and Lyrica. On an unknown date, the patient gained 16 pounds. In Mar2021, the patient experienced she passed out at home and she was very depressed, anxiety, panic attack, body ache/pain, vomited and loss of appetite. On 04Mar2021, the patient experienced right arm swelling, screaming, scary, memory was gone. On an unknown date, she experienced developed acute delirium. On 06Mar2021, the patient had redness in arm. The patient was in the hospital for 4 days and was admitted on 14Mar2021. Her memory came back little by little and side effect of vaccine it says that if she had side effects from first one do not take second dose because it is worse and she is scared to be admitted to the hospital and does not want to experience that again. She was taking pain medication and did not tell her she cannot take Tylenol of course with body aches they did not tell her. It was not specific acute delirium it is a psychiatric disorder and she was wild and has never been like that before, she was tied up to the bed. The reporter states that she is disabled. She has bad vision and she is by herself at home. She is 5 1/2 already going down. She is not going to get the second one until get report results because it is ridiculous, and she is very nervous as she was admitted at night to the hospital. Body ache happened 24 to 36 hours after vaccine not that severely unusual as it went away, and she has a chronic illness and is in a wheelchair from chronic pain. Reporter stated she could not swallow liquid or eat food and she was scheduled for a cat scan, but she could not go since she has been on the phone with Pfizer to get truth and fairness. Reporter stated yesterday this started getting better. Reporter stated was discharged from hospital last Tuesday but had pain at home. Developed acute delirium: stated when she woke up in the ER the next day in few hours she was admitted and in the ER she was crazy and tried running even though she cannot run because she is paralyzed and she did not remember nothing. Reporter stated no she did not get it that when she was discharged, it had been 48 hours. Pain started 48 hours after the vaccine. She has chronic pain the pain is not that excruciating, and it has stopped. She could not remember what happened but just knew it was redness and hurt a lot. Her memory and everything came back. States she had MMR (as provided by Reporter ) done, because of pain in her whole body and everything came back negative. She had terrible pain, she asked to be given pain medication, and was given pain medication. Reporter stated it disappeared about one week now it disappeared and has recovered completely. Reporter stated black and blue inflammation and it does not hurt and the pain it went away. She was discharged from the hospital and discharge paper said second vaccine on 26Mar2021. She has been taking Oxycodone pain medication, reporter thinks she even got a higher dose since the pain was excruciating. The patient did not take any vaccines with 4 weeks. No Relevant Tests were performed. While providing an AE for the COVID vaccine she took Tylenol and Motrin as treatment, on top of it, but the pain didn't go away. She has been taking Oxycodone pain medication, reporter thinks she even got a higher dose since the pain was excruciating. The clinical outcome of events gained 16 pounds, passed out at home, depressed, anxiety, panic attack, body ache/pain, vomited and loss of appetite, right arm swelling, screaming, scary, developed acute delirium, redness in arm was unknown whereas of memory gone it was recovering/resolving.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events peripheral swelling, amnesia, delirium, loss of consciousness, depression, anxiety, panic attack, and erythema and the suspect drug. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
58 2021-04-12 pulmonary embolism Second vaccine received on 4/6/21. Pulmonary Embolism on 4/11/21. Death on 4/13/21.
58 2021-04-21 blood pressure increased inflammation in sinuses and ears, sore throat-was tested for strep and covid and both negative. Deve... Read more
inflammation in sinuses and ears, sore throat-was tested for strep and covid and both negative. Developed tinnitus in left ear(same side as shot) on day 5 and had plugged ear. Have never had tinnitus in the past. Blood pressure went up by 30 points. Have generally not felt well since vaccine. Doctors called it an adverse immune reaction. Week 3-thyroid swelled and am now dealing with that. Went for ultrasound today
58 2021-04-24 chest pain Prinzmetal Angina; Chest pain; This is a spontaneous report from a contactable other health professi... Read more
Prinzmetal Angina; Chest pain; This is a spontaneous report from a contactable other health professional (patient). A 58-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 08Feb2021 08:00 (Lot Number: EM9810) at the age of 58-year-old as single dose for covid-19 immunisation. Medical history included ongoing High BP that was under control with medication from 2016, ongoing low Thyroid from 2017, Low Potassium 3.1 on 06Feb2021. The patient's concomitant medication was none. The patient previously received the first dose of BNT162B2 on 18Jan2021 11:45 am (lot number: EL3247) with Anatomical Site of injection: Left at the age of 58 years old for covid-19 immunisation and experienced Chest Pain on 22Jan2021 15:00 which required visit to Physician Office, Chest Pain 06Feb2021 (Several days) which required visit to Emergency Room. Vaccination facility type was hospital. No Prior Vaccinations. The patient experienced chest pain on 26Feb2021. The event required visit to Emergency Room. Event Outcome reported as "Prinzmetal Angina". Relevant Tests includes: Covid-19 on 23Dec2020 with Result: (-); Covid-19 on 18Jan2021 with Result: (-); Covid-19 on 21Jan2021 with Result: (-); X- Ray Chest on 06Feb2021 with Result: (-); EKG on 06Feb2021 with Result: (-); Low Potassium on 06Feb2021 with Result: 3.1. The outcome of the events was unknown.
58 2021-04-24 lightheadedness She felt unstable and felt like she might pass out; swelling of my tongue and cheeks; swelling of my... Read more
She felt unstable and felt like she might pass out; swelling of my tongue and cheeks; swelling of my tongue and cheeks; cold rush throughout my body; hot flash; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 58 years of age), dose 2 via an unspecified route of administration, administered in arm left on 06Apr2021 09:45 (Batch/Lot Number: ER8734) as a single dose for COVID-19 immunisation. Medical history included acid reflux, pre type II diabetes, Hashimoto's disease and possible Sjogrens; she was allergic to shellfish and berries. The patient had unspecified concomitant medications. The patient previously took and had allergies to sulfur, epinephrine and lidocaine. Historical vaccine included PFIZER BIONTECH COVID 19 VACCINE (lot number EN6207) (at 58 years of age), dose 1 in the left arm on 16Mar2021 for COVID-19 immunisation. The patient was not pregnant. The patient had no covid prior vaccination. She has not been tested post vaccination. It was reported that on 06Apr2021 10 AM, after just 13 minutes (as reported) of the shot, the patient experienced swelling of her tongue and cheeks along with a cold rush throughout her body followed by a hot flash. She felt unstable and felt like she might pass out. The events resulted in Emergency room/department or urgent care. Therapeutic measures were taken as a result of the events- treatment included BENADRYL day 1 and Prednisone added day 2. The patient was recovering from the events.
59 2021-01-03 hypertension Woke up achy all over with fever and chills. BP was high, so took meds, but didn't help even after t... Read more
Woke up achy all over with fever and chills. BP was high, so took meds, but didn't help even after taking again later. Contacted physician and advised to come in. Different BP med given that helped. Woke up tired the next morning.
59 2021-01-04 hypertension Patient's reaction(s) noted during COVID vaccine observation period: Redness, swelling, or pain at t... Read more
Patient's reaction(s) noted during COVID vaccine observation period: Redness, swelling, or pain at the injection site, extending >2cm diameter area(states it feels like it's in her bones). Pain worse with movement. No redness/swelling. Actions Taken: VS taken and WNL, with the exception of BP being a little high for her. She was offered the opportunity to go to ED and declined saying that it is manageable and will take Tylenol.   Disposition: Patient declined ED visit
59 2021-01-04 heart rate increased after the vaccine on the 19th I woke up with a bad headache and sore throat, not intense I just fel... Read more
after the vaccine on the 19th I woke up with a bad headache and sore throat, not intense I just felt like I was getting sick I took Motrin, Over the weekend I had significant heart beating which was very out of the ordinary I saw my physician. It felt anaphylactic. Dr did not prescribe anything I was asked to watch my symptoms
59 2021-01-05 lightheadedness Extreme Dizziness, Blurry Vision, Near fainting and Nausea
59 2021-01-05 chest discomfort, lightheadedness, fast heart rate Post vaccination I waited required 15 minutes. Upon exiting building, presented with sever dizziness... Read more
Post vaccination I waited required 15 minutes. Upon exiting building, presented with sever dizziness, near syncopal episode, blurred vision, chest tightness, tachycardia, weakness, shortness of breath. . Returned to vaccination room, in obvious distress. Ushered by staff to chair. Unable to obtain BP via electronic machine, obtained manual , after about 10 or so minutes NIPB 106/69. Remained in room for 45 more minutes, symptoms slowly resolved. Remained with mild to moderate dizziness x 4 days. Headache, chills, chest tightness, weakness, lethargy, x 7 days..
59 2021-01-06 pulmonary embolism SOB started Saturday 01/02/2021 continued SOB Sunday 01/03/2021 and on Monday 01/04/2021 went to cli... Read more
SOB started Saturday 01/02/2021 continued SOB Sunday 01/03/2021 and on Monday 01/04/2021 went to clinic and saw a provider. Resulted in bilateral pulmonary emboli treated with Lovenox and Coumadin.
59 2021-01-07 fast heart rate Developed severe chills, body aches, mild fever of 100.5. Lasted about 30 hours. Treated with Tyleno... Read more
Developed severe chills, body aches, mild fever of 100.5. Lasted about 30 hours. Treated with Tylenol. Had to miss a day of work. Have lingering fatigue and headache after 2 days. Also morning after vaccination had about 5 minutes of tachycardia with HR of 165 bpm. Resolved after taking blood pressure which was 114/69 with HR of 85 bpm. No further episodes.
59 2021-01-07 blood pressure increased From Patient: I received my shot on 12/30/20. When I got to my car I was having some face numbnes... Read more
From Patient: I received my shot on 12/30/20. When I got to my car I was having some face numbness and tingling. I went back to work I also had some weakness and being tired but that went away and weakness in my legs but that went away didn?t last long. The numbness and tingling in my face and neck did not go away. My arm is still sore. I did go to the er last night cause my blood pressure was high at home and face still numb and tingling. Just thought I better check things out. Dr wasn?t sure if it was a reaction from the covid shot he was checking for stroke issues all tests he ran were good.
59 2021-01-07 heart rate increased, palpitations Headache; Fever: She said that she started with kind of chills and shakes; Fever: She said that she ... Read more
Headache; Fever: She said that she started with kind of chills and shakes; Fever: She said that she started with kind of chills and shakes; she was not feeling too good; real high heart rate that were in the 110's that last for lasted for hours; Fever; This is a spontaneous report from a contactable nurse reported for herself. A 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EK9231 and expiration date unknown), via intramuscular on left deltoid on 03Jan2021 09:13 at single dose for COVID-19 prophylaxis. The patient medical history and concomitant medications reported as none. The reporter is a registered nurse that reported that she had the first Covid-19 vaccine yesterday morning on 03Jan2021 and she had side effects. She reported that she had a fever, headache, and a real high heart rate that was in the 110's that last for lasted for hours. She said that she started with kind of chills and shakes 11 hours and 40 minutes after receiving the vaccine. One minute she was fine and the next minute she was feeling chilled. By the time she got home from her mother's house, which is a hours drive, she was not feeling too good. Her fever broke today 04Jan2021 at around 04:00 and when she checked her temperature it was 98.7 degrees. She said that 100.2 degrees was the highest temperature she recorded. The patient said that it was a mild fever. Her headache started about 22:00 03Jan2021. The patient said that she still has the headache a little bit and she has been treating it with Tylenol and it has gotten better. She said that she wears a fit bit that tracks her heart rate and she can hear her heartbeat in her ears and she could hear it going fast. Caller said that her heart rate was down to 98 beats per minute at 06:30 this morning. She said that her current heart rate was Body temperature. Caller said that her high heart rate had her very concerned. She said that it is not normal. She is supposed to go back on 30Jan2021 to get her 2nd injection. Should she still plan on getting the second part of the vaccine? The reporter assessed event real high heart rate that were in the 110's that last for lasted for hours as serious with medically significant. Other events were assessed as non serious. The outcome of the events fever and real high heart rate that were in the 110's that last for lasted for hours was recovered on 04Jan2020, outcome of the event headache was recovering, outcome of the other events was unknown.; Sender's Comments: Based on the close temporal relationship, the association between the event high heart rate with BNT162b2 can not be completely excluded.
59 2021-01-07 palpitations, fast heart rate Tachycardia Narrative: VACCINE ADMINISTERED APPROX 1050AM, PT REPORTED PALPITATIONS AT APPROX 1102,... Read more
Tachycardia Narrative: VACCINE ADMINISTERED APPROX 1050AM, PT REPORTED PALPITATIONS AT APPROX 1102, VITAL SIGNS CHECKED, HER 110-120s, PT SENT TO ED VIA W/C ACCOMPANIED BY RN & MD
59 2021-01-09 hypertension, chest discomfort Does not have Lot #. Left it at work. Dizzy 15 mins after. BP was high. Dizzy rest of day. Worked th... Read more
Does not have Lot #. Left it at work. Dizzy 15 mins after. BP was high. Dizzy rest of day. Worked the next day was ok. Started driving the next day on interstate 12/25/20, and had chest pressure. Pulled of in to a hospital their and had testing done. Went home had dizziness still. Went to her MD, the doc changed her blood pressure meds. She doesn't have the dizziness and the chest pressure any more. Blood pressure is still high and monitoring it a few times a day.
59 2021-01-10 chest discomfort Chest pressure. Took Tylenol
59 2021-01-10 chest discomfort That evening developed itching and had a rash over upper body and arms, still on arms in AM, went aw... Read more
That evening developed itching and had a rash over upper body and arms, still on arms in AM, went away on it's own, since then have episodes of chills and a trigger finger developed while sleeping on right #4 digit of Right hand, tightness in chest and last night developed pain in left arm and fingers that was very painful and did not respond to 800mg of Ibubrofen. Not sure if related.
59 2021-01-11 fainting 12/19 vaccination 12/20 10pm As soon as I lied down, room spinning. Went to sleep. Midnight on 12/21... Read more
12/19 vaccination 12/20 10pm As soon as I lied down, room spinning. Went to sleep. Midnight on 12/21; woke up 'not feeling well'; weakness, faint, shaky. You contacted your brother and proceeded to the ER. 2am started to feel better 3:30 am dishcarged home. Wope up at 6:30 am. Chills, achy. Went to work; felt chilled all Monday into the evening until eventually subsided. **2 negative COVID in Nov **Flonase for allergies **2nd Pfizer vaccination on 1/9/2020. Milder symptoms for couple of days, into Tuesday. 1/12/2021; mild chills, mild body aches.
59 2021-01-11 pallor After receiving the vaccine on 1/5/21 that night i had hard chills during the night, on 1/6/21 I dev... Read more
After receiving the vaccine on 1/5/21 that night i had hard chills during the night, on 1/6/21 I developed a goose egg size swelling under my left armpit, numbness, tingling in my hands, and feet that proceeded with coldness and parlor of my hands, this has occurred daily along with headaches, reddish blotchy patches on my skin. My symptoms progressed on 7 Jan to needle prick sensations all over my body, to include the numbness and tingling, cold hands and feet. On 8 Jan I went to see my doctor and explained my symptoms, labs were drawn. 12 Jan i was placed on Medrol Dose pack, symptoms stills present.
59 2021-01-11 blood glucose increased, palpitations Palpitations and anxiety. Resolved by the time she sought treatment in the ED. No rash, swelling.
59 2021-01-11 blood pressure increased patient complained of arm heaviness, lightheadedness, dizziness after receiving 2nd dose of COVID va... Read more
patient complained of arm heaviness, lightheadedness, dizziness after receiving 2nd dose of COVID vaccine - her blood pressure was elevated as well - she reports she had not taken her blood pressure medication prior to the vaccine. Patient received Acetaminophen and Lisinopril in Emergency Dept afterwards and discharged home.
59 2021-01-11 lightheadedness pre syncope; difficulty breathing; dizzy - after 20 minutes of monitoring patient refused emt
59 2021-01-12 palpitations @0950 about 10minutes post vaccination, patient complaint of anxiety and rapid heart rate. Patient h... Read more
@0950 about 10minutes post vaccination, patient complaint of anxiety and rapid heart rate. Patient has a history of allergies - anaphylaxis. Vitals taken: b/p 197/116, hr 70, temp 97.5, 02 sat 99% on r/a. States she has HTN and takes meds. She did take her medication this morning. With meds she is around 140s/80s. Stayed with us for about 30 minutes. Repeat vs 186/104 hr 68, 98% RA. Still reporting anxiety but states she feels her b/p is high because she is anxious. She never experienced SOB, difficulty breathing. Stated at first a little bit of a scratchy throat but that went away shortly after. She stayed until she felt less anxious.
59 2021-01-12 fainting, blood pressure decreased Went to bed not feeling well. My husband came to check on me approx. 12:30 am. He was unable to arou... Read more
Went to bed not feeling well. My husband came to check on me approx. 12:30 am. He was unable to arouse me. When he tried to get me up out of bed I collapsed and then had syncopal episode. He call 911. Paramedics could not get blood pressure and I was diaphoretic and body temp was cold. They rushed me to the hospital. My blood pressure was dangerously low along with my body temperature. I was given epinephrine and LEVOPHED to get a blood pressure. I was warmed up. Then I had GI issues of vomiting, diarrhea, nausea. I spend 4 days in hospital.
59 2021-01-13 hypertension About 10-20 minutes after receiving the vaccine, patient she started having a sensation of tongue s... Read more
About 10-20 minutes after receiving the vaccine, patient she started having a sensation of tongue swelling. Patient was treated with an IM injection of epinephrine and then transported down to the emergency department. Upon arrival to the ED, she felt markedly improved with no symptoms other than some mild nausea. Patient was treated with steroids and ondansetron.
59 2021-01-13 chest pain, palpitations right after vaccine, she went to the observation area. Once there she stated having heart palpitati... Read more
right after vaccine, she went to the observation area. Once there she stated having heart palpitations and chest pain. She was taken to the ED for evaluation
59 2021-01-14 loss of consciousness On 1/8 she took her 2nd dose of Pfizer vaccine around 3 PM. She went home in the evening and started... Read more
On 1/8 she took her 2nd dose of Pfizer vaccine around 3 PM. She went home in the evening and started sweating. She passed out. Her daughter was at home and she took her to the nearest hospital. Her BP was 60/34 and she had a temp of 100.3F on 1/8 during hospital admission. Her K was low. She received lot of fluids. She called our office on 1/10 and during the f/u she was still in the hospital. On 1/10 she has a temp of 98.4F and BP of 109/61. But she still has dizziness, nausea, anorexia and mild cough (Former smoker). COVID-19 test was done on 1/9, its negative. Dx was dehydration. Discharged from the hospital on 1/11, feels better but is tired. Will follow up with PCP on 1/16/21.
59 2021-01-14 blood pressure increased Resident had facial swelling this morning along with uncontrolled muscle movements and tremors. Resi... Read more
Resident had facial swelling this morning along with uncontrolled muscle movements and tremors. Residents blood pressure was elevated as well and she complained of nausea. Resident was fine this morning and the past several days with no complaints. This resident has a history of muscle spasms and tremors as well as some catatonic states in the past.
59 2021-01-14 fast heart rate, hypertension Tachycardia Hypertension (198/120) - no he of hypertension Lightheadedness
59 2021-01-14 lightheadedness Vasovagal reaction immediately upon administration of vaccine. Patient felt faint, requested to lie... Read more
Vasovagal reaction immediately upon administration of vaccine. Patient felt faint, requested to lie down on floor. Initial blood pressure reading approximately 5 minutes later was 92/54. Patient did not lose consciousness. Repeat blood pressure reading approximately 10 minutes after vaccine administration was 122/78 and patient reported feeling better. Patient was observed for an additional 20 minutes with improvement of symptoms.
59 2021-01-17 fast heart rate, fainting, palpitations, loss of consciousness 20-30 min post injection, patient experienced tachycardia, palpitations, shortness of breath, syncop... Read more
20-30 min post injection, patient experienced tachycardia, palpitations, shortness of breath, syncope, loss of consciousness. 911 contacted by nursing home staff. Patient was placed in nursing home bed, 1 EpiPen dose administered by clinic nurse (RN. Nursing home staff began supportive care, supplemental oxygen given. patient experienced petit mal seizure and was non-responsive for a few minutes. Eventually came to but was still unstable. Paramedics took over at this point and patient was evaluated and transferred to hospital.
59 2021-01-17 heart attack, chest pain, heart attack On 01/13/2021 at about 11pm I began having pain in both arms and across my chest. Also nausea and vo... Read more
On 01/13/2021 at about 11pm I began having pain in both arms and across my chest. Also nausea and vomiting. At midnight I went to the Emergency room and was diagnosed with a heart attack, underwent emergency catheterization and stent placement. I had complete occlusion of the right coronary artery
59 2021-01-18 hypertension Difficulty breathing, high blood pressure and heart rate. Very sick for the next 3 days...bedridden... Read more
Difficulty breathing, high blood pressure and heart rate. Very sick for the next 3 days...bedridden due to sickness; nausea, shaking, weakness, muscle aches, joint aches, severe headache, stomach pain, skin blisters, fever and chills, injection site pain, tiredness, dizziness. By the 4th day I am still weak and now I have skin blisters on my body in various places. Today is the 5th day and I still feel weak and slightly sick, nausea and fatigue and more skin blisters, fever.
59 2021-01-18 chest pain Hours after shot my upper arm started hurting. The pain went around to my upper left chest and upper... Read more
Hours after shot my upper arm started hurting. The pain went around to my upper left chest and upper left back and up my lest side of next. Two days later I broke out in shingles. Dr put me in dexamethasone and famciclovir
59 2021-01-19 hypertension Patient received Covid vaccine, had sudden onset of flushed feeling, nausea no emesis, "dizzy/Fuzzy ... Read more
Patient received Covid vaccine, had sudden onset of flushed feeling, nausea no emesis, "dizzy/Fuzzy head" feeling. Hypertensive at time BP left arm 171/95 HR 79, RR 26, 99% RA. Apple juice, and cracker provided, and emesis bag provided. Patient was already waiting for thirty minutes time (she was 15 minutes into her wait time). She reported having a progression of nausea and dizziness Repeat vital signs at 1345 139/100 HR 76, RR 24 Pox 96% RA. First responder was called and patient was assisted into wheelchair and taken to the ER for further evaluation.
59 2021-01-19 chest pain Within 1-2 days after COVID vaccine developed dysphagia and vise-like chest pain within a few second... Read more
Within 1-2 days after COVID vaccine developed dysphagia and vise-like chest pain within a few seconds of swallowing.
59 2021-01-21 hypertension, chest discomfort Patient began complaining of weakness and chest pressure after receiving COVID-19 vaccine. A code bl... Read more
Patient began complaining of weakness and chest pressure after receiving COVID-19 vaccine. A code blue was called, and the patient was taken to the emergency department for further workup. In the ED, the patient was evaluated for hypertension and chest pressure and subsequently discharged after a negative workup (normal EKG, normal troponin). On 1/17, the patient returned to the ED with complaints of numbness in the left arm from fingertips to elbow, with sensation slowly returning over the next 10 minutes. A head CT scan was performed, showing bilateral acute on chronic subdural hemorrhage (possibly related to fall patient reported having on 12/5/20 down 10 steps of stairs). The patient was eventually discharged on 1/19.
59 2021-01-24 heart rate increased Approximately 10 minutes post injection, subject began to feel throat tighten. After taking a drink ... Read more
Approximately 10 minutes post injection, subject began to feel throat tighten. After taking a drink of water, the subject felt the throat tightness becoming worse. The patient could talk but her voice wounded horse. Heart rate increased. After consulting with physician at vaccine administration site, patient was transferred to the emergency room for treatment. Blood pressure was 200/100 in the emergency room. Patient was treated with benadryl, steroids and pepcid. Patient recovered
59 2021-01-24 chest discomfort soreness at injection site x 2 days, bruising, and edema at site of injection x ~ 1 week, Diarrhea ... Read more
soreness at injection site x 2 days, bruising, and edema at site of injection x ~ 1 week, Diarrhea x 5-8 days, colon pain/inflammation x 3-4 days, indigestion/chest heaviness continue til yesterday not as bad worse the first 3 to 8 days, now briefly during day
59 2021-01-25 chest discomfort ears are plugged; cough; stuffy head; diarrhea; tired/very fatigued; body aches; Chest heaviness/hea... Read more
ears are plugged; cough; stuffy head; diarrhea; tired/very fatigued; body aches; Chest heaviness/heavy chest; bad head cold/heavy duty cold; stuffy nose; headache; Swollen glands; Sore throat; Chills; Nausea; Runny nose; This is a spontaneous report from a 'contactable consumer and a physician. A 59-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140, expiry date not reported), via an unspecified route of administration in the left arm on 11Jan2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (lot number: EJT685, expiry date not reported) intramuscular in the left arm on 19Dec2020 at single dose for COVID-19 immunisation. On 11Jan2021, the patient felt tired/very fatigued, had body aches, chest heaviness/heavy chest, bad head cold/heavy duty cold, stuffy nose, headache, swollen glands, sore throat, chills, nausea, runny nose, ears are plugged, and diarrhea. On 12Jan2020, the patient experienced cough and stuffy head. Therapeutic measures were taken as a result of bad head cold. Clinical outcome of the events was unknown.
59 2021-01-26 heart rate increased 1/19/21 headache, sore throat, muscle and bone pain, neck pain, nausea. Everything resolved on 1/20... Read more
1/19/21 headache, sore throat, muscle and bone pain, neck pain, nausea. Everything resolved on 1/20 and 1/21. 01/22/21 awakened at 4am with "head itching", dizzy, headache, numbness in arms, nausea. In the evening hives started on hands/back/legs. 01/23/21 Went to Urgent Care because hands "felt like I had them on a hot plate, burning".
59 2021-01-26 chest discomfort Immediate ear to throat throbbing, arms tingling, chest heaviness, extreme fatigue within 25 minute... Read more
Immediate ear to throat throbbing, arms tingling, chest heaviness, extreme fatigue within 25 minutes of injection, lasted approximately 30 minutes
59 2021-01-26 chest pain, oxygen saturation decreased Shortness of breath; chest was hurting; Headache; Feeling tired; Joint aches; oxygen at the time, an... Read more
Shortness of breath; chest was hurting; Headache; Feeling tired; Joint aches; oxygen at the time, and it was 89 to 90; achy; This is a spontaneous report from a contactable nurse (patient). A 59-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration right deltoid on 09Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; unknown lot number and expiration) on 21Dec2020 via injection in left deltoid for COVID-19 immunization. The patient reported that she feels fine today (13Jan2021), but she received her second dose of the COVID vaccine on Saturday, 09Jan2021. She experienced side effects including headache, feeling tired, and joint aches on 11Jan2021. She also experienced shortness of breath on 12Jan2021. The shortness of breath started early Tuesday morning in the middle of the night. She would say that it was like her chest was hurting. She measured her oxygen at the time, and it was 89 to 90 (Jan2021). It gradually went up from there. This lasted about 3 hours. She is fine now. She would say these are all not serious as she knew it could be from the vaccine and she was keeping an eye on it. She could get up and do things she was just achy (Jan2021). It took her by surprise. She does not know if this is a known side effect or if it should be expected or if she should report this. The patient recovered from the events "oxygen at the time, and it was 89 to 90" on unspecified date; headache and joint aches on 11Jan2021; shortness of breath and "chest was hurting" on 12Jan2021; feeling tired on 13Jan2021; while unknown outcome for the remaining events. The events shortness of breath, joint aches, feeling tired, and headache were assessed as related to COVID vaccine by the reporter. The event shortness of breath, feeling tired, joint aches, and headache was assessed as non-serious Information on the lot/batch number has been requested.
59 2021-01-26 chest pain Throat tightness/numbness; Throat tightness/numbness; Shortness of breath w/min exertion; Dull chest... Read more
Throat tightness/numbness; Throat tightness/numbness; Shortness of breath w/min exertion; Dull chest pain; Right calf pain/cramping; Right calf pain/cramping; Fever; Chill; Body aches; Severe headache; Left arm swelling; left arm swelling, redness, knot; left arm swelling, redness, knot; Pain at injection site; Fatigue; This is a spontaneous report received from a contactable nurse (who is also the patient). A 59-year-old female patient received the second dose of BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284, expiry date: unknown), intramuscular in the left arm, on 11Jan2021 07:30, at single dose, for COVID-19 immunization, in the hospital. Medical history included COVID-19 (COVID prior vaccination: Yes) and known allergies to penicillin and erythromycin. There were no concomitant medications. Historical vaccine included the first dose of BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899, expiry date: unknown), intramuscular in the left arm, on 23Dec2020 07:15, for COVID-19 immunization. The patient experienced shortness of breath w/min exertion, right calf pain/cramping, fever, chill, body aches, severe headache, left arm swelling, redness, knot and pain at injection site, dull chest pain, fatigue, throat tightness/numbness on 11Jan2021. The events resulted to emergency room/department or urgent care visit. The patient did not receive treatment for the events. The patient was not tested for COVID-19 post vaccination. The outcome of the events was not recovered.; Sender's Comments: The 59-year-old patient received the second dose of BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE) on 11Jan2021, and experienced shortness of breath w/min exertion, dull chest pain, throat tightness/numbness and other symptoms on the same day. Considering plausible temporal relationship, the events were probably related to the second dose of BNT162B2. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
59 2021-01-28 fast heart rate, blood pressure increased 5 min after vaccine blood pressure 205/198 with tachycardia went to E.R. for 4 hours
59 2021-01-28 blood pressure increased, heart rate increased Elevated heart rate; Elevated blood pressure; Lightheadedness; Shakiness; This is a spontaneous repo... Read more
Elevated heart rate; Elevated blood pressure; Lightheadedness; Shakiness; This is a spontaneous report from a contactable nurse. A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL9261), via an unspecified route of administration on 15Jan2021, on 15:45 as the first single dose for an unspecified indication. Medical history included breast cancer from an unknown date, osteoarthritis from an unknown date, vasovagal syndrome from an unknown date, and sulfa allergy. Concomitant medication included ergocalciferol (VIT D), tocopherol (VIT E [TOCOPHEROL]), glucosamine (MANUFACTURER UNKNOWN), curcuma longa (TURMERIC). The patient previously took cefalexin (KEFKEX) and experienced drug hypersensitivity, levofloxacin (LEVAQUIN), and experienced drug allergy. The patient experienced elevated heart rate on 15Jan2021, at 16:00 with outcome of recovered with sequelae; elevated blood pressure on 15Jan2021, at 16:00 with outcome of recovered with sequelae in Jan2021; lightheadedness on 15Jan2021, at 16:00 with outcome of recovered with sequelae in Jan2021; shakiness on 15Jan2021, at 16:00 with outcome of recovered with sequelae in Jan2021. The patient recovered with lasting effects with no treatment. There was no Covid test post vaccination. The patient underwent lab tests and procedures which included blood pressure measurement and heart rate which were elevated in 15Jan2021.
59 2021-01-28 fainting Patient fainted after receiving the vaccine. BP 95/75HR 100, O2Sat100%. PAtient was transferred to s... Read more
Patient fainted after receiving the vaccine. BP 95/75HR 100, O2Sat100%. PAtient was transferred to stretcher BP 106/65, HR 79, O2Sat 100% CAT team was called Patient was transferred to ED
59 2021-01-28 palpitations Severe headache, palpitations, chills - started at 3am - lasted till 9pm
59 2021-01-28 fast heart rate, pallor The vaccine was given to me. Within 5 minutes my throat felt strange so I went get water. I went pal... Read more
The vaccine was given to me. Within 5 minutes my throat felt strange so I went get water. I went pale and blood pressure was 205/198 along with tachycardia. Spent hours in E.R.
59 2021-01-29 chest discomfort Nausea, heaviness in my chest, then difficulty breathing within 10-12 minutes following second dos... Read more
Nausea, heaviness in my chest, then difficulty breathing within 10-12 minutes following second dose administration into Right arm at 16:59. I took my albuterol inhaler, which did very little, so i added 20 mg prednisone tablet that i carry with me for emergency. Benadryl/Aleve mix (2 Aleve pm) taken at bedtime to assist in sleep and reaction. By 7:30 am i could not breath, peak flow meter revealed reduction to 68% capacity, so I took 60 mg prednisone, continued with albuterol inhaler q 4 hours,as i did the evening before. Then added Montelekust and allegra (antihistamine). Fever reached 99.4 degrees Fahrenheit, taken Temporal method- high for me, as i run low. An hour later, elevated temp to 100.5, same method, and has remained throughout the day and evening.
59 2021-01-31 heart rate decreased Pulse dropped to 35 bpm, starting feeling better within 90 minutes
59 2021-02-02 blood pressure increased, hypertension 45 minutes aFTer vaccination starTed nausea/dizziness, Quickly escalated to vomiting, Hyperventilati... Read more
45 minutes aFTer vaccination starTed nausea/dizziness, Quickly escalated to vomiting, Hyperventilating, increased B/P 200+/130+, decreased Responsiveness, tunnel vision, pin point pupils and no response to verbal and tactile cues For about 10 minutes. Transported to Hospital. Have Residual HTN.
59 2021-02-03 palpitations, heart rate increased Symptoms: c/o dizziness, palpitations, tremors, chills. HR 132. Other vitals stable. Intervention: ... Read more
Symptoms: c/o dizziness, palpitations, tremors, chills. HR 132. Other vitals stable. Intervention: Rest, reassurance, warm water, HR down to 98. Stabilized.
59 2021-02-04 loss of consciousness Symptoms started a few hours after vaccination. Initial symptoms were injection site pain and tired... Read more
Symptoms started a few hours after vaccination. Initial symptoms were injection site pain and tiredness. I later developed a mild headache, moderate muscle and joint pain, to which I applied a heating pad. I then developed a low fever and chills. Temp was 99.7 11:30pm on Feb 4, and 99.9 at 10:20 on Feb 5. I then began to feel nauseous and generally terrible, so I went to the bathroom, where I fell and may have passed out.
59 2021-02-04 chest pain, blood pressure increased, fast heart rate severe generalized burning pain, tachycardia, elevated blood pressure, dizziness, chest pain, stomac... Read more
severe generalized burning pain, tachycardia, elevated blood pressure, dizziness, chest pain, stomach pain, headache daily starting on 01/06/2021 to 01/27/2021; moderate generalized burning pain, tachycardia, elevated blood pressure 1/27/2021 to now; daily use Cymbalta for neuropathy pain; Amlodipine for high blood pressure; undergoing cardiology evaluation, continuing neurology visits; pending endocrinology evaluation
59 2021-02-05 hypotension Headache, cold, fatigue, and low blood pressure.
59 2021-02-06 hypertension Adverse event: Anaphylaxis reaction. High blood pressure. Body shivering. Rash on neck and chest. T... Read more
Adverse event: Anaphylaxis reaction. High blood pressure. Body shivering. Rash on neck and chest. Treatment: dexAMETHasone sodium phos (PF) given at 4:49 pm. diphenhydrAMINE (Benadryl) given at 4:46 pm. famotidine (PEPCID) given at 4:47 pm.
59 2021-02-07 blood pressure increased Pt complaint of dizziness 2 minutes after getting the vaccine. Pt the stated her vision was blurry.... Read more
Pt complaint of dizziness 2 minutes after getting the vaccine. Pt the stated her vision was blurry. BP 200/130 Pt stated she was feeling better. Medic rechecked BP 247-200/130. Medic rechecked 191/119, HR 68 @ 1310 Pt advised to go to ER. Pt doesn't want to go by squad. States she will call her daughter 1332 RN still monitoring pt. Pt sitting quietly waiting on her daughter to take her to ER as advised by medic. 1337 daughter of pt arrived. Rn supervisor walked pt to meet daughter and advised daughter take her to ER ASAP and to pull over squad if worsen. Pt advised to go to ER by medics & RN due to elevated BP, blurred vision, & dizziness.
59 2021-02-09 heart rate increased High pulse rate. Heart rate normally 62-65. 70 at rest today. While making lunch pulse rate 116-130.... Read more
High pulse rate. Heart rate normally 62-65. 70 at rest today. While making lunch pulse rate 116-130. Slept only 4 hours, feel shaky, and can feel pulse in neck and throat.
59 2021-02-14 blood pressure increased Adverse event: Anaphylaxis reaction. High blood pressure. Body shivering. Rash on neck and chest.; A... Read more
Adverse event: Anaphylaxis reaction. High blood pressure. Body shivering. Rash on neck and chest.; Adverse event: Anaphylaxis reaction. High blood pressure. Body shivering. Rash on neck and chest.; Adverse event: Anaphylaxis reaction. High blood pressure. Body shivering. Rash on neck and chest.; Adverse event: Anaphylaxis reaction. High blood pressure. Body shivering. Rash on neck and chest.; Adverse event: Anaphylaxis reaction. High blood pressure. Body shivering. Rash on neck and chest.; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL9269), via an unspecified route of administration into left arm on 06Feb2021, at 15:15 as first single dose for covid-19 immunization. Medical history included high blood pressure from an unknown date, known allergies to peanuts, tree nuts from an unknown date (elaborated as allergies to peanuts, non-steroidal-anti-inflammatory drugs (NSAIDs), tree nuts, penicillin), from unknown dates. Concomitant medication included lisinopril (MANUFACTURER UNKNOWN) and unspecified multivitamins. No other-vaccines were given with four weeks. On 06Feb2021, at 15:45, the patient experienced adverse event: anaphylaxis reaction. high blood pressure. body shivering. rash on neck and chest. The events were serious as they were life-threatening. The events were noted as resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, and was life threatening illness (immediate risk of death from the event). The patient underwent lab tests and procedures which included blood pressure measurement: high on 06Feb2021. Therapeutic measures were taken as a result of the adverse events; dexamethasone sodium phos- diphenhydramine (BENADRYL), famotidine. No covid infection was noted prior to vaccination. No covid test has been administered post vaccination. The outcome of events was recovered in Feb2021.
59 2021-02-17 cerebrovascular accident Bell's Palsy; Occipital Neuralgia; Stroke; Fever 101 degree; Myalgia; Headache/severe cephalgia; Blu... Read more
Bell's Palsy; Occipital Neuralgia; Stroke; Fever 101 degree; Myalgia; Headache/severe cephalgia; Blurred vision; dizziness; neuropathic pain; This is a spontaneous report from a contactable Physician (patient). A 59-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number ER9831, Intramuscular in left arm on 11Jan2021 08:20 at single dose for COVID prevention. Medical history included Asthma Moderate persistent on 20Jun2020. Concomitant medication was not reported. The patient previously received first dose of BNT162B2 on 23Dec2020 and experienced Aches, Fever 102 degree, myalgia, and headache. The patient experienced 101 degree, myalgia, Headache after the second dose of BNT162B2. The patient experienced Bell's palsy and occipital neuralgia on 28Jan2021 10:00 which resulted in stroke woke up and will lead to time off work and further imaging of cervical spine and possible nerve blocks. She had blurred vision and dizziness in addition to severe cephalgia and neuropathic pain. Treated with Aleve, steroids, Acyclovir + neurontin. Duration unknown as still with symptoms. The events Bell's palsy and occipital neuralgia resulted in Emergency room visit. Lab data included CT head with illegible Head Contrast, CT Angiogram head and MRI Head on 27Jan2021 with Result: NI. The outcome of Bell's palsy was Resolved with Sequel. The outcome of the event Stroke was unknown. The outcome of Fever 101 degree, Myalgia was resolved. The outcome of other events was not resolved.; Sender's Comments: The causal relationship between BNT162B2 and the reported events cannot be completely excluded based on temporal association. The information currently available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2020512578 Same patient/reporter,drug, different dose
59 2021-02-19 palpitations On January 16th I started feeling very dizzy in my eyes got blurry very dry mouth and palpitations,... Read more
On January 16th I started feeling very dizzy in my eyes got blurry very dry mouth and palpitations, and I almost passed out at home, my husband had to take me to Er. They wanted to keep me in the hospital but I told him I will follow up with my doctor on Monday, I did not want to stay on the floor with covid patients the test that they had ordered at the hospital were normal they did not order a CMP they only did a basic metabolic panel and that was normal, so I followed up with my doctor on Monday which was January 18th, and she ordered CMP and all the labs, when they threw my blood my liver enzymes were very elevated over the thousands LT ASG and the and others, then the doctor ordered a second set of blood works of CMP just to make sure it wasn't a fluke, they were even more elevated they were over 1,400.
59 2021-02-21 fainting Fainted on 2/11/2021, bowel incontinence, and vomiting
59 2021-02-23 chest discomfort, oxygen saturation decreased soreness in arm; achiness; Covid testing was positive/diagnosed with Covid-19; pulse ox 92 (lowest l... Read more
soreness in arm; achiness; Covid testing was positive/diagnosed with Covid-19; pulse ox 92 (lowest level); tightness in chest (no productive cough); This is a spontaneous report from a contactable nurse (patient). A 59-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via unspecified route of administration at the left arm on 10Jan2021 09:00 (lot number EJ1686 and expiry date unknown) at single dose for Covid-19 immunization in a hospital and not in a military facility. Medical history included asthma. Concomitant medications included albuterol [salbutamol] from unspecified date for unspecified indication. Historical vaccine included flu shot in Oct2020 for immunization and experienced some soreness in arm and achy. The patient was not given other vaccines given the same day or 4 weeks prior. In Jan2021, the patient had some soreness in arm and achiness (Jan2021) after the Pfizer BioNTech Covid-19 vaccine it didn't last long and she went to work afterwards. The patient was scheduled for work the next day and could tell something was not right. The patient was flushed and thought it was from the Albuterol since it can cause a racing heart beat and checked for a fever and didn't' have one. The patient checked temperature before bed and it was 100.5 degrees and she went straight to (redacted). The patient informed that she went for Covid testing; she went to physician office for Covid testing. The patient was praying for the flu so she could take Tamiflu and the flu test was negative (21Jan2021) and the Covid testing was positive (21Jan2021). The patient was tested positive after first Covid vaccine and ran fever 8 to 9 days and highest temperature was 101 degrees, had a little bit of asthma and kept a close watch, congestion, pulse ox 92 (lowest level), tightness in chest (no productive cough), felt beat up, fatigued and tiredness. The patient was diagnosed with Covid-19. She was told as well not to take pain relievers (ibuprofen, Advil and Aleve) and was advised to take Tylenol instead. The patient informed that she was to get her second dose tomorrow. The patient wanted to know if she can get the second dose if she was tested positive. The patient was supposedly scheduled to have the second dose on 27Jan2021 however it was moved to 04Feb2021 due to tested positive of Covid and was put on quarantined. The outcome of the events was recovering. The patient was unable to provide seriousness criteria when queried and said that this was her luck of the draw. The patient thought the shot actually helped.
59 2021-02-24 heart rate increased Difficulty breathing; swelling in face, neck, throat and tongue; swelling in face, neck, throat and ... Read more
Difficulty breathing; swelling in face, neck, throat and tongue; swelling in face, neck, throat and tongue; swelling in face, neck, throat and tongue; swelling in face, neck, throat and tongue; elevated heart rate; rash on face, neck and chest; Enlarged lymph nodes; dizziness; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient non-pregnant patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982), via an unspecified route of administration on right arm on 09Feb2021 at 15:45 at a single dose for COVID-19 immunisation in the hospital. Medical history was none. The patient had no allergies to medications, food, or other products. Concomitant medications included furosemide (LASIX) and other blood pressure meds (unspecified). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. On 09Feb2021, at 16:45 the patient had difficulty breathing, swelling in face, neck, throat and tongue, elevated heart rate, rash on face, neck and chest, enlarged lymph nodes and dizziness. The patient assessed the events as non-serious. Steroids, Benadryl, Pepcid, antibiotics were given as treatment in response to the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The patient was recovering from the events.
59 2021-02-25 loss of consciousness Patient began to deeply sweat, was lightheaded, dizzy, and was blacking out. It started 3 minutes af... Read more
Patient began to deeply sweat, was lightheaded, dizzy, and was blacking out. It started 3 minutes after she received the vaccine and also started with a weird iron taste in her mouth, and tingling in her hands. She felt like she was going to pass out but got better after 20 minutes. The tingling in her hands continued though and would start and stop periodically.
59 2021-02-27 blood pressure increased Within 5 minutes developed hives rash on face, neck and chest. Upon advise of personal physician, to... Read more
Within 5 minutes developed hives rash on face, neck and chest. Upon advise of personal physician, took 50 mg of Benadryl. Medical staff on site recommended being checked out by an ambulance EMT crew, due to ongoing hives and very high blood pressure reading by them. Ambulance called by site medical personnel, ambulance crew strongly recommend transport to ER. Went in ambulance to Hospital ER. In ER for roughly 3.5 hours for observation and vital signs monitored until rash subsided and blood pressure went down.
59 2021-02-28 heart rate increased nauseated; increased heart rate; feeling very unwell; pain was more severe in the arm and the rest o... Read more
nauseated; increased heart rate; feeling very unwell; pain was more severe in the arm and the rest of the body; arm swelling and pain; arm swelling and pain / pain was more severe in the arm; This is a spontaneous report from a contactable health professional, the patient. A 59-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EL9263,), via an unspecified route of administration on 26Jan2021 12:00 (at the age of 59-years-old) in the left arm as a single dose for COVID-19 immunization. Medical history included penicillin allergy, congenital heart defect. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included metoprolol. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EK4176) on 05Jan2021 at 16:00 (at the age of 59-years-old) in the left arm for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. On 27Jan2021 at 00:00 (on the 2nd day), the patient experienced arm swelling and pain. On 28Jan2021 (the 3rd day), the patient was nauseated, and the pain was more severe in the arm and the rest of the body, increased heart rate and overall feeling very unwell. The events resulted in a doctor or other healthcare professional visit. The patient was not treated for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of arm swelling and pain, nauseated, pain was more severe in the arm and the rest of the body, increased heart rate and overall feeling very unwell was not resolved.
59 2021-03-01 chest pain i woke up at 3am with chest pain on 01-11-2021. I went to the hospital and was diagnosed with perica... Read more
i woke up at 3am with chest pain on 01-11-2021. I went to the hospital and was diagnosed with pericarditis. At the hospital, an EKG, echocardiogram, US of the abdomen, MRI of the chest, lab work, cardiac marker series , CRP and a scheduled exercised test was done that picked up arrhythmia. I am now recovering and I am still taking Colchicine, a gout medication that treats inflammation and pericarditis. I am on this medication till mid April 2021 when I see my cardiologist for follow up.
59 2021-03-01 palpitations racing heart; fever 103; hard chills; headache; joints and bones felt like they were going to break;... Read more
racing heart; fever 103; hard chills; headache; joints and bones felt like they were going to break; joints and bones felt like they were going to break; no appetite; weakness, unable to get up out of bed; unable to get up out of bed; patient received second dose of BNT162B2; sjogrens disease/syndrome (immune disease); patient received second dose of BNT162B2; sjogrens disease/syndrome (immune disease); tired; This is a spontaneous report from a contactable other healthcare professional (patient). A 59-year-old female non-pregnant patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) lot number EL3302 and expiry date unknown, via unspecified route of administration on 09Feb2021 at single dose for Covid-19 immunization in a workplace clinic. Medical history included sjogrens disease/syndrome (immune disease), sulfa allergies. The patient's concomitant medications included several medications daily. The patient previously took morphine and experienced allergies and made her sick. Historical vaccine included first dose of BNT162B2, lot number EJ 1686 on 15Jan2021 for Covid-19 immunization. The patient has no Covid prior vaccination. On 09Feb2021 11:00 am (also reported as started 12 hours after 2nd shot), she experienced fever 103, hard chills, racing heart, headache, joints and bones felt like they were going to break, no appetite, weakness, unable to get up out of bed. The patient informed that the hardest time and highest fever was 11 PM to 6 AM Tue/Wed. The chills were severe, felt like her spine would snap into. The patient was still sick Wed (10Feb2021), the fever was not as high 101 to 102. The patient informed that what was scary was heart racing for hours that first night. The patient thought she was going to die. The patient informed that she didn't have heart problems, but she has Sjogrens, an immune disease. The patient informed that the fever was finally back to normal on Thursday (11Feb2021) afternoon after getting shot Tuesday noon. The patient informed that it's Sunday (14Feb2021) and she was still tired and has headache. The patient informed that it has to be something to do with Sjogrens. The patient informed that her rheumatologist said nobody so far had the kind of fever/reactions she had. The patient has not Covid tested post vaccination. The patient has explicit consent. The patient did not received treatment due to the events. The outcome of the events was recovering.; Sender's Comments: Based on the close temporal relationship, the association between the event "racing heart" with BNT162b2 can not be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
59 2021-03-03 chest discomfort her hands swelling and tightness; her hands swelling and tightness; underside of the forearms had a ... Read more
her hands swelling and tightness; her hands swelling and tightness; underside of the forearms had a lacey honeycomb pattern of red with white blotches; her cheeks were bright red; top of her hands to her wrist and lower arms were very red; felt light headed/faint and dizzy; tightness in her chest; the tightness that she felt the day before was in her lungs or throat; This is a spontaneous report from a contactable Physician reporting for his/her sister. A 59-year-old female patient received bnt162b2 (BNT162B2) via an unspecified route of administration at single dose in Jan2021 (12 days before reporting) for COVID-19 immunisation. Medical history included Hashimoto's autoimmune disease, enlarged thyroid, goitre. The patient's concomitant medications were not reported. In Jan2021, as soon as she got the injection, the patient felt both her hands swelling and tightness, underside of the forearms had a lacey honeycomb pattern of red with white blotches, top of her hands to her wrist and lower arms were very red, her cheeks were bright red, felt light headed/faint and dizzy, tightness in her chest and thought it was her heart. She was monitored for an hour but was told it probably wasn't an allergic reaction. Symptoms began to fade at that time. Next day she felt good and thought the tightness that she felt the day before was in her lungs or throat. The outcome of events was recovering. The events were reported as non serious. Reporter was referred to HCP or vaccination provider to determine if this was a severe allergic reaction and if she should receive the second dose of the vaccine. Information on the lot/batch number has been requested.
59 2021-03-03 palpitations mitral valve flare up; Heart palpatation; face numbness/ Numbness in right cheek; tingling finger/ t... Read more
mitral valve flare up; Heart palpatation; face numbness/ Numbness in right cheek; tingling finger/ tingling in right fingers; This is a spontaneous report from a contactable healthcare professional. A 59 -year-old female patient (not pregnant at time of vaccination) received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: En6201), via an unspecified route of administration (on left arm) on 18Feb2021 12:00 (at the age of 59-years-old), single dose for COVID-19 immunization. Medical history included high blood pressure from an unknown date. Concomitant medication included levothyroxine, propranolol, omeprazole (PROTONIX), linaclotide (LINZESS). The patient previously took codeine, prednisone, dtap, had known allergies: Codeine prednisone and dtap. The patient experienced heart palpitation, face numbness, tingling finger, all on 18Feb2021 1500. Numbness in right cheek and tingling in right fingers and motto valve flare up, all on 19Feb2021, the events resulted in Emergency room/department or urgent care.No treatment given for adverse events. The outcome of the events were recovering. No other vaccine in four weeks. No covid prior vaccination. Not covid tested post vaccination.; Sender's Comments: Based on available information, the Company considered all reported serious and non-serious events as possibly associated to BNT162B2 injection, due to a plausible chronological relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
59 2021-03-03 palpitations shaky, nervous, palpitations. Evaluated by EMS-Cleared
59 2021-03-04 blood pressure increased Pt developed vertigo and high BP of 202/120. 1 hour after vaccine administration Went to Ed and fu... Read more
Pt developed vertigo and high BP of 202/120. 1 hour after vaccine administration Went to Ed and full neurological and lab work up completed. NO significant findings noted. NO medications or treatments administered. Follow up with PCP the next day was unremarkable. All symptoms resoled in 3 hours.
59 2021-03-04 blood pressure increased Tingling in Hands and Feet Blood Pressure Spike Nausea Cramping Dizziness / Lightheaded
59 2021-03-09 cerebrovascular accident having a small stroke; weakness in her right hand and arm; Right arm was really sore; really tired; ... Read more
having a small stroke; weakness in her right hand and arm; Right arm was really sore; really tired; Headache; having issues with her right hand being numb/1st 2 fingers on her right hand were numb; The initial safety information received was reporting only non-serious adverse drug reactions, Upon receipt of follow-up information on 01Mar2021, this case now contains serious adverse reaction. Information processed together. This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6200, expiry date was not reported) (at 59 years of age), via an unspecified route of administration in the right arm on 20Feb2021 15:49 at a single dose for COVID-19 immunisation. The patient's medical history and family medical history were none. The concomitant medications were not reported. Historical vaccine included PFIZER BIONTECH COVID 19 VACCINE, 1st dose, lot number: EL9263, injection in right arm on 30Jan2021 (at 59 years of age). There was no other vaccines administered on same date with the Pfizer vaccine and there was no any other vaccinations within four weeks prior to the first administration date of the vaccine. The patient stated that she is not an HCP, but she does work in a mental health. She stated that she is concerned. She got her 2nd dose of the vaccine on Saturday and was having weakness in her right hand and arm. She asked if this was expected. She added that when she got up yesterday, her right arm was really sore, she was extremely tired, and she had a headache. She went to bed early that night at around 5:30pm, and she woke up around 8 or 9pm that night and tried to pick up her phone and couldn't. She stated that the 1st 2 fingers on her right hand were numb. When she got up today it was fine. They are working from home, so she was typing some notes and then it felt like her fingers went numb, it felt like her 1st finger was like rubber. She stated that the numbness comes and goes. She mentioned that she doesn't have a headache right now, but it felt like it could come back. The events did not require emergency room or physician visit. On 01Mar2021, it was reported that the patient was having issues with her right hand being numb and the representative that she spoke with recommended she follow up with her PCP, which she did, and they diagnosed her with having a small stroke and also referred her to a neurologist as well. She said that her primary care provider she saw was a nurse practitioner. She said that she also saw a neurologist. It was not reported if the patient received treatment for 'having a small stroke' while no treatment received for all other events. The outcome of having a small stroke was unknown; 'weakness in her right hand and arm' was not recovered; while 'Right arm was really sore' and 'really tired' was recovering. The outcome of Headache and 'having issues with her right hand being numb/1st 2 fingers on her right hand were numb' was recovered on an unknown date.
59 2021-03-10 chest discomfort, blood glucose increased, platelet count decreased, chest pain Patient had dizziness after receiving vaccine. Evaluated by clinic staff - then reporting throat ti... Read more
Patient had dizziness after receiving vaccine. Evaluated by clinic staff - then reporting throat tightness and reported having left shoulder pain for the prior 1.5 hours. patient was sent to the ED by EMS. The pt states that she had her first covid vaccine injection today and less than 30 minutes after her vaccine she developed acute central chest pain radiating to her left shoulder. She was given a full dose asa and 1 SL nitro by EMS. She states her chest pain was a 9/10 and it was pressure and tightness. She had associated lightheadedness. She states her pain is much worse than her typical chest pain she gets at home and takes nitro for. She states she is unsure if it is exertional, it is not worsened by deep breathing or palpation. She denies syncope, facial swelling, diaphoresis, n/v, abdominal pain, and hx of allergic reactions from vaccines.
59 2021-03-22 hypertension Started having a severe reaction after I received the vaccine, my symptoms started at around 6:30 PM... Read more
Started having a severe reaction after I received the vaccine, my symptoms started at around 6:30 PM I started to get very red and my face was swollen then I started to have a difficultly in breathing then I felt dizzy and I had a high fever and I started vomiting. and my blood pressure was very high. Then I called 911 and I was transferred to the Emergency hospital.
59 2021-03-22 chest pain shortness of breath chest pain respiratory failure with hypoxia multifocal pnuemonia
59 2021-03-25 low platelet count thrombocytopenia
59 2021-03-28 chest pain, chest discomfort Covid exposure on 3/3/2021. 3/9/2021 received first Pfizer vac. Within an hour was nauseated wit... Read more
Covid exposure on 3/3/2021. 3/9/2021 received first Pfizer vac. Within an hour was nauseated with pressure pain across the top of her stomach "under her ribs" and nausea. 3/10/2021 dev fever, weakness, and cough. Covid test 3/12/2021 neg. Eval in walk in clinic. Diag allergies. Rx oral steroid and Amoxicillin. A couple of days later, symptoms still continued. Eval in her physician's office 3/18/2021. Given steroid injection and antibiotic changed to Azithromycin. 3/19/2021 felt worse with pain/pressure under ribs and upper abd. eval in ER. O2 sat 87 improved to 93 with oxygen. Labs, chest xray, and CT scan obtained. Covid test neg. Admitted to hosp with diag of bilat pneumonia. Discharged on 3/22/2921 with steroids to take over next 5 days. She continues to have mild cough and pressure under her lower ribs. F/u appt scheduled with her physician. Was advised by her physician her pneumonia might be a reaction to the vaccine.
59 2021-03-28 low blood oxigenation Extreme rigors, fever, shortness of breath/hypoxemia within hours of receiving vaccine according to ... Read more
Extreme rigors, fever, shortness of breath/hypoxemia within hours of receiving vaccine according to staff at the care home. leukopenia, pulmonary edema, death
59 2021-03-29 blood pressure increased, heart rate increased, palpitations immediately following my left arm got a hot sensation, my hand went numb, and my fingers tingled. 1... Read more
immediately following my left arm got a hot sensation, my hand went numb, and my fingers tingled. 1 hour later I was nauseated and I had flu like symptoms, body aches, chills and a horrific headache. By 4th hour I needed to go to bed.
59 2021-03-30 platelet count decreased Went to ER at 10 pm on 03/24/21 with red bumps on feet and legs with difficulty swallowing. Blood d... Read more
Went to ER at 10 pm on 03/24/21 with red bumps on feet and legs with difficulty swallowing. Blood draw showed platelet count <3,000 and transferred to Hospital ICU at 4:30 am on Thursday, 03/25/21. Diagnosed with ITP at Hospital on 03/25/21. Received two (2) bags of donor platelets, steroids, and IVIG Treatment on 03/25/21 and 03/26/21. Following treatment, platelet count rose to 48,000 on 03/26/21 and 03/27/21. Discharged from hospital on 03/27/21 with follow-up with hematologist scheduled for 04/02/21. Platelet count on recent blood draw on 03/30/21 showed platelet count at 148,000 with continued treatment using steroids only.
59 2021-03-30 loss of consciousness When she passed out; feeling real dizzy; since her leg and knee feel bruised; right eye was swollen;... Read more
When she passed out; feeling real dizzy; since her leg and knee feel bruised; right eye was swollen; felt unwell; weak; This is a spontaneous report from a contactable consumer (patient) reported that a 59-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 13Mar2021 as a single dose (at the age of 59-years-old) for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the patient got the Pfizer-BioNTech COVID-19 Vaccine first dose on Saturday, 13Mar2021, and was fine after the shot but had a reaction on Sunday, 14Mar2021. On 14Mar2021, she got up to make breakfast and started feeling real dizzy and the next thing she knew, she was on the floor; this happened twice. When she passed out, she must have hit something on her right side, since her leg and knee feel bruised and right eye was swollen. She felt unwell, dizzy and weak; no dizziness today (15Mar2021). She planned to discuss further with her physician. The outcome of the event dizziness was recovered on 15Mar2021 and unknown for the rest of the events. Information on the lot/batch number has been requested.
59 2021-03-30 chest discomfort, chest pain coughing with a "wheezy sounding cough; she felt "not so good in my chest"; pain in chest; mild alle... Read more
coughing with a "wheezy sounding cough; she felt "not so good in my chest"; pain in chest; mild allergic reaction; a lot of pressure and pain and tightness in my ears; a lot of pressure and pain and tightness in my ears; This is a spontaneous report from a contactable consumer (reporting for herself) via the medical information team. A 59-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date: unknown), via an unspecified route of administration, administered in left arm on 03Mar2021 at 04:15 as single dose for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. On 03Mar2021 at 17:00 (reported as 05:00PM), the patient experienced mild allergic reaction. The patient waited for 15 minutes before leaving. On the way home, the patient experienced a lot of pressure and pain and tightness in her ears. She stated that she felt "not so good in her chest". The patient took 2 Benadryl to help. At 18:00 (reported as 06:00PM), the patient developed pain in her chest and was coughing with a "wheezy sounding cough". Her doctor instructed her to go to the emergency room where she was told she was having a mild to moderate reaction and was administered Albuterol. She states that the next day she was still coughing, but by the day after that, she felt fine. She states she already spoke with her doctor who recommended she not get the second shot. At the emergency room, they checked her pulse oximetry for the blood oxygen level. She had an albuterol treatment for her breathing. They listened to her chest with a stethoscope. The outcome of the event coughing, she felt "not so good in my chest", and pain in chest was recovered on 05Mar2021 while the outcome of the other events was recovered on an unspecified date. Information on the lot/batch number has been requested.
59 2021-04-01 fainting Fainted; Body chills; fever; body aches; Loss of appetite; Weakness; Sleepiness; This is a spontaneo... Read more
Fainted; Body chills; fever; body aches; Loss of appetite; Weakness; Sleepiness; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration, in the left arm on 19Mar2021 at 21:00 as a single dose for COVID-19 immunization. Medical history included COVID-19 from an unknown date to an unknown date, prior to vaccination. The patient had a nasal swab test for COVID on 18Mar2021 with a result of negative. The patient had no known allergies. There were no concomitant medications. The patient did not receive other vaccines in four weeks prior to the COVID vaccine. The patient experienced body chills, fever, body aches, loss of appetite, weakness, sleepiness and fainted on 20Mar2021 at 01:00. The patient did not receive treatment for the events. The outcome of the events was recovering. Information on batch/lot number was requested.
59 2021-04-02 cardiac arrest, chest pain brought in by EMS due to code. Started as CP and proceeded to cardiac arrest. Went into Vtach twice... Read more
brought in by EMS due to code. Started as CP and proceeded to cardiac arrest. Went into Vtach twice in the field. No cardiac issues other than HTN & afib. Per ED note, received COVID vaccine yesterday
59 2021-04-03 heart rate increased eyes were itchy; hard to breath; lips felt like they were getting puffy and they were bright red; li... Read more
eyes were itchy; hard to breath; lips felt like they were getting puffy and they were bright red; lips felt like they were getting puffy and they were bright red; tongue tingled but didn't swell; heartrate was 112 / heartrate was high; dizzy / lightheaded; vertigo; brain fog; trouble focusing; right arm was itchy and hot where she got the injection; right arm was itchy and hot where she got the injection; had a hard time forming sentences; really tired and sleepy; really tired and sleepy; chills; headache/I felt like my head was kind of throbbing; where the patient's thyroid is was swollen; couldn't really walk; had no balance; ringing in my ears; lost my voice.; This is a spontaneous report received from a contactable consumer, the patient. A 59-year-old-female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 15Mar2021 (at the age of 59-years-old) as a single dose for COVID-19 immunization. Medical history included allergic to a lot of medications/ antihistamines. Concomitant medications were not reported. The patient previously took diphenhydramine (BENADRYL) and was allergic. On 15Mar2021, within 2-3 minutes of vaccination, the patient's heartrate was 112, she started getting dizzy, lightheaded, and had vertigo. Her oxygen level was okay. On 15Mar2021, the patient also had some brain fog and trouble focusing, the right arm was itchy and hot where she got the injection, her eyes were itchy. The patient was then taken back to lie down. It was hard to breathe and she had to take large deep breaths. Her lips felt like they were getting puffy and they were bright red, she had a hard time forming sentences, was really tired and sleepy, had chills and a headache (felt like her head was kind of throbbing). Also, on 15Mar2021, where the patient's thyroid is was swollen, the patient couldn't really walk and had no balance, had ringing in her ears, her tongue tingled but didn't swell, the walls started moving and she lost her voice. The patient was kept for 2 hours and was almost sent to the ER. The patient brought an epinephrine (EPIPEN) but there was concern administering it because her heartrate was high. The patient questioned whether she should receive the second dose as she almost went into anaphylactic shock after the first dose. The clinical outcome of "right arm was itchy and hot where she got the injection" was resolved on 16Mar2021, of eyes were itchy, hard to breath, lips felt like they were getting puffy and they were bright red, tongue tingled but didn't swell, heartrate was 112 / heartrate was high, dizzy / lightheaded, vertigo, brain fog, trouble focusing, had a hard time forming sentences, really tired and sleepy, chills, headache/I felt like my head was kind of throbbing, where the patient's thyroid is was swollen, couldn't really walk, had no balance, ringing in my ears, lost my voice was unknown. Information on the lot/batch number has been requested.
59 2021-04-06 oxygen saturation decreased O2 level was 82-86/ Oxygen level was like 84 or 86 so she was put on oxygen; inflammation in the low... Read more
O2 level was 82-86/ Oxygen level was like 84 or 86 so she was put on oxygen; inflammation in the lower lungs that was rubbing on her diaphragm; Pneumonia; Cough/bad cough/dry cough; Stomach pain/top part of her stomach would hurt/stomach was hurting right at the bottom of her rib cage; gastroenteritis; short of breath; she wasn't breathing deep; feels like she doesn't have any energy; feeling bad; nauseated/felt sick to stomach; ate about half of her breakfast, this lasted for several days, she wouldn't eat much; This is a spontaneous report from a contactable consumer (patient's husband) via Pfizer. This consumer reported similar event for two patients. This is the first of two reports. A 59-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6206, expiry date: unknown), via an unspecified route of administration, on 09Mar2021, as single dose, for COVID-19 immunisation. Medical history included exposure to SARS-COV-2 on 02Mar2021 (reported as "daughter tested positive for COVID on 02Mar2021, patient had been around their daughter and their daughter's husband, they went out to eat with them on the night of 02Mar2021"). Concomitant medication included esomeprazole sodium (NEXIUM) taken for an unspecified indication, start and stop date were not reported. On 09Mar2021, the patient received her first shot. About 20 minutes after she took the shot, she started feeling bad and became nauseated/felt sick to stomach. On 09Mar2021, the top part of her stomach would hurt, and she started developing a cough. On 11Mar2021, the patient felt like she doesn't have any energy. The coughing went pretty bad so on 12Mar2021, the patient took a COVID-19 PCR test and it came back negative. The patient kept having a bad cough so then they went to the doctor where they put the patient on prednisone 20 mg and amoxicillin 875 mg on 12Mar2021. On 16Mar2021, the patient went to the family doctor and the doctor put the patient on azithromycin and gave her a steroid shot. Then the patient kept coughing and her stomach was hurting right at the bottom of her rib cage. The patient was never getting better or anything. So, on 18Mar2021, the patient had COVID-19 Virus test where they swabbed her nose and the test came back negative. The patient was taken to the hospital on 19Mar2021 at 11:30 where they did an x-ray of the patient's lungs and her O2 level was 82-86 sitting in the bed (also reported as 84-86 so she was put on oxygen), performed CT scan of her lungs and it looked like there was inflammation in the lower lungs that was rubbing on her diaphragm, and performed Chest CT which determined pneumonia. That night they did another COVID-19 virus test where they went really deep and it came back negative. The patient was admitted to the hospital on the night of 19Mar2021. The patient was given IV ceftriaxone, IV azithromycin, azithromycin (also reported as Zythromax), one breathing treatment, and they said they may have to send the patient home with some oxygen. It was also reported that on 19Mar2021, the patient did really good with coughing, she didn't cough that much. The patient had a dry cough that wasn't productive at all. The patient acted kind of short of breath because she wasn't breathing deep because of the pain in the top part of her stomach, but the reporter doesn't believe it was true shortness of breath. When the patient got out of the hospital on 22Mar2021, she didn't need to come home with the oxygen. The patient's oxygen level is running pretty good at the time of the report, in the lower 90s (Mar2021). The patient was on Decadron 6 mg for 5 days and she's doing pretty good, she still has a little bit of a cough. It was also reported that in Mar2021, the patient only ate about half of her breakfast, this lasted for several days, she wouldn't eat much. The patient pretty much recovered from the nausea. When she ate, it felt like everything would make it to her stomach and just sit there. The emergency room doctor said it could be from gastroenteritis, also they gave the patient several rounds of Protonix. The patient usually takes Nexium every night. The doctor felt that this event could very well be from the vaccine. The reporter asked if the patient could get the second shot on 30Mar2021. The patient was recovering from "Cough/bad cough/dry cough", "Stomach pain/top part of her stomach would hurt/stomach was hurting right at the bottom of her rib cage", and "O2 level was 82-86/ Oxygen level was like 84 or 86 so she was put on oxygen"; has recovered from "nauseated/felt sick to stomach" on an unspecified date. The outcome of the events "inflammation in the lower lungs that was rubbing on her diaphragm", pneumonia, "feeling bad", "ate about half of her breakfast, this lasted for several days, she wouldn't eat much", "feels like she doesn't have any energy", "gastroenteritis", "short of breath" and "she wasn't breathing deep" was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021329963 Same reporter, drug and event; different patient
59 2021-04-06 palpitations Received Covid vaccination/injection in right arm on 2/2/21. For the 1st four days, had occasional h... Read more
Received Covid vaccination/injection in right arm on 2/2/21. For the 1st four days, had occasional heart palpitations that lasted first 4 days then stopped--heart returned to normal with no more episodes. On 2/4/21, that night when I went to bed, I noticed a ringing in my left ear that became louder & louder as the next several days went by. I then noticed substantial hearing loss in my left ear. Also 2 days later, I started having a dull ache around my left ear along with the loud, high pitched ringing. I kept thinking it would get better but a week before my next vaccine, I called my ENT who monitors a small lesion & hearing in my left middle ear. I already had slight conductive hearing loss from this lesion and my last appointment/check up with her was in September 2020. Dr. had me come to the hospital on 3/11/21 and a hearing test was performed and my left ear hearing had declined 15 decibels since my last hearing test in Sept 2020. I was prescribed a Medrol Pak (steroids) for 1 week and returned on 3/23 for a 2nd hearing test with no improvement in my hearing or the loud ringing (tinnitus). The Dr. told me that my hearing test showed damage to the left ear nerve. I had also developed an inflamed, painful large sore under the left side of my tongue & was prescribed Triamcinolone Acetonide Dental Paste to use 2 x daily on the sore. The Dr. ordered an MRI of my brain & left ear to make sure the lesion in my ear had not grown. I had the MRI on 3/29/21 and returned to my Dr. on 3/30/21 for results. The lesion was stable, no growth. I made my own decision and did not return for my 2nd Covid vaccine because it appears the 1st vaccine either inflamed the nerve in my ear or caused an auto immune response.
59 2021-04-06 blood pressure decreased head aches; chills; weird feeling on head; left hand from elbow to finger tips began to numb then fe... Read more
head aches; chills; weird feeling on head; left hand from elbow to finger tips began to numb then few seconds right hand fingers began to numb, numbness to both hands; started feeling sweaty; shortness of breath; light headed; nausea; blood pressure drop to 40; The initial was missing the following minimum criteria: Unspecified AE. Upon receipt of follow-up information on 23Mar2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose at the age of 59-years-old via an unspecified route of administration, administered in arm left on 05Jan2021 (Batch/Lot Number: EL1284) as single dose for covid-19 immunisation. Medical history included atrial fibrillation, thyroid problem, hearing problem from an unknown date and unknown if ongoing, Stroke like paralysis from 2014 to an unknown date, gallbladder removal in 2018. Concomitant medications included sotalol, taken for atrial fibrillation from Dec2019 and ongoing; levothyroxine taken for thyroid disorder from 2017 and ongoing; cyanocobalamin (B-12) taken for an unspecified indication from 2014 and ongoing; aspirin [acetylsalicylic acid], taken for an unspecified indication from 2014 and ongoing. The patient experienced 3-5 minutes after the first dose on 05Jan2021, started feeling sweaty, shortness of breath, light headed, nausea, numbness to both hands. Next day 06Jan2021, wake up with numbness to left hands, head aches, chills, weird feeling in head (back left side of head). This went on for about 2 weeks lasted 1 month got better as days went day. It was also reported that she experienced that her left hand from elbow to finger tips began to numb then few seconds right hand fingers began to numb for period of 2 weeks. Her blood pressure drop to 40 on 05Jan2021. The patient underwent lab tests and procedures which included blood pressure measurement: drop to 40 on 05Jan2021, sars-cov-2 antibody test: 0 (came out 0 antibodies on my blood work had never been expose to anyone with Covid 19) on 24Nov2019, sars-cov-2 test: negative on 08Jan2021. The patient also reported that on 05Jan2021, she received the dose and had a reaction to it, but that same day her mother was taken to the hospital because she wasn't breathing well and she came out positive to Covid, she passed away 14 days after the patient took a test on Covid 08Jan2021 tested negative. She don't know if it was soon to be tested but other family member tested positive. The patient did not receive treatment for the events and was hospitalized due to the events. The patient did not recover from nausea, headache, chills while the outcome of the other events was unknown.
59 2021-04-07 loss of consciousness passed out; bad stomach ache; Tired; not normal; This is a spontaneous report from a contactable con... Read more
passed out; bad stomach ache; Tired; not normal; This is a spontaneous report from a contactable consumer (patient). A 59-year-old non-pregnant female patient received second dose of BNT162B2 (brand=Pfizer), lot no. EN60207, via an unspecified route of administration (left arm) on 19Mar2021 10:15 at a single dose for COVID-19 immunisation. The patient had no relevant medical history. She had no known allergies. No covid prior vaccination. Concomitant medications included levothyroxine, simvastatin, calcium, and multivimi (as reported). Historical vaccine included first dose of BNT162B2 (brand=Pfizer, lot no EN6203) on 26Feb2021 10:15 AM, left arm at age of 59 years. No other vaccine in four weeks. On 20Mar2021, the patient got up to go to bathroom at 4:00am Saturday and passed out. Bad stomach ache Saturday (20Mar2021), Sunday (21Mar2021). On Mar2021, tired and not normal til Thursday. No treatment for the events. No covid test post vaccination. The patient recovered from bad stomach ache on 21Mar2021 and from other events on Mar2021.
59 2021-04-12 fibrin d dimer increased, chest discomfort, pulmonary embolism To summarize our conversation, you stated that you received the second Pfizer vaccine on 3/4/21. Th... Read more
To summarize our conversation, you stated that you received the second Pfizer vaccine on 3/4/21. Three days later, on 3/7/21, you began to have fatigue, shortness of breath, dizziness and chest pressure. Because all symptoms continued for 24 hours, on the evening of 3/8/21, you took yourself to the Emergency Department. Your ER work-up included a CXR (negative), an EKG (showing a left bundle branch block), serum bloodwork (negative for MI), however, the D-dimer and spiral CT were both positive for a pulmonary emboli (i.e. a blood clot in your lungs). You were admitted to the hospital and started on the blood thinner, Eliquis. During your 3-day hospital stay, your work-up also included a bilateral lower extremity Doppler study (negative) and an echocardiogram (showing left ventricular hypertrophy). You were discharged on all of your previously prescribed medications (see list below), except for the fish oil. You were also started on Eliquis. Since discharge, you have followed up with your PCP and have been referred to a cardiologist and pulmonologist. To date, you have had no further symptoms. PAST MEDICAL HISTORY: hypertension, hypercholesterolemia, pre-diabetes. PRE-VACCINE MEDICATIONS: losartan, HCTZ, amlodipine, Welchol, fenofibrate, fish oil. POST-ER VISIT MEDICATIONS: losartan, HCTZ, amlodipine, Welchol, fenofibrate, Eliquis.
59 2021-04-13 blood pressure decreased Within two days. Drop in blood pressure and then severe vertigo
59 2021-04-17 heart attack, chest pain, hypertension chest pain; heart attack; headache; blood pressure was high; This is a spontaneous report from a con... Read more
chest pain; heart attack; headache; blood pressure was high; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 28Mar2021 09:15 at single dose in left arm for COVID-19 immunization. Medical history included Irregular heart beat. The patient had no Allergies to medications, food, or other products. Concomitant medications included acetylsalicylic acid (BAYER ASPIRIN), and metoprolol. The patient was not diagnosed with COVID-19 Prior to vaccination. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On Monday morning (29Mar2021 06:45), when the patient got out of bed she started having chest pain, took a shower and the pain got worse like she was having a heart attack, she was admitted to the hospital and treated for the pain and had EKG, stress test done, blood pressure was high, and she had a very bad headache; The events resulted Emergency room/department or urgent care. Tuesday morning (30Mar2021) the pain started to decreased and after another EKG and her blood pressure went down she was released and advised to follow up with her primary doctor as well as the cardiologist. Lab test included Nasal swab negative on 29Mar2021. Treatment was received for all events. The outcome of all events was resolved. Information on the lot/batch number has been requested.
59 2021-04-22 heart rate increased Her heart started pumping really hard; Fast heartbeat/Heart fluttering a lot; She also had pressure ... Read more
Her heart started pumping really hard; Fast heartbeat/Heart fluttering a lot; She also had pressure on the top part of her head which was tender and a pressure in the back part of her right eye.; She also had pressure on the top part of her head which was tender and a pressure in the back part of her right eye.; Anxiety; Eye felt red; This is a spontaneous report from a contactable consumer. A 59-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: E10142), dose 1 via an unspecified route of administration, administered in left arm on 14jan2021 at 09:00 as single dose for covid-19 immunisation. Medical history included vitamin supplementation, supplementation therapy, cataract (Mother had cataracts; problems with her heart; had a couple of strokes before she died at 59 years of age), cardiac disorder, cerebrovascular accident, pain (Before she had the first dose of Pfizer COVID-19 Vaccine she was not so concerned because she figured she would probably get body aches or headaches, normal side effects), headache, normal side effects. Concomitant medications included ergocalciferol (vitamin d [ergocalciferol), krill oil (megared omega 3 krill oil), vitamin c [ascorbic acid], nigella sativa seed (black seed [nigella sativa seed]), betacarotene, calcium carbonate, cyanocobalamin, folic acid, nicotinic acid, pyridoxine hydrochloride, riboflavin, sodium ascorbate, thiamine hydrochloride, tocopheryl acetate (one-a-day vitamin), cyanocobalamin (vitamin b12 [cyanocobalamin]), acetylsalicylic acid (baby aspirin), calcium, magnesium, zinc (magnesium/calcium/zinc) taken for vitamin supplementation and probiotics taken for supplementation therapy. No any other vaccinations within 4 weeks Prior to the first administration. No AE(s) following prior vaccinations: although she did get unknown Shingles vaccine in Sep2020, no AEs associated. She has not gone to get the second Shingles vaccine because she does not want to overlap vaccines while getting Pfizer COVID-19 Vaccine. The patient Was concerned for her 2nd dose which she was scheduled to take tomorrow on 02Feb2021 at 14:30, because of the side effects from her 1st dose. On 15Jan2020, a day after the 1st dose, her heart started pumping really hard and she had a fast heartbeat/ heart fluttering a lot. She also had pressure on the top part of her head which was tender and a pressure in the back part of her right eye. She it was strange because this has never happened to her before up until she got the vaccine. She consulted her eye doctor and mentioned that she will be monitored for the pressure in her right eye. She is also getting anxiety because of this. She was asking if she can go tomorrow to take the 2nd shot. The outcome of events her heart started pumping really hard, she also had pressure on the top part of her head which was tender and a pressure in the back part of her right eye, anxiety and eye felt red was unknow where the outcome of events fast heartbeat/heart fluttering a lot was not recovered. Follow-up attempts are completed. No further information is expected.
59 2021-04-24 hypertension Got violent shakes and chills; Got violent shakes and chills; Stomach pain; temperature suddenly got... Read more
Got violent shakes and chills; Got violent shakes and chills; Stomach pain; temperature suddenly got to 103.5; Blood Pressure was very high; flu like; 1st dose :20Mar2021; 2nd dose: 04Apr2021; 1st dose :20Mar2021; 2nd dose: 04Apr2021; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient not pregnant received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 04Apr2021 11:00 (Lot Number: EW0150) as single dose (at the age of 59-years-old) for covid-19 immunisation. Medical history included breast cancer, anxiety, depression, irritable bowel syndrome (IBS), Low Thyroid, arthritis. Patient had no known allergies. It was reported that patient received concomitant medications in two weeks prior to the vaccination, no details reported. Patient did not receive other vaccine in four weeks prior to the COVID vaccine. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, via an unspecified route of administration, administered in Arm Left (Lot number: ER2613) on 20Mar2021 12:00 PM (at the age of 59-years-old) for COVID-19 immunization. It was reported that patient received first dose on 20Mar2021 and second dose on 04Apr2021 (Inappropriate schedule). Patient stated that she had her second (2 nd) shot on 04Apr2021 (Sunday), was fine until 07Apr2021 (Wednesday). On 07Apr2021 at 15:00 she got violent shakes and chills, stomach pain, temperature suddenly got to 103.5. Patient went to Emergency room. Blood Pressure was very high. She was released and better on Friday but still flu like. They could find no reason for this and three doctors (Dr's) thought it was a reaction to the vaccine. Events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization. The patient was hospitalized for 3 days. She was treated with intravenous (IV's), Antibiotics, cat scan and X-ray, results unknown. The patient was not diagnosed with COVID-19 prior to vaccination and had been tested for COVID-19 post vaccination. The patient underwent laboratory tests and procedures which included sars-cov-2 test (Nasal Swab) negative on 07Apr2021. She was recovering from the events, at the time of the report.
59 2021-04-26 fainting A nurse saw me in distress & caught me before I hit the floor; dizziness & lightheadedness; difficul... Read more
A nurse saw me in distress & caught me before I hit the floor; dizziness & lightheadedness; difficulty breathing; had a horrific taste in my mouth; A nurse saw me in distress & caught me before I hit the floor; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in the right arm on 11Apr2021 at 11:15 (batch/lot number: EP7533) as a single dose for COVID-19 immunisation. Medical history included cancer history, back injury, right shoulder injury; and known allergies to sulfa, IVP dye, latex, bee stings and mushrooms. The patient was not pregnant. Facility type vaccine was health clinic. No other vaccine in four weeks. No Covid prior to vaccination and not Covid tested post vaccination. Concomitant medications in two weeks included gabapentin, valaciclovir, tramadol, doxycycline and vitamin; all taken for an unspecified indication, start and stop date were not reported. The patient previously took codeine, morphine and hydromorphone hcl (DILAUDID) and experienced known allergies to all drugs. On 11Apr2021 at 11:30, also reported as within 2 minutes of getting the vaccine, the patient had a horrific taste in her mouth followed by dizziness & lightheadedness. A nurse saw her in distress & caught her before she hit the floor. She then had difficulty breathing. They administered EpiPen, 50 mg liquid Benadryl & 2 puffs of Ventolin. She was transported to the ER by ambulance. The adverse events resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of the events. The outcome of the events was recovering.
59 2021-04-26 pulmonary embolism to make sure there is no pulmonary embolism; Shaking legs and arms; Lightheaded; PVCs (Ventricular p... Read more
to make sure there is no pulmonary embolism; Shaking legs and arms; Lightheaded; PVCs (Ventricular premature beat); Large black bruise on left breast; 40 hrs fever; throwing up/vomiting; nausea 36 hours; intermittent breathing issues/sporadic breathing issues/difficulty breathing and hard to get a breath; She was weak; severe migraine; Headache; Brain fog; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received second dose of bnt162b2 (BNT162B2, lot number ER8727, expiration date: 31Jul2021), via an unspecified route of administration in arm left on 07Apr2021 12:00 as single dose for Covid-19 immunisation. Medical history included allergy ( macro Danton, sulfa). Patient was not pregnant at time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medication included Nerontin. The patient reviously received flu vaccine and had normal things, previously received first dose of bnt162b2 (Lot Number: EN5318; Expiration Date: 31May2021) in arm left on 17Mar2021 16:00 and experienced acute lymphatic response, brain fog and arm started to hurt. The pateint was calling because her doctor, who she saw yesterday 14Apr2021, told her she should let Pfizer know what was going on. She had a reaction to the Pfizer Covid19 Vaccine. she was now having PVCs. The patient added that all of the events started with a fever, and throwing up. She had a fever and threw up for 36 hours. She had to contact her physician to get medication and to stop vomiting and the nausea and everything. During that time, she was sick. She was having intermittent breathing issues which she did not think she felt too much of until after the other sickness was over. She was weak, like people get after they are sick, and had bizarre shaking legs and arms which was strange. She added that she had breathing issues and difficulty breathing and hard to get a breath. That was what she was dealing with. Treatment: caller took Pedialyte and all the proper things to get back into better shape. The breathing issue still remained. The doctor called in a rescue inhaler. She kept going downhill so he called in a rescue inhaler. Large black bruise on left breast after second vaccine: Caller added that this one will not be believed but on Monday, she woke up and got dressed again and was just weak and had breathing issues but was just doing work on the laptop. She did not fall, she did not run into anything. In the evening, she went to take a bath and saw that when she took her clothes off there was a large black bruise on her left breast, it was probably 2 inches in diameter. It is very large, but does not hurt like a bruise. She checked the rest of her body for blood issues and only saw a couple normal looking bruises. She contacted her doctor, and they questioned her thoroughly on her bruising and activity. This was on Monday. Tuesday, she still felt the same headache, weak, and breathing issues. PVCs (Ventricular premature beat) after second vaccine: Yesterday, 14Apr2021, she started declining and the doctor wanted to see her. Caller stated the doctor heard PVCs in her heart. Caller asked clarification of PVC abbreviation and does not provide. She never had heart issues ever. The doctor did blood work and a chest x-ray, and saw the bruise and was worried about her blood. Caller added that even though these are not listed as side effects of the vaccine, she was worried. Her doctor sent her to a facility for chest x-rays to make sure there is no pulmonary embolism. Caller confirmed this was on 14Apr2021. She has not yet heard back. PVCs after second vaccine: Caller added the doctor said her lungs sounded good but wanted to see what was going on to see how her breathing was because there was difficulty. The doctor wanted to cover bases and check. Today, caller can tell her heart is still not in correct rhythm and that it is in continued PVCs. She still had the same breathing issues, limbs were weak, she was shaky, and she is lightheaded. She was hoping to wake up today and feel better. Fever after second vaccine: started 3am 08Apr2021. She had a fever and was throwing up at this time. Throwing up and nausea after second vaccine: caller add that throwing up and vomiting with nausea occurred at 3 am, all of this occurred 08APR2021. The vomiting lasted 36 hours, and it ended when she took medication. The fever lasted 40 hours. Even after the medication worked for her fever, she had nausea. Around Friday was when it went away. Intermittent breathing issues after second vaccine: caller adds it started with throwing up and fever, but she did not think a lot about this or know when it started because she was dealing with the fever and vomiting. It continued, and it has not subsided or ended. As a matter of fact, there are 2 or 3 times it has gotten bad which is why she was given an inhaler. Treatments: caller took a Phenergan suppository, which she adds is the best medicine in the World for nausea and beats Zofran. She had used two or three doses and it did work. She used a rescue inhaler, Albuterol Sulfate HFA. She took Tylenol for fever. She is also now taking an aspirin daily because of the blood issues. No additional information regarding the products. Weak after second vaccine: caller adds that this started at the same time, she was over the nausea and noticed this. It felt different than what it feels like with the flu. This is still going on, she did not think too much about it but it has persisted. Sometimes there is a little bit of shaking but that is intermittent. Caller states she can not put it into words. Bizarre shaking legs and arms after second vaccine: this goes with the weakness, she is continually weak but she has a shaky feeling that will come every now and then and is random. Large black bruise on left breast after second vaccine: Monday this started, 12APR2021 and it is still there but it is the same. It has not been sore like a bruise but it is black and large. The physician has seen it now and it is bizarre and scary. It is the left breast on the outside. Headache after second vaccine: started probably an hour after the vaccine, pretty quick. There were degrees to this headache because it was an actual migraine for a good 48 hours and even after the fever was gone it was terrible. It started out just a mild headache and then was very severe for a couple of days. Then, after that it was just there but not as severe. PVCs after second vaccine: caller adds that she went to the doctor yesterday 14APR2021 and she can tell every now and again that she is having these but there is nothing she can do about it. Caller adds this is everything new she can think of, but some of it is foggy, she thinks this is the main information. Brain fog after first and second vaccine: Caller then states, by the way, after both vaccines within 2 or 3 minutes of having them her head started feeling foggy and weird. Investigations: caller has not received any results yet. She did get an EKG, Chest XRAY, blood work, and the doctor also rattled off a bunch of things the doctor was going to check. These all were on 14Apr2021 and she is waiting on results. Caller confirms the physician told her she had PVCs while listening to caller's heart. Did any AE require a visit to: Physician office? 15Apr2021 she was in contact with her physician, and the whole week they were on the phone. Yesterday 14Apr2021 the physician wanted to see her. The doctor figured out something was going on with her heart so thankfully the doctor wanted to see her. It was discussed if caller should go to the ER but caller did everything she could not to go because that is the last place she wants to go. Emergency Room: no. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of fever, vomiting, nausea was recovered, intermittent breathing issues, shaking legs and arms, weak, severe migraine, headache was not recovered, for other events was unknown. No follow-up attempts are needed. No further information is expected.
59 2021-04-27 blood pressure decreased vertigo; Severe blood pressure drop; This is a spontaneous report from a contactable consumer (patie... Read more
vertigo; Severe blood pressure drop; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the left arm, on 22Mar2021 at 16:00 (Lot Number: EN6206) (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included sinusitis, gastrooesophageal reflux disease (GERD), iodine allergy, and shellfish allergy. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) and pantoprazole sodium sesquihydrate (PROTONIX). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced severe blood pressure drop on 24Mar2021 at 07:00 and vertigo on 26Mar2021, which caused hospitalization from 27Mar2021 to 03Apr2021 for 7 days. It was reported that the severe blood pressure drop occurred two days after vaccination and two days later, vertigo occurred. The patient underwent lab tests and procedures which included blood pressure: drop on 24Mar2021, COVID PCR (nasal swab): negative on 29Mar2021, and COVID PCR (blood test): negative on 04Apr2021. Therapeutic measures were taken as a result of the events, which included unspecified blood pressure medication, unspecified vertigo medication, and intravenous (IV) fluids. The clinical outcome of severe blood pressure drop and vertigo was not recovered.
59 2021-04-28 lightheadedness, loss of consciousness Lost consciousness; dizzy like she was about to faint; twitching and shaking; eyes went to one side;... Read more
Lost consciousness; dizzy like she was about to faint; twitching and shaking; eyes went to one side; she was about to faint; seizure; Diarrhea; chills; head hurting; eyes hurting; Muscle soreness; joint pain; Nausea; temperature of 99.3; This is a spontaneous report from a contactable consumer (daughter of patient) and another consumer. A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 13Apr2021 16:21 (Lot Number: EW0164; Expiration Date: Aug2021) at vaccination age of 59 years old as single dose for covid-19 immunisation. Medical history included vertigo, antacid therapy. Concomitant medication included esomeprazole magnesium (NEXIUM 24HR) taken for antacid therapy from an unspecified start date and ongoing. No additional vaccines administered on same date of the Pfizer Suspect. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot EP7533), on 23Mar2021 at 17:38 PM at age of 59 years old in the right arm as single dose for covid-19 immunisation and only had a little bit of muscle soreness on her right arm on 23Mar2021 after the first dose and it went away the day after (24Mar2021). The patient took Tetanus shot about two weeks before the first dose of the Pfizer COVID 19 vaccine. Then received the second dose on 13Apr2021 16:21PM in the left arm. After the second dose she had chills; her head was hurting; her eyes were hurting; she had muscle soreness; she had joint pain all yesterday 14Apr2021. Then this morning 15Apr2021, after taking a Tylenol and getting a shower she felt dizzy like she was about to faint. Her mother had vertigo but this was not like her usual vertigo. Her mother sat on the bed and started to have what looked like a seizure with twitching and shaking; then she lost consciousness. Her mother's eyes were open and they saw her mother's eyes twisted, went to one side, and she fell back on the bed. They called at 05:30 AM and the ambulance arrived quickly but by the time they arrived she had regained consciousness. They recommended she follow up with HCP. They called the doctor who advised her to rest, and make an appointment to see the doctor tomorrow. Reporter clarified her mother had the chills from 10:00 AM today (15Apr2021) and had them day with a lot of headache, eyes hurting goes along with the headache, and she had a temperature of 99.3. The chills and temperature resolved last night then the eyes hurting ended this morning (15Apr2021) with the headache. All of the other symptoms resolved yesterday (14Apr2021). She also had nausea that started yesterday (14Apr2021) and she started to have diarrhea once today (15Apr2021)and felt like it had stopped. The nausea was coming and going from time to time. The events did not require a visit to emergency room or physician office. The outcome of events chills, muscle soreness, joint pain, temperature of 99.3 was recovered on 14Apr2021. The outcome of events Lost consciousness, head hurting, eyes hurting, felt dizzy, twitching and shaking, eyes went to one side, Diarrhea was recovered on 15Apr2021. The outcome of event seizure, she was about to faint was unknown. The outcome of event nausea was recovering.
59 2021-04-28 blood clot blood clot under her eye; bright red bruise in the corner of the eye to the middle of the eye undern... Read more
blood clot under her eye; bright red bruise in the corner of the eye to the middle of the eye underneath; feeling crummy; she was down; headaches; couldn't move; arm hurt all the way below her arm pit into her breast; arm hurt all the way below her arm pit into her breast; arm hurt all the way below her arm pit into her breast; got very sick; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: ER8737), dose 1 via an unspecified route of administration, administered in Arm Left on 05Apr2021 08:30 (at the age of 59years) as single dose for Covid-19 immunization. Medical history included ongoing rheumatoid arthritis and osteoarthritis (not bad enough that she takes treatment, but she is diagnosed; she was diagnosed way back in 2006). Concomitant products: patient stated she takes some medications (not further specified). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that she had her first dose of the Pfizer Covid-19 vaccine on 05Apr2021 and got very sick. She was down for two days and after day 10 (as reported) she has a blood clot under her eye. She would like to know what would happen if does not get a second dose. She consulted if there is any talk on whether or not people should receive an additional dose of the Pfizer Covid-19 vaccine next year. The patient further reported that on 06Apr2021 she woke up feeling crummy right away and a couple of hours into that day she couldn't lift her arm, literally couldn't lift arm for 6 inches and stated it went on for 2 days. She further stated that her arm hurt all the way below her arm pit into her breast. She stated that it all ended on 08Apr2021 and she went back to work on 08Apr2021. The patient added that she was down for two days, had headaches, and stated she never knew what people meant when they said they got hit by train. She doesn't believe she had a fever and couldn't move. The patient further stated that she got pretty darn sick and this morning 14Apr2021, she woke up with a blood clot under her eye. She is an esthetician and is pretty good with skin. She stated that she doesn't know how she could get this overnight unless she injured herself in her sleep, but she is a light sleeper. She does not know if it is a clot. She also stated that she called a medical esthetician who told her to take a baby aspirin and cold compress. The patient clarified that she didn't feel so good and today she feels better. She doesn't know that it is a blood clot, it is not raised and not hard, it looks like she has a bright red bruise in the corner of the eye to the middle of the eye underneath, not in the eye. She wants to make it clear she doesn't know if it is a blood clot. She feels like if she hurt herself, that would be the reason, but it would be painful, and it is not. She added that the bruise is about the same. Therapeutic measures were taken as a result of the events (except for feeling down and couldn't move). The outcome of events thrombosis and contusion was not recovered; the outcome of other events was recovered on 08Apr2021.